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Diagnosis of Helicobacter pylori infection using urease rapid test in patients with bleeding duodenal ulcer: Influence of endoscopic signs and simultaneous corporal and antral biopsies

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Abstract

The sensitivity of invasive diagnostic methods for Helicobacter pylori (H. pylori) infection, particularly of urease rapid test, is decreased in cases of gastroduodenal ulcer and upper gastrointestinal bleeding. To assess the influence of blood in the stomach or recent bleeding endoscopic signs in the diagnostic sensitivity of urease rapid test among patients with bleeding duodenal ulcer, as well as the influence of simultaneously collecting corporal and antral biopsy samples. 120 patients, 85 male and 35 female, with an average age of 62 (18-88) years, who were admitted to our Hospital due to bleeding duodenal ulcer and who received an endoscopic diagnosis within 24 hours of admission were included. None of the patients had been under treatment with non-steroideal antiinflammatory drugs, proton-pump inhibitors or antimicrobial drugs in the two weeks prior to the bleeding event, and none had received eradicating therapy for H. pylori. In this group of selected patients an H. pylori infection rate nearing 100% was assumed. H. pylori infection was ruled out using antral biopsy (69 cases) or both antral and fundic biopsies (51 cases) for urease rapid testing (Jatrox-H.p.-Test). Patients were classified in three groups according to their endoscopic bleeding signs: a) presence of blood in the stomach or recent bleeding ulcer (21 cases); b) ulcer showing non-recent bleeding signs (38 cases); and c) ulcer without bleeding signs (61 cases). The sensitivity of the urease rapid test was compared between patient groups. Similarly, urease test results with an antral biopsy sample were compared in 100 patients with non-bleeding duodenal ulcer. Urease test was positive in 93% of patients with non-bleeding duodenal ulcer, and in 83% of patients with upper gastrointestinal bleeding, which reached statistical significance (p = 0.019). This test was positive in 82.6% of patients with an antral biopsy, and in 82.3% of patients with combined antral and fundic biopsies. In group A, urease test was positive in 90.5% of patients; in group B, it was positive in 89.5% of patients, and in group C, the test turned positive in 75.4% of patients. Statistical differences were only reached when patients in group C were compared to patients in groups A and B together (p = 0.037). 1. The presence of either blood in the stomach or recent bleeding endoscopic signs appeared not to be the conditioning factor for the decreased sensitivity of urease test among patients with bleeding duodenal ulcer. 2. The decreased sensitivity of this test in patients with upper gastrointestinal bleeding is more evident during the resolution stage, and it does not seem to occur because of H. pylori migration from the antrum to the corporal gastric region.
Castro Fernández M, Sánchez Muñoz D, García Díaz E, Galán
Jurado MV, Rodríguez Alonso C. Diagnosis of
Helicobacter py-
lori
infection using urease rapid test in patients with bleeding
duodenal ulcer: influence of endoscopic signs and simultaneous
corporal and antral biopsies. Rev Esp Enferm Dig 2004; 96:
599-605.
ABSTRACT
Introduction: the sensitivity of invasive diagnostic methods
for
Helicobacter pylori (H. pylori) infection, particularly of ure-
ase rapid test, is decreased in cases of gastroduodenal ulcer and
upper gastrointestinal bleeding.
Objectives: to assess the influence of blood in the stomach or
recent bleeding endoscopic signs in the diagnostic sensitivity of
urease rapid test among patients with bleeding duodenal ulcer, as
well as the influence of simultaneously collected corporal and
antral biopsy samples.
Patients and methods: 120 patients, 85 male and 35 fe-
male, with an average age of 62 (18-88) years, who were admit-
ted to our Hospital due to bleeding duodenal ulcer and who re-
ceived an endoscopic diagnosis within 24 hours of admission
were included. None of the patients had been under treatment
with non-steroideal antiinflammatory drugs, proton-pump in-
hibitors or antimicrobial drugs in the two weeks prior to the bleed
-
ing event, and none had received eradicating therapy for
H. py
-
lori
. In this group of selected patients an H. pylori infection rate
nearing 100% was assumed.
H. pylori infection was ruled out us-
ing antral biopsy (69 cases) or both antral and fundic biopsies (51
cases) for urease rapid testing (Jatrox®-H.p.-Test). Patients were
classified in three groups according to their endoscopic bleeding
signs: a) presence of blood in the stomach or recent bleeding ulcer
(21 cases); b) ulcer showing non-recent bleeding signs (38 cases);
and c) ulcer without bleeding signs (61 cases). The sensitivity of
the urease rapid test was compared between patient groups. Sim-
ilarly, urease test results with an antral biopsy sample were com-
pared in 100 patients with non-bleeding duodenal ulcer.
Results: urease test was positive in 93% of patients with non-
bleeding duodenal ulcer, and in 83% of patients with upper gas-
trointestinal bleeding, which reached statistical significance (p =
0.019). This test was positive in 82.6% of patients with an antral
biopsy, and in 82.3% of patients with combined antral and fundic
biopsies. In group A, urease test was positive in 90.5% of pa-
tients; in group B, it was positive in 89.5% of patients, and in
group C, the test turned positive in 75.4% of patients. Statistical
differences were only reached when patients in group C were
compared to patients in groups A and B together (p = 0.037).
Conclusions:
1. The presence of either blood in the stomach or recent
bleeding endoscopic signs appeared not to be the conditioning
factor for the decreased sensitivity of urease test among patients
with bleeding duodenal ulcer.
2. The decreased sensitivity of this test in patients with upper
gastrointestinal bleeding is more evident during the resolution
stage, and it does not seem to occur because of
H. pylori migra-
tion from the antrum to the corporal gastric region.
Key words: Helicobacter pylori. Urease test. H. pylori diagno-
sis. Bleeding duodenal ulcer.
INTRODUCTION
Helicobacter pylori (H. pylori) infection represents the
most frequent etiology of gastroduodenal ulcer. The preva
lence
of this infection in duodenal and gastric ulcer is about 85-
95% and 75-85%, respectively (1,2). Patients with gastro-
duodenal ulcer may develop complications such as upper
gastrointestinal bleeding or perforation, which calls for a
precise diagnosis of
H. pylori infection since eradication re-
duces significantly the risk of ulcer reactivation, and thus
prevents new episodes of upper gastrointestinal bleeding (3-5).
Several diagnostic methods for H. pylori infection are avail-
able, either invasive –which require endoscopy and gastric
biopsies (urease rapid test, histology and cultures)– or non-
Diagnosis of Helicobacter pylori infection using urease rapid test in
patients with bleeding duodenal ulcer: influence of endoscopic
signs and simultaneous corporal and antral biopsies
M. Castro Fernández, D. Sánchez Muñoz, E. García Díaz, M. V. Galán Jurado and C. Rodríguez Alonso
Service of Digestive Diseases. Hospital Universitario de Valme. Sevilla. Spain
1130-0108/2004/96/9/599-605
R
EVISTA ESPAÑOLA DE ENFERMEDADES DIGESTIVAS
Copyright © 2004
A
RÁN EDICIONES, S. L
.
REV ESP ENFERM DIG (Madrid)
Vol. 96. N.
° 9, pp. 599-605, 2004
Recibido: 16-10-03.
Aceptado: 27-01-04.
Correspondencia: Manuel Castro Fernández. Servicio de Aparato Digesti-
vo (9ª planta izda.). Hospital Universitario de Valme. Ctra. de Cádiz, s/n.
41014 Sevilla. e-mail: mcastrof@meditex.es
ORIGINAL PAPERS
invasive (urea C
13
breath test, stool antigen detection and
serology), all of them exhibiting both advantages and disad-
vantages regarding availability, rapidity of results, value,
and diagnostic accuracy (6-9). Invasive methods, specially
the urease rapid test, show decreased sensitivity in cases of
bleeding gastroduodenal ulcers (6-7,10-14).
The causes of this decreased sensitivity are not yet estab-
lished, and various factors such as therapy with proton
pump inhibitors (PPI) or the presence of blood in the stom-
ach have been implicated.
The aims of this study were to establish the influence of
the presence of blood in the stomach or bleeding endoscopic
signs, as well as of simultaneous antral and fundic biopsy
collection, in the diagnostic sensitivity of urease test in pa-
tients with bleeding duodenal ulcer.
PATIENTS AND METHODS
Patients
We included 120 patients (85 males and 35 females) with
an mean age of 62 years (18-88 years) who were admitted to
our hospital with bleeding duodenal ulcer and who under-
went upper gastrointestinal endoscopy within 24 hours after
admission. They had not been under treatment with non-
steroideal anti-inflammatory drugs (NSAID), PPIs or antibi-
otics for the two weeks prior to the bleeding event, and they
had not received eradicating therapy for H. pylori either;
these data were revealed in a directed interview. In this select-
ed group of patients, a H. pylori infection rate of almost 100%
was assumed. Intravenous omeprazole was given to all pa-
tients before endoscopy for a period shorter than 24 hours, us-
ing a variable dosage between 40 and 160 mg.
We also studied a second group of 100 patients (87 males
and 13 females), aged 55 years (20-77 years), with duodenal
ulcer and dyspepsia, without gastrointestinal bleeding, diag-
nosed endoscopically, and with no prior intake of either
NSAID or H. pylori eradicating therapy.
Informed consent in writing was obtained from each pa-
tient before gastroscopy.
Diagnostic methods
Patients with bleeding duodenal ulcer were investigated
for H. pylori infection using either antral biopsies (69 cases)
or both antral and fundic biopsies (51 cases) for urease rapid
testing (Jatrox
®
-H.p.-Test). The decision to take additional
fundic biopsies was not conditioned by the endoscopic diag-
nosis. The test was considered positive when the color
turned from yellow to red within 24 hours following the in-
clusion of biopsy specimen into a reagent-containing cu-
vette with 0.5 ml of distilled water. Patients were distributed
in three groups according to the endoscopic findings: a)
presence of blood in the stomach or signs of recent (direct)
bleeding (active hemorrhage, visible vessel or adherent clot)
(n = 21); b) presence of signs of non-recent (indirect) bleed-
ing (black points or spot) (n = 38); and c) absence of bleed-
ing signs (ulcer with fibrin base) (n = 61). In patients with
non-bleeding duodenal ulcer only antral biopsies were taken
for urease testing.
Statistical study
Statistical significance of differences between groups of
patients was analyzed using the Chi-square, Fisher’s exact,
and McNemar tests. We considered the results to be statisti-
cally significant when p < 0.05. Confidence intervals at 95%
were also calculated.
RESULTS
Urease test was positive in 99 out of 120 patients (83%)
with bleeding duodenal ulcer, and in 93 out of 100 patients
(93%) with non-bleeding duodenal ulcer. This difference
was statistically significant (p = 0.019; OR: 0.35; CI 95%
[0.13-0.93]).
Sex and age distribution was similar in both groups.
In the group of patients where only antral biopsies were
taken (n = 69), the urease test was positive in 57 cases
(82.6%), whereas, in the group of patients in which both
antral and fundic biopsies were taken (n = 51), the test was
positive in 42 cases (82.3%). This difference was not statis-
tically significant (p = 0.97; OR: 1.01; CI 95% [0.35-2.89]).
Table I shows the sensitivity of the urease test according
to the site where the gastric biopsies were taken or the pres-
ence of endoscopic signs of bleeding. These differences
were not significant when comparing the three groups of pa-
tients with bleeding duodenal ulcer together. Nevertheless, a
significant association was found when comparing group C
(absence of bleeding signs) with groups A and B together
(presence of bleeding signs); [p = 0.037: OR: 2.88; CI 95%
(0.94-9.14)] (Table II).
Table I. Results of the rapid urease test according to gastric
biopsy site and presence of endoscopic signs of bleeding (*)
Group Gastric biopsy site Urease test (+) Urease test (-) Sensitivity
(nº: 99) (nº: 21) (%) (**)
A (nº 21)
Antral (nº 12)
11 1 91.6 (90.5)
Fundic-Antral (nº 9) 8 1 88.8
B (nº 38) Antral (nº 18) 16 2 88.8 (89.5)
Fundic-Antral (nº 20) 18 2 90.0
C (nº 61) Antral (nº 39) 30 9 76.9 (75.4)
Fundic-Antral (nº 22) 16 6 72.7
(*): Differences without statistical significance (p > 0.05)
(**): Mean sensitivity for each group shown in brackets
A:
Blood in stomach or recent signs of bleeding: active hemorrhage, visible vessel
or adherent clot
B: Non-recent signs of bleeding: black points or spot in ulcer area
C: Absence of bleeding signs: ulcer with fibrin base
600 M. CASTRO FERNÁNDEZ ET AL.
R
EV ESP ENFERM DIG (Madrid)
REV ESP ENFERM DIG 2004; 96(9): 599-605
Table II. Results of urease test in patients with (group A + B)
or without (group C) endoscopic signs of bleeding (*)
Group No. of cases Urease test Urease test Sensitivity
(+) (-) (%)
A + B 59 53 6 89.8
C 61 46 15 75.4
(*) Differences reaching statistical significance (p = 0.0376; OR 2.88; CI 95%
[0.94-9.14]
DISCUSSION
The prevalence of H. pylori infection in gastroduodenal
ulcer is high (75-85% in gastric ulcers; 85-95% in duodenal
ulcers) (1,2). This prevalence is similar, or just slightly low-
er, in bleeding gastroduodenal ulcers because of the influ-
ence of NSAID intake (15). The urease rapid test can be
considered the diagnostic method of choice in these patients
requering endoscopy, because of its simplicity, diagnostic
accuracy and rapidity of results (18,19), although decreased
sensitivity has been reported in cases of bleeding duodenal
ulcer (6,11,13,20-22). In such cases, histology, simultane-
ous urease test and histology, or C
13
breath test after a hem-
orrhagic event (with no invasive test being performed) have
been proposed by some authors (7,10).
The cause for this decreased diagnostic sensitivity of the
urease test in cases of bleeding duodenal ulcer remains con-
troversial. Several circumstances have been considered to
explain this fact, such as the presence of blood in the stom-
ach, which might induce a transient mucosal bacterial clear-
ance because of a bactericide effect of the serum (7,25). An-
other possibility is that serum albumin may induce a
buffering effect on the pH indicator used for urease testing,
which might prevent color change (26). The common use of
PPI by these patients may also reduce the mucosal bacterial
load, resulting in bacterial migration to the upper regions of
the stomach (6).
However, “in vitro” studies, such as those performed by
Perry et al. (27), failed to demonstrate that the presence of
blood in the stomach reduces the sensitivity of the rapid ure
ase
test, while some other “in vitro” studies find this decreasing
as a late effect of the bleeding (28). These results are consis-
tent with those obtained in the present study. However,
some other authors do not find differences between bleeding
and non-bleeding ulcers, neither in sensitivity nor in speci-
ficity of the rapid urease test. However, a decreased sensi-
tivity of this test when it is performed under the influence of
blood in the stomach has been reported (29).
Patients with bleeding duodenal ulcer without the influ
-
ence of NSAIDs, antibiotics or eradicating drugs for
H. py-
lori infection were included in the present study. In this
group of patients, a H. pylori infection rate of near 100%, as
it is well defined in some studies (15-17) (and personally
observed in our hospital), can be assumed. This fact allows
the rate of rapid urease test false negative results to be as-
sessed without the exclusion of patients with non-confirmed
negative results (using other diagnostic methods) for the ab-
sence or presence of H. pylori infection. Nevertheless, it is
not advisable to routinely assume, without additional inves-
tigation, that all patients with gastroduodenal ulcer and no
previous history of NSAID ingestion are infected with
H.
pylori.
In patients with blood in the stomach or endoscopic signs
of bleeding ulcer (either recent or not), the sensitivity of the
urease test is almost 90%, and this rate is higher than that
found in patients without endoscopic signs of bleeding
(75.4%). This situation could be explained by the possibility
of a late effect of blood on the decreased sensitivity of the
urease test, which concur with the results obtained by other
studies (26). It is not possible to assess the influence of in-
travenous omeprazole in each group of patients. However,
none of the patients included in our study received this ther-
apy for more than 24 hours. Urease test was positive in 93%
of patients with non-bleeding duodenal ulcer. This rate of
positivity is higher than that observed in patients with bleed-
ing duodenal ulcer, in whom we found a 75.4% of positive
results.
In our opinion, according to the results of the present
study, the presence of blood in the stomach or of endoscopic
signs of bleeding at the time of biopsy does not represent a
conditioning factor for decreased sensitivity of the urease
test. Likewise, this decreased sensitivity does not seem to be
due to the migration of the H. pylori to the fundic region of
the stomach. The reduced sensitivity of this test may be a
late, neither immediate nor early, phenomenon in upper gas-
trointestinal bleeding.
The presence or absence of blood or endoscopic signs of
bleeding at the time of biopsy should not be the factor deter-
mining an investigation of H. pylori infection by using the
urease test. The lower sensitivity of the urease test in pa-
tients with upper gastrointestinal bleeding may not be a fac-
tor for turning urease testing down, since a precise and early
diagnosis of H. pylori infection is established in a high pro-
portion of such patients (83%). Nevertheless, controlled
studies are necessary to define which diagnostic method (or
combination thereof) is better for the diagnosis of H. pylori
infection in patients with bleeding gastroduodenal ulcer.
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° 9, 2004 DIAGNOSIS OF
HELICOBACTER PYLORI INFECTION USING UREASE RAPID TEST IN PATIENTS 601
WITH BLEEDING DUODENAL ULCER
REV ESP ENFERM DIG 2004; 96(9): 599-605
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REV ESP ENFERM DIG 2004; 96(9): 599-605
Diagnóstico de la infección por Helicobacter pylori mediante el test
rápido de la ureasa en pacientes con hemorragia por úlcera
duodenal: influencia de los signos endoscópicos de sangrado y de
la obtención simultánea de biopsias de cuerpo y antro gástrico
M. Castro Fernández, D. Sánchez Muñoz, E. García Díaz, M. V. Galán Jurado y C. Rodríguez Alonso
Servicio de Aparato Digestivo. Hospital Universitario de Valme. Sevilla
RESUMEN
Introducción: la sensibilidad de los métodos diagnósticos in-
vasivos de infección por
H. pylori, especialmente el test rápido de
la ureasa, disminuye en los casos de úlcera gastro-duodenal y he
-
morragia digestiva.
Objetivos: valorar la influencia de la presencia de sangre en
estómago o de signos endoscópicos de sangrado en la sensibilidad
del test rápido de la ureasa en pacientes con hemorragia por úlce
-
ra duodenal, así como la influencia de la obtención de biopsias de
cuerpo y antro gástrico.
Pacientes y métodos: incluimos 120 pacientes, 85 varones
y 35 mujeres, con edad media de 62 (18-88) años, con hemorra-
gia por úlcera duodenal y diagnóstico endoscópico en las primeras
24 horas del ingreso. Ningún paciente había consumido antiinfla-
matorios no esteroideos, inhibidores de la bomba de protones o
antibióticos en las dos semanas previas a la hemorragia digestiva,
ni había recibido tratamiento frente a
H. pylori. En este grupo se-
leccionado de pacientes admitimos una tasa de infección de prác-
ticamente el 100%. Investigamos la infección por
H. pylori me-
diante biopsias de antro (69 casos) o de cuerpo y antro (51 casos)
gástricos para test de ureasa. Los pacientes se clasificaron en tres
grupos según los signos de sangrado: a) sangre en estómago o úl-
cera con signos recientes de sangrado (21 casos); b) úlcera con
signos no recientes de sangrado (38 casos); y c) úlcera sin signos
de sangrado (61 casos). Comparamos la sensibilidad del test rápi
-
do de ureasa en los distintos grupos de pacientes. Estudiamos asi-
mismo los resultados del test de la ureasa, mediante biopsia antral,
en 100 pacientes con úlcera duodenal sin hemorragia digestiva.
Resultados: el test de la ureasa resultó positivo en el 93%
(93/100) de los pacientes con úlcera duodenal sin hemorragia di-
gestiva y en el 83% (99/120) de los pacientes con hemorragia di-
gestiva, siendo la diferencia estadísticamente significativa
(p=0,019). Mediante biopsia antral resultó positivo en el 82,6%
(57/69) y mediante biopsias de antro y cuerpo gástrico en el
82,3% (42/51) de los casos. En el grupo A el test de ureasa fue
positivo en el 90,5% (19/21); en el grupo B en el 89,5% (34/38)
y en el grupo C en el 75,4% (46/61) de los casos, detectándose
únicamente diferencias con significado estadístico al comparar el
grupo C (nº 61) con los grupos A y B asociados (nº 59)
(p=0,037).
Conclusiones:
1. La presencia de sangre en estómago o de signos recientes
de sangrado, en el momento de la endoscopia, no parecen ser el
factor condicionante de la disminución de sensibilidad del test de
ureasa en pacientes con hemorragia digestiva por úlcera duode-
nal.
2. La disminución de la sensibilidad del test rápido de la urea-
sa, en el contexto de la hemorragia digestiva, no sería un suceso
inmediato o precoz, siendo más evidente en el estadio de resolu-
ción de la hemorragia digestiva y no parece ocasionado por la
emigración de
H. pylori del antro al cuerpo gástrico.
Palabras clave: Helicobacter pylori. Test de ureasa. Diagnósti-
co de
H. pylori. Úlcera duodenal sangrante.
INTRODUCCIÓN
La infección por Helicobacter pylori (H. pylori) es la
causa más frecuente de la enfermedad ulcerosa gastroduode-
nal. La prevalencia de esta infección en las úlceras duodena-
les y gástricas es aproximadamente del 85-95 y 75-85% res-
pectivamente (1,2). Los pacientes con enfermedad ulcerosa
gastroduodenal pueden presentar complicaciones, como he-
morragia digestiva o la perforación y es necesario realizar
un diagnóstico preciso de la infección por
H. pylori, ya que
su erradicación reduce considerablemente la posibilidad de
recidiva ulcerosa y de nuevos episodios de hemorragia di-
gestiva (3-5). Disponemos de varios métodos diagnósticos
de infección por
H. pylori, bien invasivos, que precisan la
práctica de gastroscopia y biopsias gástricas (test rápido de
la ureasa, histología y cultivo) o no invasivos (test del alien
-
to con urea
13
C, detección de antígenos en heces y serolo
-
gía), presentando todos ellos ventajas e inconvenientes, en
relación a disponibilidad, rapidez en resultados, coste o pre-
cisión diagnóstica (6-9). Los métodos invasivos, especial
-
mente el test rápido de la ureasa, muestra una pérdida de
sensibilidad en los casos de úlcera gastroduodenal compli
-
cada con hemorragia digestiva (6-7,10-14).
No están aclaradas las causas que motivan el descenso de
la sensibilidad diagnóstica del test de ureasa, habiéndose
implicado factores como el tratamiento con inhibidores de la
bomba de protones (IBP) o la presencia de sangre en el estó-
mago.
El objetivo de este estudio es valorar la influencia de la
presencia de sangre en cavidad gástrica o signos endoscópi-
cos de sangrado, así como de la obtención de biopsias de
cuerpo y antro, en la sensibilidad diagnóstica del test de
ureasa en pacientes con úlcera duodenal y hemorragia di-
gestiva.
PACIENTES Y MÉTODOS
Pacientes
Se incluyen 120 pacientes consecutivos (85 varones y 35
mujeres) con edad media de 62 años (18-88) que ingresaron
con hemorragia digestiva por úlcera duodenal, con diagnós-
tico endoscópico en las primeras 24 horas del ingreso, e in-
vestigación mediante el test de la ureasa de infección por
H.
pylori. No se incluyeron pacientes que habían consumido
antiinflamatorios no esteroideos (AINE), IBP o antibióticos
en las dos semanas previas al ingreso o habían recibido tra-
tamiento para H. pylori, siendo estos datos recogidos me-
diante interrogatorio dirigido. En este grupo seleccionado de
pacientes admitimos una tasa de infección por H. pylori de
prácticamente el 100%. En todos los casos se había iniciado,
antes de la práctica de la endoscopia oral, tratamiento con
omeprazol i.v., durante un periodo no superior a 24 horas,
con dosis oscilantes entre 40 y 160 mg.
Estudiamos asimismo un grupo de 100 pacientes ambula-
torios (87 varones y 13 mujeres) con úlcera duodenal sin he-
morragia digestiva y edad media de 55 años (20-77), con o
sin tratamiento con IBP, diagnosticados mediante endosco-
pia oral, que no referían consumo de AINE en las dos sema-
nas previas, ni habían recibido tratamiento erradicador de H.
pylori.
En todos los pacientes, antes de la práctica de la endosco-
pia oral, se solicitó un consentimiento informado.
Métodos diagnósticos
En los pacientes con úlcera duodenal y hemorragia diges
-
tiva se investigó la infección por H. pylori mediante la ob-
tención de biopsias de antro (69 casos) o bien de antro y
cuerpo gástrico (51 casos), para realizar el test rápido de la
ureasa (Jatrox
®
-H.p.-Test). La decisión personal de los en-
doscopistas de obtener biopsias adicionales de cuerpo gás-
trico no estaba condicionada por el diagnóstico endoscópi
-
co. El test se consideró positivo cuando se producía el viraje
de color (de amarillo a rojo) en las primeras 24 horas tras in-
troducir las muestras de biopsia en un pocillo con el reactivo
y 0,5 ml de agua destilada. Los pacientes se clasificaron en
tres grupos según los hallazgos endoscópicos: a) presencia
de sangre en estómago o signos recientes (directos) de san
-
grado en la lesión ulcerosa (hemorragia activa, vaso visible
Vol. 96. N.
° 9, 2004 DIAGNÓSTICO DE LA INFECCIÓN POR
HELICOBACTER PYLORI MEDIANTE EL TEST RÁPIDO DE LA UREASA 603
EN PACIENTES CON HEMORRAGIA POR ÚLCERA DUODENAL
REV ESP ENFERM DIG 2004; 96(9): 599-605
o coágulo adherido) (nª 21); b) presencia de signos no re-
cientes (indirectos) de sangrado en la lesión ulcerosa (pun-
tos o mancha negra) (nº 38); y c) ausencia de signos de san-
grado (lesión ulcerosa con fondo fibrinado) (nº 61). En los
pacientes con úlcera duodenal, sin hemorragia digestiva, el
test de la ureasa se realizó con biopsias únicamente de antro
gástrico.
Estudio estadístico
La significación estadística de las diferencias encontradas
entre los distintos grupos evaluados fue estudiada aplicando
las pruebas de Chi-cuadrado, exacto de Fisher y test de Mc-
Nemar. Consideramos los resultados como estadísticamente
significativos cuando obteníamos una p < 0,05. Se calcula-
ron los intervalos de confianza al 95%.
RESULTADOS
El test de ureasa resultó positivo en 99 de los 120 pacien-
tes (83%) con úlcera duodenal y hemorragia digestiva, y en
93 de los 100 pacientes (93%) con úlcera duodenal sin he-
morragia digestiva, siendo la diferencia estadísticamente
significativa (p=0,019; OR: 0,35; IC95% [0,13-0,93]).
La distribución por sexos y edades en ambos grupos de
pacientes resultó similar.
En los pacientes donde se obtuvieron sólo biopsias antra-
les (n=69) el test de ureasa fue positivo en 57 casos (82,6%),
mientras que en aquellos donde se obtuvieron biopsias de
antro y cuerpo gástricos (n=51) fue positivo en 42 casos
(82,3 %), diferencia sin significado estadístico (p=0,97; OR:
1,01; IC95%[0,35-2,89]).
En la tabla I se recogen los resultados y sensibilidad del
test de la ureasa según la localización de las biopsias gástri-
cas y presencia de signos endoscópicos de sangrado. Las di-
ferencias no alcanzaron significación estadística al compa-
rar entre sí los tres grupos de pacientes con úlcera duodenal
y hemorragia digestiva. Existía significación estadística al
comparar el grupo C (ausencia de signos de sangrado) con el
grupo A y B asociados (presencia de signos de sangrado) (p
=0.037:= OR.:2.88; IC95% [0.94-9.14]) (Tabla II).
Tabla II. Resultados del test de la ureasa en los pacientes
con signos (grupo A+ B) y sin signos endoscópicos de san-
grado (grupo C) (*)
Grupo Nº casos TUR TUR Sensibilidad
(+) (-) (%)
A + B 59 53 6 89,8
C 61 46 15 75,4
(*) Diferencias con significación estadística (p = 0,0376; OR 2,88; CI 95% [0,94-
9,14]
DISCUSIÓN
La prevalencia de la infección por H. pylori en la enfer-
medad ulcerosa gastroduodenal es muy elevada, 75-85% en
las úlceras gástricas y 85-95% en las úlceras duodenales.
(1,2), La prevalencia es similar o levemente inferior, por
mayor influencia de los AINE en las úlceras gastroduodena-
les con hemorragia digestiva (15). El test rápido de la urea-
sa, en estos pacientes que requieren endoscopia, se puede
considerar como el método diagnóstico de elección, por su
sencillez, precisión y rapidez del resultado (18,19), aunque
presenta una disminución de la sensibilidad diagnóstica en
los casos de úlcera gastroduodenal con hemorragia digestiva
(6,11,13,20-22). En estos casos se ha recomendado por al-
gunos autores practicar histología, con menor pérdida de
sensibilidad (23), en vez del test de la ureasa, practicar si-
multáneamente test de ureasa e histología, o no practicar
ningún test invasivo y realizar el test del aliento con
13
C tras
superarse el episodio hemorrágico (7,10).
La causa de la disminución de la sensibilidad diagnóstica
del test de ureasa en la úlcera gastroduodenal sangrante si-
gue siendo motivo de controversia, considerándose diversas
circunstancias, tales como la presencia de sangre en la cavi
-
dad gástrica, que podría inducir un aclaramiento transitorio
de la densidad bacteriana en la mucosa por un efecto bacte-
ricida del suero (7,25), o que la seroalbúmina del suero san
-
guíneo provocaría un efecto tampón sobre el indicador de
pH empleado en el test de ureasa que impediría el viraje de
coloración (26), o bien el uso frecuente de IBP en estos pa-
cientes que también reduciría la carga bacteriana de la mu-
cosa o condicionarían la migración de las bacterias al cuerpo
gástrico (6).
No obstante, trabajos “in vitro” como el de Perry y cols.
(27), no han podido demostrar que la presencia de sangre
produzca una disminución de sensibilidad del test rápido de
ureasa, y otros trabajos, también “in vitro”, sólo lo ponen de
manifiesto de forma tardía (28), lo cual avalarían los resulta
-
dos obtenidos en el presente trabajo. Otros autores, sin em-
bargo, no encuentran diferencias en la sensibilidad ni espe
-
604 M. CASTRO FERNÁNDEZ ET AL.
R
EV ESP ENFERM DIG (Madrid)
REV ESP ENFERM DIG 2004; 96(9): 599-605
Tabla I. Resultados del test rápido de la ureasa según el lu-
gar de la obtención de las biopsias gástricas y la presencia
de signos endoscópicos de sangrado (*)
Grupo Localización de las TUR (+) TUR (-) Sensibilidad
biopsias gástricas
(nº: 99) (nº: 21) (%) (**)
A (nº 21) Antro (nº 12) 11 1 91,6 (90,5)
Cuerpo-Antro (nº 9)
8
1
88,8
B (nº 38) Antro (nº 18) 16 2 88,8 (89,5)
Cuerpo-Antro (nº 20) 18 2 90,0
C (nº 61) Antro (nº 39) 30 9 76,9 (75,4)
Cuerpo-Antro (nº 22)
16
6
72,7
(*): Diferencias sin significado estadístico (p>0,05)
(**): En paréntesis la sensibilidad media de cada grupo
A:
Sangre en estómago o signos recientes de sangrado: hemorragia activa, vaso
visible o coágulo adherido
B: Signos no recientes de sangrado: mancha o puntos negros en la lesión ulcero-
sa.
C: Ausencia de signos de sangrado: base ulcerosa limpia
TUR (+): Test rápido de la ureasa positivo
TUR (-): Test rápido de la ureasa negativo
cificidad del test rápido de ureasa cuando lo realizan en pa-
cientes con úlceras sangrantes y úlceras no sangrantes, pero
sí constatan un descenso de sensibilidad del citado test cuan-
do se practica con presencia de sangre en estómago (29).
En este estudio hemos incluido pacientes con úlcera duo-
denal sangrante no expuestos a AINE, antibióticos, y sin tra
-
tamiento erradicador previo para
H. pylori, de forma que en
esta situación podemos admitir una tasa de infección H. py-
lori de prácticamente el 100%, como se señala en otros estu-
dios (15-17) y como hemos observado personalmente en
nuestro medio hospitalario. Esto permite valorar la tasa de
falsos negativos del test rápido de ureasa sin el sesgo que se
origina al excluirse pacientes con test de ureasa negativo sin
confirmación, por otros métodos, de la ausencia o presencia
de infección por
H. pylori. Esto no implica que, en la prácti-
ca clínica y de forma rutinaria, debamos asumir sin la inves-
tigación pertinente que todos los pacientes con enfermedad
ulcerosa gastroduodenal, sin consumo de AINE, están infec-
tados por H. pylori.
En los pacientes con sangre en estómago o signos endos-
cópicos de sangrado en la lesión ulcerosa (recientes y no re-
cientes) observamos una sensibilidad aproximadamente del
90%, superior a la observada en los pacientes que no tenían
signos endoscópicos de sangrado (75,4%) . Esta situación se
podría explicar considerando que el posible efecto que pu-
diera ejercer la sangre disminuyendo la sensibilidad del test
de ureasa tendría lugar de forma diferida, es decir, no de una
manera inmediata o precoz, apoyando los resultados de
otros estudios en este sentido (28). No podemos valorar la
influencia, en cada grupo de pacientes, del tratamiento con
omeprazol intravenoso, aunque en ningún caso tuvo una du-
ración superior a 24 horas. El test de la ureasa resultó positi-
vo en el 93% de los pacientes con úlcera duodenal sin hemo-
rragia digestiva, porcentaje superior al observado en
pacientes con úlcera duodenal con hemorragia digestiva sin
signos de sangrado que resultó del 75,4%.
Opinamos, en base a nuestros resultados, que la presencia
de sangre en estómago o signos endoscópicos de sangrado
en el momento de obtención de las biopsias no es el factor
condicionante de la pérdida de sensibilidad del test de la
ureasa y tampoco parece originarse por la migración de
H.
pylori
hacia cuerpo gástrico. La disminución de sensibilidad
del test de ureasa sería un fenómeno tardío, no inmediato o
precoz, en la evolución de la hemorragia digestiva.
La presencia o ausencia de sangre o de signos endoscó-
picos de sangrado en el momento de la endoscopia no debe
ser el factor que condicione la decisión de investigar me-
diante el test de la ureasa la infección por
H. pylori. La dis-
minución de la sensibilidad del test de la ureasa en pacien-
tes con hemorragia digestiva no justificaría, en nuestra
opinión, que esta prueba sea rechazada, ya que en un por-
centaje alto de pacientes (83%) nos aseguraríamos un diag-
nóstico precoz y preciso de la infección por H. pylori. En
cualquier caso, son necesarios nuevos estudios que puedan
determinar qué método o combinación de métodos diag-
nósticos de infección por H. pylori resulta más fiable en
pacientes con úlcera gastroduodenal complicada con he-
morragia digestiva.
Vol. 96. N.
° 9, 2004 DIAGNÓSTICO DE LA INFECCIÓN POR
HELICOBACTER PYLORI MEDIANTE EL TEST RÁPIDO DE LA UREASA 605
EN PACIENTES CON HEMORRAGIA POR ÚLCERA DUODENAL
REV ESP ENFERM DIG 2004; 96(9): 599-605
... However, increasing the number of biopsy samples can increase the sensitivity of this test.10,21 Castro Fernández M et al.,22 reported that among nonbleeding duodenal ulcer patients RUT sensitivity was 93%, whereas, among patients with bleeding, it is 83%. The difference was reported to be statistically significant. ...
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Background and Aim The presence of blood in the stomach has been thought to affect the performance of diagnostic tests used in detecting Helicobacter pylori (H. pylori) in the stomach. This study evaluates the effect of upper gastrointestinal bleeding on the efficacy of a rapid urease test (RUT) and compares the results with the pathologic method. Methods In this descriptive study, 100 patients presented with upper gastrointestinal bleeding, confirmed from endoscopy, referred to Shahid Rahimi Hospital in Khorramabad were enrolled. Antral biopsy was performed in all the patients and the samples were extracted for histopathology and RUT. A questionnaire was used to collect rapid urease test outcomes and associated parameters (antibiotic, bismuth, and proton pump inhibitors), histology and demographic data. Histopathology was used as the gold standard for diagnosis of H. pylori. Results Of the 52 patients who were reported positive for H. pylori in pathology, 36 had RUT‐positive H. pylori, sensitivity 69.2%, and of 48 patients whose pathology was negative, 25 had negative RUT, specificity 52.1%. Of 59 RUT, 36 had positive pathology, positive predictive value was 61% and from 41 with negative RUT, 25 had negative pathology, negative predictive value was 61%. The prevalence of H. pylori infection was significantly associated with the age of 50 years and above, p = 0.042, and previous history of bleeding, p = 0.019. Conclusion Gastrointestinal bleeding can reduce the sensitivity of RUT. The negative results of these tests in acute upper gastrointestinal bleeding should therefore be interpreted carefully.
... The effect of presence of blood in the stomach on sensitivity and specificity of RUT is controversial. This issue was addressed by Fernandez et al. who concluded the presence of blood in the stomach or recent stigmata of bleeding was not a conditioning factor for the decreased diagnostic sensitivity of RUT in patients with bleeding duodenal ulcer [31]. However, other study showed decreased sensitivity of RUT in patients with bleeding ulcers [32]. ...
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Background Increasing resistance against Helicobacter py-lori has resulted in reduced eradication rates. Objective This study aims to determine whether eradication rates for H. pylori infection with sequential therapy is better than standard triple therapy. Patients Patients with endoscopy documented peptic ulcer and H. pylori infection confirmed by histology and rapid urease test. Intervention Patients were randomized into two groups; 134 received standard triple therapy (pantoprazole 40 mg, clar-ithromycin 500 mg and amoxicillin 1 g each administered twice daily) for 10 days and 138 received sequential regi-men (pantoprazole 40 mg plus amoxicillin 1 g twice daily for 5 days followed by 40 mg pantoprazole, 500 mg clari-thromycin, and 500 mg tinidazole each administered twice daily for 5 days). Eradication was confirmed by histology and rapid urease test. Compliance and adverse effects were determined by the recovery of empty medicine strips and questioning. Results The eradication rates with sequential therapy were significantly greater than with standard therapy on both intention-to-treat analysis (76.0 % vs. 61.9 %, p=0.005; difference, 14.1 % [95 % CI, 6.5-19 %] and per protocol analysis (84.6 % vs. 67.4 %, p=0.002; difference, 17.2 % [95 % CI, 8.5-23.5 %]). The incidence of side effects did not differ between the two therapy groups. One patient in standard therapy discontinued treatment due to side effects. Limitation Cultures were not performed. Loss to follow up was 5.2 % in standard therapy and 6.5 % in sequential therapy. Conclusion Sequential therapy was significantly more effective than standard therapy for eradicating H. pylori infection in peptic ulcer disease in Asian patients. Side effects were similar.
... The effect of presence of blood in the stomach on sensitivity and specificity of RUT is controversial. This issue was addressed by Fernandez et al. who concluded the presence of blood in the stomach or recent stigmata of bleeding was not a conditioning factor for the decreased diagnostic sensitivity of RUT in patients with bleeding duodenal ulcer [31]. However, other study showed decreased sensitivity of RUT in patients with bleeding ulcers [32]. ...
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... The identification of uninfected persons from cases of negative test results (NPV) by the RUT was 90.65% and by the Giemsa staining was 98.74%. Several studies have found that medications such as antibiotics, bismuth, or proton Pump Inhibitors (PPI) can reduce the density and/or urease activity of H. pylori, thereby decrease the sensitivity of the RUT (Fernandez MC et al., 2004 andGoddard AF et al., 2003). Acute ulcer bleeding at the time of testing may also decrease the sensitivity and negative predictive value of the RUT. ...
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Helicobacter pylori (H. pylori) remains a prevalent chronic infection in the developing countries. H.pylori is an important agent associated with peptic ulcer disease, chronic gastritis and gastric malignancies. It can be detected by various invasive (rapid urease test and histology) and non-invasive tests (stool antigen test, urea breath test and serology). The aim of this study was to compare the performance of the Rapid Urease Test (RUT) with histological Giemsa staining technique. Data was collected from histopathology reports of antral biopsies, endoscopy and RUT reports of the patients (n=429) who underwent endoscopic examination at a tertiary care private Hospital from July 2013 to May 2014. The overall positivity for H. pylori was considered when either or both tests were positive. H.pylori were found in 183 (42.65%) patients by the RUT method and in 191(44.55%) patients with the Giemsa staining technique. Only 18 (4.19%) cases showed dis-concordant results between Giemsa staining and the RUT method. With 95% confidence interval, proportion of the dis-concordant result (18/429) of two identification techniques is not statistically significant (p-value=1.00). Sensitivity and specificity of the Giemsa staining method was 98.45% & 100% and the RUT was 88.14%, 94.89% respectively. Even though no statistical significance was found for dis-concordant results by both methods, substitution of the RUT test by the histopathology Giemsa staining technique should be considered with caution. Keywords— Helicobacter pylori, Rapid Urease Test
... Sin embargo, los datos encontrados en este estudio contrastan con los reportados en humanos y caninos, en los cuales la mayor frecuencia de presentación se dio a nivel de antro pilórico y menor a nivel de fúndus (17,(32)(33)(34). También contrasta con resultados encontrados en humanos, en los cuales la mayor frecuencia de presentación de bacterias tipo Helicobacter spp., ha sido encontrada en la mucosa antral (18,35). Este contraste, entre los datos encontrados en equinos y los encontrados en humanos y caninos, podría deberse a que en el caballo existe una condición fisiológica importante, como es el reflujo duodenogástrico, el cual aumentaría parcialmente el pH a nivel de antro pilórico por su carácter alcalino, cambiando las condiciones de sobrevida de la bacteria, por lo que éstas migrarían hacia otros sitios de mayor acidez, como es el fundus gástrico (36,37). ...
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Background: Helicobacter pylori (H pylori) infection has been implicated in a number of malignancies and non-malignant conditions including peptic ulcers, non-ulcer dyspepsia, recurrent peptic ulcer bleeding, unexplained iron deficiency anaemia, idiopathic thrombocytopaenia purpura, and colorectal adenomas. The confirmatory diagnosis of H pylori is by endoscopic biopsy, followed by histopathological examination using haemotoxylin and eosin (H & E) stain or special stains such as Giemsa stain and Warthin-Starry stain. Special stains are more accurate than H & E stain. There is significant uncertainty about the diagnostic accuracy of non-invasive tests for diagnosis of H pylori. Objectives: To compare the diagnostic accuracy of urea breath test, serology, and stool antigen test, used alone or in combination, for diagnosis of H pylori infection in symptomatic and asymptomatic people, so that eradication therapy for H pylori can be started. Search methods: We searched MEDLINE, Embase, the Science Citation Index and the National Institute for Health Research Health Technology Assessment Database on 4 March 2016. We screened references in the included studies to identify additional studies. We also conducted citation searches of relevant studies, most recently on 4 December 2016. We did not restrict studies by language or publication status, or whether data were collected prospectively or retrospectively. Selection criteria: We included diagnostic accuracy studies that evaluated at least one of the index tests (urea breath test using isotopes such as13C or14C, serology and stool antigen test) against the reference standard (histopathological examination using H & E stain, special stains or immunohistochemical stain) in people suspected of having H pylori infection. Data collection and analysis: Two review authors independently screened the references to identify relevant studies and independently extracted data. We assessed the methodological quality of studies using the QUADAS-2 tool. We performed meta-analysis by using the hierarchical summary receiver operating characteristic (HSROC) model to estimate and compare SROC curves. Where appropriate, we used bivariate or univariate logistic regression models to estimate summary sensitivities and specificities. Main results: We included 101 studies involving 11,003 participants, of which 5839 participants (53.1%) had H pylori infection. The prevalence of H pylori infection in the studies ranged from 15.2% to 94.7%, with a median prevalence of 53.7% (interquartile range 42.0% to 66.5%). Most of the studies (57%) included participants with dyspepsia and 53 studies excluded participants who recently had proton pump inhibitors or antibiotics.There was at least an unclear risk of bias or unclear applicability concern for each study.Of the 101 studies, 15 compared the accuracy of two index tests and two studies compared the accuracy of three index tests. Thirty-four studies (4242 participants) evaluated serology; 29 studies (2988 participants) evaluated stool antigen test; 34 studies (3139 participants) evaluated urea breath test-13C; 21 studies (1810 participants) evaluated urea breath test-14C; and two studies (127 participants) evaluated urea breath test but did not report the isotope used. The thresholds used to define test positivity and the staining techniques used for histopathological examination (reference standard) varied between studies. Due to sparse data for each threshold reported, it was not possible to identify the best threshold for each test.Using data from 99 studies in an indirect test comparison, there was statistical evidence of a difference in diagnostic accuracy between urea breath test-13C, urea breath test-14C, serology and stool antigen test (P = 0.024). The diagnostic odds ratios for urea breath test-13C, urea breath test-14C, serology, and stool antigen test were 153 (95% confidence interval (CI) 73.7 to 316), 105 (95% CI 74.0 to 150), 47.4 (95% CI 25.5 to 88.1) and 45.1 (95% CI 24.2 to 84.1). The sensitivity (95% CI) estimated at a fixed specificity of 0.90 (median from studies across the four tests), was 0.94 (95% CI 0.89 to 0.97) for urea breath test-13C, 0.92 (95% CI 0.89 to 0.94) for urea breath test-14C, 0.84 (95% CI 0.74 to 0.91) for serology, and 0.83 (95% CI 0.73 to 0.90) for stool antigen test. This implies that on average, given a specificity of 0.90 and prevalence of 53.7% (median specificity and prevalence in the studies), out of 1000 people tested for H pylori infection, there will be 46 false positives (people without H pylori infection who will be diagnosed as having H pylori infection). In this hypothetical cohort, urea breath test-13C, urea breath test-14C, serology, and stool antigen test will give 30 (95% CI 15 to 58), 42 (95% CI 30 to 58), 86 (95% CI 50 to 140), and 89 (95% CI 52 to 146) false negatives respectively (people with H pylori infection for whom the diagnosis of H pylori will be missed).Direct comparisons were based on few head-to-head studies. The ratios of diagnostic odds ratios (DORs) were 0.68 (95% CI 0.12 to 3.70; P = 0.56) for urea breath test-13C versus serology (seven studies), and 0.88 (95% CI 0.14 to 5.56; P = 0.84) for urea breath test-13C versus stool antigen test (seven studies). The 95% CIs of these estimates overlap with those of the ratios of DORs from the indirect comparison. Data were limited or unavailable for meta-analysis of other direct comparisons. Authors' conclusions: In people without a history of gastrectomy and those who have not recently had antibiotics or proton ,pump inhibitors, urea breath tests had high diagnostic accuracy while serology and stool antigen tests were less accurate for diagnosis of Helicobacter pylori infection.This is based on an indirect test comparison (with potential for bias due to confounding), as evidence from direct comparisons was limited or unavailable. The thresholds used for these tests were highly variable and we were unable to identify specific thresholds that might be useful in clinical practice.We need further comparative studies of high methodological quality to obtain more reliable evidence of relative accuracy between the tests. Such studies should be conducted prospectively in a representative spectrum of participants and clearly reported to ensure low risk of bias. Most importantly, studies should prespecify and clearly report thresholds used, and should avoid inappropriate exclusions.
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The aim of our study is to asses the incidence of duodenal ulcer in the Digestive Endoscopy Laboratory of the County Hospital from Tg. Mures, Romania, and to make a complex study on this issue. Material and methods: 8589 patients were referred to our Laboratory in two years, from which 2258 were diagnosed with duodenal ulcer. In all these patients we performed tests for Helicobacter pylori, followed the main symptoms, the presence of other risk factors. 60 patients were randomized in three groups of 20, each group receiving a different therapy regimen. Group A was treated with Pantoprazole, Clarithromicine and Amoxicilline, Group B with Omeprazole, Metronidazole and Amoxicilline in standard doses for 7 days, Group C with Ranitidine, one month. After 6 and 12 month each patient was reevaluated for the relapse of the duodenal ulcer and the presence of Helicobacter pylori. Results: The prevalence of Helicobacter pylori was 92%.Mean age 46,57 years. The most common symptoms were epigastric pain and pirosis. As risk factors, smoking was the most frequent. Helicobacter pylori was eradicated in 95% in group A and 90% in group B. Relapses were very rare in these groups. Conclusion: There is a high prevalence of duodenal ulcer cases. The high rate of Helicobacter pylori and the good results of the eradication therapy regimens, conclude the importance of these treatments in order to prevent relapses.
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Background: Increasing resistance against Helicobacter pylori has resulted in reduced eradication rates. Objective: This study aims to determine whether eradication rates for H. pylori infection with sequential therapy is better than standard triple therapy. Patients: Patients with endoscopy documented peptic ulcer and H. pylori infection confirmed by histology and rapid urease test. Intervention: Patients were randomized into two groups; 134 received standard triple therapy (pantoprazole 40 mg, clarithromycin 500 mg and amoxicillin 1 g each administered twice daily) for 10 days and 138 received sequential regimen (pantoprazole 40 mg plus amoxicillin 1 g twice daily for 5 days followed by 40 mg pantoprazole, 500 mg clarithromycin, and 500 mg tinidazole each administered twice daily for 5 days). Eradication was confirmed by histology and rapid urease test. Compliance and adverse effects were determined by the recovery of empty medicine strips and questioning. Results: The eradication rates with sequential therapy were significantly greater than with standard therapy on both intention-to-treat analysis (76.0 % vs. 61.9 %, p = 0.005; difference, 14.1 % [95 % CI, 6.5-19 %] and per protocol analysis (84.6 % vs. 67.4 %, p = 0.002; difference, 17.2 % [95 % CI, 8.5-23.5 %]). The incidence of side effects did not differ between the two therapy groups. One patient in standard therapy discontinued treatment due to side effects. Limitation: Cultures were not performed. Loss to follow up was 5.2 % in standard therapy and 6.5 % in sequential therapy. Conclusion: Sequential therapy was significantly more effective than standard therapy for eradicating H. pylori infection in peptic ulcer disease in Asian patients. Side effects were similar.
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This past year the focus has remained on non-invasive tests, and more specifically the antigen stool test for which a number of studies have been published, validating its use for screening as well as for post-therapy follow-up. The possibilities offered by antibody testing have been further explored. A new antibody test in urine has emerged while use of the urea breath test, which is now standardized has been extended to children. Biopsy-based tests, especially culture, continue to be of great value for macrolide susceptibility testing, but new molecular methods such as a PCR hybridization assay have also been proposed.
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OBJECTIVE:The eradication of Helicobacter pylori (H. pylori) in patients with bleeding peptic ulcer disease (PUD) decreases the rate of ulcer rebleeding. Although all methods for H. pylori diagnosis have been extensively evaluated in uncomplicated PUD the efficacy of the commonly used rapid urease test (RUT) has not been established in patients with bleeding peptic ulcer disease. The aim of this study was to evaluate the efficacy of the RUT (CLOtest) in patients with bleeding duodenal ulcers (DUs).METHODS:Consecutive patients with symptoms of upper GI tract hemorrhage and a DU at the time of endoscopy were evaluated. The presence of H. pylori infection was determined by RUT, microbiology, and histology. Consecutive patients with uncomplicated DUs were similarly evaluated. The prevalence of H. pylori as determined by the RUT alone was compared to that determined by a combination of all tests in both patient groups.RESULTS:Fifty-five patients with bleeding DUs and 69 with nonbleeding DUs were evaluated. The prevalence of H. pylori in patients presenting with bleeding was 72.7% (95% confidence interval [CI] 61.0–84.5%) and lower than the prevalence rate of 92.8% (95% CI 86.6–98.8%) in patients with uncomplicated PUD (p < 0.05). The prevalence of H. pylori in the bleeding DU group as determined by RUT alone (54.5%) was less than that determined by a combination of all tests (73%) with a false-negative rate of 10 of 40 (25%; 95% CI 11.6–38.4%) (p < 0.05). This false-negative rate was significantly greater than that observed in the group presenting with dyspepsia (1 of 64 [1.6%; 95% CI 0–4.6%]) (p < 0.01).CONCLUSIONS:The prevalence of H. pylori is lower in patients with bleeding DUs when compared to patients with uncomplicated DUs. In addition, the sensitivity and negative predictive value of the RUT is lower in patients presenting with bleeding, and other methods of H. pylori diagnosis should be used in this patient group.
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The American Journal of Gastroenterology is published by Nature Publishing Group (NPG) on behalf of the American College of Gastroenterology (ACG). Ranked the #1 clinical journal covering gastroenterology and hepatology*, The American Journal of Gastroenterology (AJG) provides practical and professional support for clinicians dealing with the gastroenterological disorders seen most often in patients. Published with practicing clinicians in mind, the journal aims to be easily accessible, organizing its content by topic, both online and in print. www.amjgastro.com, *2007 Journal Citation Report (Thomson Reuters, 2008)
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The validity of the rapid urease (CLO) test to diagnose Helicobacter pylori infection in patients with bleeding ulcers has been questioned. The aim of this paper is to evaluate the validity of the CLO test in comparison with histology in diagnosing H. pylori infection in patients with acute upper gastrointestinal bleeding (UGB), irrespective of non-steroidal anti-inflammatory drug (NSAID) use. Upper gastrointestinal endoscopy was performed within 24 h of admission for all patients with UGB admitted to the Department of Pathophysiology, Medical School, Athens, for a period of 12 months. Patients with variceal bleeding, previous gastric operation, recent treatment with proton pump inhibitors (< 2 months) and those with a history of H. pylori eradication therapy were excluded from the study. At least four biopsies (two from the antrum and two from the body) were obtained for the CLO test and histology (modified Giemsa). Seventy-two consecutive patients (aged 18-90 years, 51 men, 21 women) were included. Forty-six patients (64%) used NSAID. Thirty-two patients (44%) were found to be positive for H. pylori infection by the CLO test, while 44 patients (61%) were found to be positive on histology (P<0.045, 95% CI, 0.004-0.331). The sensitivity and specificity of the CLO test were 68 and 93% respectively; positive and negative predictive values were 94 and 65%, respectively. The age of the patient and visible blood in the stomach did not influence results of either the CLO or histology. The CLO test, performed within 24 h of hospital admission in patients with UGB, irrespective of NSAID use, is unreliable for the detection of H. pylori infection. The age of the patient and the presence of blood in the stomach do not seem to influence these results.
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1, no fue hasta 1983 cuando Warren y Marshall relacionaron la presencia de estos microorganismos con la gastritis observada en los estomagos analizados 2 . Este hallazgo, que sin lugar a dudas ha revolucionado la gastroenterologia moderna, se realizo utilizando la tincion histologica de plata de Warthin-Starry. Desde esta primera identificacion de H. pylori se han desarrollado diversas y variadas tecnicas diagnosticas para investigar si una persona esta infectada por ese microorga
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Introduction Upper gastrointestinal bleeding continues to be a severe and frequent complication in ulcerative disease. Etiologic diagnosis in these patients is highly important in order to initiate appropriate treatment and prevent bleeding recurrence. Objective 1. To investigate the prevalence of Helicobacter pylori infection and use of NSAIDs in patients with upper gastrointestinal hemorrhage of peptic origin. 2. To analyze the strategy used for the diagnosis of H.pylori in our previous work. Patients and Methods Seventy-three patients with endoscopically- diagnosed upper gastrointestinal bleeding of peptic origin were included in the study. The use of NSAIDs was investigated. H.pylori infection was diagnosed if one of the following tests was positive: urease test, histology, breath test. Results H.pylori infection was found in 92% of duodenal ulcers and in 88% of gastric ulcers. Fifty-six percent of the patients had taken NSAIDs. Excluding these patients resulted in an H.pylori infection rate of 96.7%. The diagnosis was based on urease test in 46%. In the remaining patients, breath test and histology were required. Conclusions The main etiology in patients with upper gastrointestinal bleeding of peptic origin is H.pylori infection followed by the use of NSAIDs, and these two factors frequently coexist. The strategy of performing a urease test and, when this is negative, performing histological study and a breath test, is valid and allows a diagnosis of H.pylori infection to be made even if patients are receiving treatment that could make diagnosis difficult.
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Current tests used to detect Helicobacter pylori are either invasive (histological detection, culture, the polymerase chain reaction (PCR), smear examination) or non-invasive (serology, 13C-urea breath test). These tests vary in their sensitivity and specificity, and the choice of test will depend on the situation, for example, whether the test is to detect infection or the success of eradication treatment. The accuracy of histological tests depends, to a large degree, on the expertise of the pathologist, while the accuracy of culture can depend on the conditions in which the specimen is transported and processed. When performed under optimal conditions, both techniques give very good results. The PCR test has similar sensitivity and specificity to histological and culture tests but a strict protocol must be followed to avoid contamination with H. pylori DNA. The rapid urease test (with a reading taken 1 hour later) is suitable for diagnosis before treatment but its sensitivity decreases after treatment. Smear examination has limited sensitivity. The urea breath test and serology (specific IgG detected by enzyme-linked immunosorbent assay with purified antigens) have sensitivities close to those using the best of the biopsy methods. Other points to consider when selecting a test are its availability, the rapidity of the results (which can range from a few minutes to 2 weeks), possibilities for retrospective analysis, quantification and the detection of pathogenic properties, the globality of certain tests that present an overall picture of the stomach, thus avoiding errors in sampling, and the cost of the test. Important added value can be gained from certain tests: histology allows evaluation of the status of the mucosa, culture allows strain typing and tests for antibiotic susceptibility, and the breath test can confirm successful eradication without endoscopy. When the diagnostic tests are performed correctly, most of them are highly accurate.
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Our objective was to assess the effectiveness of therapy for Helicobacter pylori (HP) on the prevention of recurrent bleeding in patients with recent upper gastrointestinal hemorrhage from peptic ulcers. We performed a prospective follow-up study without randomization on 125 consecutive patients (83 males and 42 females) who had presented with their first major episode of upper gastrointestinal hemorrhage from peptic ulcer (22 gastric and 103 duodenal ulcers). All 125 patients were HP-positive. During the acute phase of bleeding, all patients were treated with standard supportive measures. After the acute bleeding phase, patients were allocated to two treatment groups: 1) antimicrobial therapy-84 patients received one of the following three regimens: 1) amoxicillin 500 mg t.i.d. for 10 days + omeprazole 20 mg b.i.d. for 30 days; 2) clarythromycin 500 mg t.i.d. for 12 days + omeprazole 20 mg b.i.d. for 30 days; or 3) amoxicillin 500 mg t.i.d. for 10 days + metronidazole 500 mg t.i.d. for 10 days + colloidal bismuth subcitrate 240 mg b.i.d. for 30 days. For long-term antisecretion maintenance treatment, 41 patients were allocated to either omeprazole 20 mg once a day or ranitidine 150 mg once a day, for 1 yr. During the follow-up period, peptic ulcers recurred in six patients in the antibiotic group (7.14%) and 13 patients in the maintenance group (31.7%) (p < 0.001). The fraction of patients without recurrent bleeding was greater in the antibiotic group than in the maintenance group. Two patients in the antibiotic group (2.3%) and five in the maintenance group (12.1%) had recurrent hemorrhages (p < 0.1). Cure of HP infection reduces the recurrence of peptic ulcer and of rebleeding from ulcer disease more effectively than does long-term maintenance therapy.
Article
Long-term prophylaxis with ranitidine reduces the risk of recurrent bleeding in patients with a history of bleeding peptic ulcers. To date, no randomized study has been performed to compare cure of Helicobacter pylori infection versus H2 blocker prophylaxis in patients with bleeding peptic ulcer. In a prospective randomized study, 95 consecutive patients with H. pylori-associated peptic ulcer bleeding were randomized to either ranitidine prophylaxis (150 mg at night) for 2 years or to H. pylori-eradication with omeprazole 60 mg twice daily plus amoxicillin 750 mg three times daily for 10 days. (Intention-to-treat analysis). Forty-eight patients were enrolled in the ranitidine group; 47 in the omeprazole-plus-amoxicillin group. Mean follow-up was 576 days (77 to 730). Ulcer recurrence rate was 31.3% in the ranitidine group (group 1) versus 6.37% in the eradication group (group 2; p = 0.0018). More patients had recurrent bleeding in group 1 (8.3%) than in group 2 (4.2%) but we were not able to show a statistically significant difference with respect to recurrent bleeding between groups (p = 0.29). Definite cure of H. pylori infection was achieved in 89.3%. Cure of H. pylori infection reduces recurrence of peptic ulcer and therefore rebleeding more effectively than does long-term maintenance therapy with an H2 blocker.