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The case of a 72-year-old woman with probable severe acute respiratory syndrome is reported. While on treatment with ribavirin and antibiotics (for community-acquired pneumonia), the patient continued to have progressive clinical deterioration and chest radiographic evidence of respiratory deterioration. Pulse dose intravenous corticosteroids were...
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Intravenous (IV) ribavirin does not have US Food and Drug Administration (FDA) approval, although oral and aerosol formulations have been approved. Intravenous ribavirin can, however, be authorized for use as a result of an Emergency Investigational New Drug (EIND) application as investigational treatment for patients with serious viral infections, including emerging or rare infections for which no alternative treatment is available. This retrospective study evaluated clinical experience with IV ribavirin based on a review of the FDA's EIND database and a literature review. The main outcome measures were disease condition, clinical outcomes, and adverse events (AEs). First, the FDA's EIND database was evaluated for these variables among patients authorized to receive investigational IV ribavirin. Second, published literature on IV ribavirin was reviewed for diseases treated, reported clinical outcomes, and AEs. Adverse events reported in the literature were compared with AEs listed in approved product labeling (aerosol and oral formulations). From February 1997 to December 2008, 608 IV ribavirin EIND requests were made for 19 disease conditions. Adenovirus, respiratory syncytial virus, and parainfluenza infections comprised 84.7% of IV ribavirin EINDs. Inadequate reporting of clinical outcomes and AEs in the EIND database prevented analysis of either outcome. Data interpretation in the literature was limited by multiple factors, including retrospective design, small sample sizes, differences in reporting outcomes and AEs, lack of generalizability, and potential confounders such as concomitant medications, selection bias, and reporting bias. Reported AEs were consistent with labels of approved aerosol and oral formulations, except for lip and gingival swelling. However, estimates of frequency, severity, and causality of AEs associated with IV ribavirin could not be determined because of study limitations. Our study findings suggest that the literature is inconclusive on the potential benefit for continued use of IV ribavirin. A review of the literature and the FDA's EIND database suggests that prospective, controlled trials of IV ribavirin in patients with adenovirus, parainfluenza, or serious respiratory syncytial virus infections could be feasible.
To investigate the efficacy and safety profiles of corticosteroid therapy in severe acute respiratory syndrome (SARS) patients.
Four hundred one of 1,278 SARS cases treated in Guangzhou China between December 2002 and June 2003 fulfilled the diagnostic criteria issued by the World Health Organization for confirmed identification of SARS. Among them, the diagnosis of critical SARS was defined by criteria of SARS guidelines incorporated with a low oxygenation index (OI) [< 300 mm Hg]. Data of these patients retrieved from a database were retrospectively analyzed by logistic regression and Cox regression for the effect of corticosteroid therapy on death, hospitalization days, and complication presentation.
Among the 401 SARS patients studied, 147 of 249 noncritical patients (59.0%) received corticosteroids (mean daily dose, 105.3 +/- 86.1 mg) [+/- SD], and all survived the disease; 121 of 152 critical patients (79.6%) received corticosteroids at a mean daily dose of 133.5 +/- 102.3 mg, and 25 died. Analysis of these 401 confirmed cases did not show any benefits of corticosteroid on the death rate and hospitalization days. However, when focused on 152 critical SARS cases, factors correlated with these end points indicated by univariate analysis included use of corticosteroid, age, rigor at onset, secondary respiratory infections, pulmonary rales, grading of OI, and use of invasive ventilation. After adjustment for possible confounders, treatment with corticosteroid was shown contributing to lower overall mortality, instant mortality, and shorter hospitalization stay (p < 0.05). Incidence of complications was significantly associated with the need for invasive ventilation but not with use of corticosteroids.
This Guangzhou retrospective study revealed that proper use of corticosteroid in confirmed critical SARS resulted in lowered mortality and shorter hospitalization stay, and was not associated with significant secondary lower respiratory infection and other complications.
