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From the top, LaryngoFlex w with a flange derived from a reinforced tracheostomy tube ULTRA TracheoFlex w , ULTRA TracheoFlex w , and a standard tracheostomy tube (Portex w ).
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Objective:
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Citations
... VGSCs are crucial in pain, and research has shown that some types of TTX-sensitive VGSCs are directly related to chronic pain, especially neuropathic pain [27,28]. Preclinical evidence has shown that the systemic administration of TTX has efficacy in classical models of pain [29], in a model of carrageenaninduced inflammatory mechanical hyperalgesia [30], and in different models of visceral pain [31]. In addition, TTX reduced pain behaviors in different models of neuropathic pain, including neuropathic pain induced by nerve injury [29,32], postherpetic neuralgia [33], and chemotherapy-induced neuropathic pain [34,35], as well as in a model of bone cancer pain [36]. ...
... The studies were published from 2007 to 2021 in four countries: Canada, Australia, New Zealand, and the United States of America. Three of them were randomized clinical trials (RCTs) (Hagen et al. [31], Hagen et al. [33] (phase III; NCT00725114), and Goldlust et al. [34] (phase II; NCT01655823)), and the other two were non-controlled clinical trials (Hagen et al. [30] (phase IIa) and Hagen et al. [32], which was an open-label study conducted in patients who had previously participated in the RCT described in [31]). There was another clinical trial (NCT00726011), the results of which have not been published, that provided the option for all patients who participated in the TEC-006 study (NCT00725114) [41], both TTX-and placebo-treated, to receive or continue to receive TTX treatment. ...
... The studies were published from 2007 to 2021 in four countries: Canada, Australia, New Zealand, and the United States of America. Three of them were randomized clinical trials (RCTs) (Hagen et al. [31], Hagen et al. [33] (phase III; NCT00725114), and Goldlust et al. [34] (phase II; NCT01655823)), and the other two were non-controlled clinical trials (Hagen et al. [30] (phase IIa) and Hagen et al. [32], which was an openlabel study conducted in patients who had previously participated in the RCT described in [31]). There was another clinical trial (NCT00726011), the results of which have not been published, that provided the option for all patients who participated in the TEC-006 study (NCT00725114) [41], both TTX-and placebo-treated, to receive or continue to receive TTX treatment. ...
The pharmacological treatment of cancer-related pain is unsatisfactory. Tetrodotoxin (TTX) has shown analgesia in preclinical models and clinical trials, but its clinical efficacy and safety have not been quantified. For this reason, our aim was to perform a systematic review and meta-analysis of the clinical evidence that was available. A systematic literature search was conducted in four electronic databases (Medline, Web of Science, Scopus, and ClinicalTrials.gov) up to 1 March 2023 in order to identify published clinical studies evaluating the efficacy and security of TTX in patients with cancer-related pain, including chemotherapy-induced neuropathic pain. Five articles were selected, three of which were randomized controlled trials (RCTs). The number of responders to the primary outcome (≥30% improvement in the mean pain intensity) and those suffering adverse events in the intervention and placebo groups were used to calculate effect sizes using the log odds ratio. The meta-analysis showed that TTX significantly increased the number of responders (mean = 0.68; 95% CI: 0.19–1.16, p = 0.0065) and the number of patients suffering non-severe adverse events (mean = 1.13; 95% CI: 0.31–1.95, p = 0.0068). However, TTX did not increase the risk of suffering serious adverse events (mean = 0.75; 95% CI: −0.43–1.93, p = 0.2154). In conclusion, TTX showed robust analgesic efficacy but also increased the risk of suffering non-severe adverse events. These results should be confirmed in further clinical trials with higher numbers of patients.
... Inflammatory pain and acute pain have also been evaluated in preclinical studies. Although the data obtained are still unclear, they suggest that the administration of TTX might have little impact on these types of pain [282,284,285]. More studies are needed to evaluate the benefit of the administration of this toxin to control different types of pain. ...
Marine phycotoxins are a multiplicity of bioactive compounds which are produced by microalgae and bioaccumulate in the marine food web. Phycotoxins affect the ecosystem, pose a threat to human health, and have important economic effects on aquaculture and tourism worldwide. However, human health and food safety have been the primary concerns when considering the impacts of phycotoxins. Phycotoxins toxicity information, often used to set regulatory limits for these toxins in shellfish, lacks traceability of toxicity values highlighting the need for predefined toxicological criteria. Toxicity data together with adequate detection methods for monitoring procedures are crucial to protect human health. However, despite technological advances, there are still methodological uncertainties and high demand for universal phycotoxin detectors. This review focuses on these topics, including uncertainties of climate change, providing an overview of the current information as well as future perspectives.
... Indeed, Alguacil et al. [99] observed the antinociceptive effect of subcutaneous TTX injection in a rat carrageenan model. Rats were pre-treated with TTX (2.5 µg/kg) an hour before injection of carrageenan in the right paw. ...
... While the effects of TTX were slight, the toxin significantly reduced hyperalgesia in the affected paw. The observed minimal decrease in pain in this study as a result of a single subcutaneous injection of TTX suggests that TTX may be an ineffective treatment for severe inflammatory pain, and may be more helpful in mild, chronic inflammatory pain conditions [99]. ...
Tetrodotoxin (TTX) is a potent neurotoxin that was first identified in pufferfish but has since been isolated from an array of taxa that host TTX-producing bacteria. However, determining its origin, ecosystem roles, and biomedical applications has challenged researchers for decades. Recognized as a poison and for its lethal effects on humans when ingested, TTX is primarily a powerful sodium channel inhibitor that targets voltage-gated sodium channels, including six of the nine mammalian isoforms. Although lethal doses for humans range from 1.5–2.0 mg TTX (blood level 9 ng/mL), when it is administered at levels far below LD50, TTX exhibits therapeutic properties, especially to treat cancer-related pain, neuropathic pain, and visceral pain. Furthermore, TTX can potentially treat a variety of medical ailments, including heroin and cocaine withdrawal symptoms, spinal cord injuries, brain trauma, and some kinds of tumors. Here, we (i) describe the perplexing evolution and ecology of tetrodotoxin, (ii) review its mechanisms and modes of action, and (iii) offer an overview of the numerous ways it may be applied as a therapeutic. There is much to be explored in these three areas, and we offer ideas for future research that combine evolutionary biology with therapeutics. The TTX system holds great promise as a therapeutic and understanding the origin and chemical ecology of TTX as a poison will only improve its general benefit to humanity.
... Thus, the systemic administration of TTX has shown analgesic effect in classical pain models such as in the writhing test in mice [57] and rats [58], and in the formalin test in rats [57]. In another study, systemic TTX showed a significant reduction of mechanical hyperalgesia in a rat model of inflammatory pain induced by intraplantar carrageenan [59]. Our group demonstrated that the systemic administration of TTX reduced pain behaviors in different models of visceral pain in mice [60]. ...
Tetrodotoxin (TTX) is a potent neurotoxin found mainly in puffer fish and other marine and terrestrial animals. TTX blocks voltage-gated sodium channels (VGSCs) which are typically classified as TTX-sensitive or TTX-resistant channels. VGSCs play a key role in pain signaling and some TTX-sensitive VGSCs are highly expressed by adult primary sensory neurons. During pathological pain conditions, such as neuropathic pain, upregulation of some TTX-sensitive VGSCs, including the massive re-expression of the embryonic VGSC subtype NaV1.3 in adult primary sensory neurons, contribute to painful hypersensitization. In addition, people with loss-of-function mutations in the VGSC subtype NaV1.7 present congenital insensitive to pain. TTX displays a prominent analgesic effect in several models of neuropathic pain in rodents. According to this promising preclinical evidence, TTX is currently under clinical development for chemo-therapy-induced neuropathic pain and cancer-related pain. This review focuses primarily on the preclinical and clinical evidence that support a potential analgesic role for TTX in these pain states. In addition, we also analyze the main toxic effects that this neurotoxin produces when it is administered at therapeutic doses, and the therapeutic potential to alleviate neuropathic pain of other natural toxins that selectively block TTX-sensitive VGSCs.
... Despite the key role of TTX-sensitive Na v 1.7 channels in pain perception, a limited number of preclinical studies have been conducted to date on the ability of the toxin to relieve acute pain, and available data suggest that TTX has little impact in acute pain responses [71]. More promising results were obtained regarding the efficacy of TTX in the treatment of neurogenic chronic pain induced by experimental inflammation and, most of all, of neuropathic pain, where TTX has been demonstrated to significantly reduce hyperalgesia, mechanical allodynia, and spontaneous development of afferent activity caused by peripheral nerve injury [99][100][101][102][103]. Significant data on the analgesic efficacy of TTX have also been obtained in animal models of chemotherapy-induced peripheral neuropathy, which represents the major dose-limiting side effect of many chemotherapeutic drugs. ...
Visceral pain, of which the pathogenic basis is currently largely unknown, is a hallmark symptom of both functional disorders, such as irritable bowel syndrome, and inflammatory bowel disease. Intrinsic sensory neurons in the enteric nervous system and afferent sensory neurons of the dorsal root ganglia, connecting with the central nervous system, represent the primary neuronal pathways transducing gut visceral pain. Current pharmacological therapies have several limitations, owing to their partial efficacy and the generation of severe adverse effects. Numerous cellular targets of visceral nociception have been recognized, including, among others, channels (i.e., voltage-gated sodium channels, VGSCs, voltage-gated calcium channels, VGCCs, Transient Receptor Potential, TRP, and Acid-sensing ion channels, ASICs) and neurotransmitter pathways (i.e., GABAergic pathways), which represent attractive targets for the discovery of novel drugs. Natural biologically active compounds, such as marine toxins, able to bind with high affinity and selectivity to different visceral pain molecular mediators, may represent a useful tool (1) to improve our knowledge of the physiological and pathological relevance of each nociceptive target, and (2) to discover therapeutically valuable molecules. In this review we report the most recent literature describing the effects of marine toxin on gastrointestinal visceral pain pathways and the possible clinical implications in the treatment of chronic pain associated with gut diseases.
... In consequence, the mechanisms underlying visceral pain Mar. Drugs 2017, 15, 188 2 of 13 are still poorly understood; however, the development of animal models of visceral pain is allowing for the specific peripheral and central mechanisms involved to be investigated [8]. ...
... It has been reported that TTX has analgesic and antihyperalgesic effects in several somatic pain conditions, including nociceptive [13], inflammatory [13][14][15], muscle [16], and neuropathic [13,[17][18][19] pain models. In addition, TTX has been tested in humans in several clinical trials for counteracting cancer-related pain [20,21] and pain resulting from chemotherapy (clinical trial NCT01655823) [22]. ...
... In our study, the intracolonic capsaicin-and mustard oil-induced responses were evaluated for a time period much longer (20 min) than that of acute pain induced by intraplantar formalin (5 min) and, therefore, TTX might be acting in an inflammatory or sensitized pain state. In fact, TTX has previously been shown to reduce the pain behaviors in the second phase of the formalin test and the mechanical hyperalgesia induced by carrageenan in rats [13,15]. In any case, there are no reported results of TTX in spontaneous/acute pain models using chemical stimulus in mice to compare with our results, and further studies in somatic pain could help to clarify this issue. ...
Visceral pain is very common and represents a major unmet clinical need for which current pharmacological treatments are often insufficient. Tetrodotoxin (TTX) is a potent neurotoxin that exerts analgesic actions in both humans and rodents under different somatic pain conditions, but its effect has been unexplored in visceral pain. Therefore, we tested the effects of systemic TTX in viscero-specific mouse models of chemical stimulation of the colon (intracolonic instillation of capsaicin and mustard oil) and intraperitoneal cyclophosphamide-induced cystitis. The subcutaneous administration of TTX dose-dependently inhibited the number of pain-related behaviors in all evaluated pain models and reversed the referred mechanical hyperalgesia (examined by stimulation of the abdomen with von Frey filaments) induced by capsaicin and cyclophosphamide, but not that induced by mustard oil. Morphine inhibited both pain responses and the referred mechanical hyperalgesia in all tests. Conditional nociceptor‑specific Nav1.7 knockout mice treated with TTX showed the same responses as littermate controls after the administration of the algogens. No motor incoordination after the administration of TTX was observed. These results suggest that blockade of TTX-sensitive sodium channels, but not Nav1.7 subtype alone, by systemic administration of TTX might be a potential therapeutic strategy for the treatment of visceral pain.
... Systemic administration of either compound at the same dose as used in local administration (nanomolar concentration) was ineffective to prevent hyperalgesia [113]. However, a later study found that the preventive administration of systemic TTX (at micromolar concentration) slightly but significantly reduced carrageenan-induced mechanical hyperalgesia in rats [114]. Intrathecal TTX inhibited thermal hypersensitivity in a model of chronic inflammatory pain induced by complete Freund's adjuvant (CFA). ...
Tetrodotoxin (TTX) is a potent neurotoxin that blocks voltage-gated sodium channels (VGSCs). VGSCs play a critical role in neuronal function under both physiological and pathological conditions. TTX has been extensively used to functionally characterize VGSCs, which can be classified as TTX-sensitive or TTX-resistant channels according to their sensitivity to this toxin. Alterations in the expression and/or function of some specific TTX-sensitive VGSCs have been implicated in a number of chronic pain conditions. The administration of TTX at doses below those that interfere with the generation and conduction of action potentials in normal (non-injured) nerves has been used in humans and experimental animals under different pain conditions. These data indicate a role for TTX as a potential therapeutic agent for pain. This review focuses on the preclinical and clinical evidence supporting a potential analgesic role for TTX. In addition, the contribution of specific TTX-sensitive VGSCs to pain is reviewed.
