Department of Critical Care Medicine, Toxicology and Emergency, CHU Martinique (University Hospital of Martinique), 97200 Fort-de-France, France.
Cardiovascular Research Team UR5_3 PC2E Pathologie Cardiaque, Toxicité Environnementale et Envenimations, Université des Antilles, 97233 Fort-de-France, France.
Toxins (Basel). 2024 Mar 13;16(3):146. doi: 10.3390/toxins16030146.
Bothrofav, a monospecific antivenom, was introduced in June 1991 and has shown excellent effectiveness against life-threatening and thrombotic complications of envenoming. Because of the reoccurrence of cerebral stroke events despite the timely administration of antivenom, new batches of Bothrofav were produced and introduced into clinical use in January 2011. This study's aim was to evaluate the effectiveness of Bothrofav generations at treating envenoming. During the first period of the study (2000-2010), 107 patients were treated with vials of antivenom produced in June 1991, while 282 envenomed patients were treated with vials of antivenom produced in January 2011 in the second study period (2011-2023). Despite timely antivenom administration, thrombotic complications reoccurred after an interval free of thrombotic events, and a timeframe analysis suggested that the clinical efficacy of Bothrofav declined after it reached its 10-year shelf-life. In of the case of an antivenom shortage due to the absence of regular batch production, no adverse effects were identified before the antivenom reached its 10-year shelf-life, which is beyond the accepted shelf-life for a liquid-formulation antivenom. While our study does not support the use of expired antivenom for potent, life-threatening envenoming, it can be a scientific message to public entities proving the necessity of new antivenom production for envenoming.
Bothrofav 是一种单特异性抗蛇毒血清,于 1991 年 6 月推出,已被证明对危及生命和血栓形成并发症的蛇咬伤具有极好的疗效。由于尽管及时使用了抗蛇毒血清,但仍反复发生中风事件,因此于 2011 年 1 月生产并引入了新批次的 Bothrofav 进行临床使用。本研究旨在评估不同批次 Bothrofav 在治疗蛇咬伤方面的效果。在研究的第一阶段(2000-2010 年),107 名患者接受了 1991 年 6 月生产的抗蛇毒血清治疗,而在第二阶段(2011-2023 年),282 名蛇咬伤患者接受了 2011 年 1 月生产的抗蛇毒血清治疗。尽管及时使用了抗蛇毒血清,但在无血栓事件发生的间隔后仍出现血栓形成并发症,且时间框架分析表明,Bothrofav 在达到 10 年保质期后其临床疗效下降。在由于没有定期批量生产而导致抗蛇毒血清短缺的情况下,在抗蛇毒血清达到 10 年保质期之前,没有发现任何不良反应,这超出了液体配方抗蛇毒血清的可接受保质期。虽然我们的研究不支持在出现严重致命蛇咬伤时使用过期抗蛇毒血清,但它可以为公共实体提供一个科学信息,证明生产新的抗蛇毒血清以应对蛇咬伤的必要性。