Instituto Clodomiro Picado, Facultad de Microbiología, Universidad de Costa Rica, San José, Costa Rica.
Toxicon. 2013 Jul;69:168-79. doi: 10.1016/j.toxicon.2012.11.016. Epub 2012 Nov 29.
The assessment of the capacity of antivenoms to neutralize the lethal activity of snake venoms is the gold standard in the preclinical analysis of antivenom efficacy, and is routinely performed by manufacturers and quality control laboratories. However, the complexity of snake venom composition and toxicological profile demands that, for many venoms, such as those of viperid snakes and some elapids, the neutralization of lethality be complemented with the analysis of the neutralization of other relevant toxic activities, such as hemorrhagic, myotoxic, necrotizing, procoagulant and defibrinogenating effects. This expanded protocol for preclinical testing of antivenoms should be used when a new antivenom is developed or when an existing antivenom is introduced in a new geographical setting for the neutralization of either homologous or heterologous venoms. In recent years, the assessment of the immunological reactivity of antivenoms has been enriched by the use of proteomic tools, with a methodology named 'antivenomics'. This allows the identification of venom components to which antivenoms have, or lack, antibodies, and thus complements the data gathered in neutralization tests, paving the way for a knowledge-based improvement of antivenom design and efficacy. International projects involving participants of manufacturing, quality control and academic research groups should be promoted in order to gain a deeper understanding on the preclinical neutralizing spectrum of antivenoms.
抗蛇毒血清中和蛇毒致死活性的能力评估是抗蛇毒血清疗效临床前分析的金标准，制造商和质量控制实验室通常都会进行这种评估。然而，蛇毒成分和毒理学特征的复杂性要求，对于许多毒液，如蝰蛇和某些眼镜蛇的毒液，在中和致死性的同时，还需要分析其他相关的毒性活性的中和作用，如出血、肌毒性、坏死、促凝和纤维蛋白溶解作用。当开发新的抗蛇毒血清或在新的地理环境中引入现有的抗蛇毒血清来中和同源或异源毒液时，应该使用这种扩展的抗蛇毒血清临床前测试方案。近年来，通过使用蛋白质组学工具，对抗蛇毒血清的免疫反应性进行了评估，这一方法被称为“抗蛇毒血清组学”。这可以鉴定抗蛇毒血清具有或缺乏抗体的毒液成分，从而补充中和试验中收集的数据，为基于知识的抗蛇毒血清设计和疗效的改进铺平道路。应该促进涉及制造商、质量控制和学术研究小组参与者的国际项目，以更深入地了解抗蛇毒血清的临床前中和谱。
