Otero R, Gutiérrez J M, Rojas G, Núñez V, Díaz A, Miranda E, Uribe A F, Silva J F, Ospina J G, Medina Y, Toro M F, García M E, León G, García M, Lizano S, De La Torre J, Márquez J, Mena Y, González N, Arenas L C, Puzón A, Blanco N, Sierra A, Espinal M E, Lozano R
Centro de Investigaciones Médicas, Departamento de Pediatría, Facultad de Medicina, Universidad de Antioquia, Medellín, Colombia.
Toxicon. 1999 Jun;37(6):895-908. doi: 10.1016/s0041-0101(98)00220-7.
A randomized blinded clinical trial was performed in 53 patients bitten by Bothrops sp. and Porthidium sp. in Antioquia and Chocó, Colombia, in order to compare the efficacy and safety of two antivenoms made of whole IgG obtained by either ammonium sulphate (monovalent anti-B. atrox) or caprylic acid (polyvalent) fractionation. Additionally, antivenoms were compared by electrophoretic and chromatographic analyses and anticomplementary activity in vitro. With a protocol of 2, 4 and 6 antivenom vials for the treatment of mild, moderate and severe envenomings, respectively, both antivenoms were equally efficient to neutralize the most relevant signs of envenoming and to clear serum venom levels in patients from the first hour and later on. Three patients with severe envenoming and initially treated with less than six vials on admission had persistent or recurrent venom antigenemia within 12-48 h. Monovalent antivenom fractionated by ammonium sulphate precipitation had higher amounts of protein aggregates and nonimmunoglobulin proteins than polyvalent antivenom fractionated by caprylic acid precipitation. Both antivenoms presented anticomplementary activity in vitro, being higher in the monovalent product. In agreement, monovalent antivenom induced a significantly higher incidence of early antivenom reactions (52%) than polyvalent antivenom (25%).
在哥伦比亚安蒂奥基亚和乔科省，对53例被矛头蝮属和猪鼻蝰属咬伤的患者进行了一项随机双盲临床试验，以比较通过硫酸铵（单价抗矛头蝮）或辛酸（多价）分级分离获得的两种全IgG抗蛇毒血清的疗效和安全性。此外，还通过电泳和色谱分析以及体外抗补体活性对两种抗蛇毒血清进行了比较。按照分别用2、4和6瓶抗蛇毒血清治疗轻度、中度和重度蛇伤的方案，两种抗蛇毒血清在中和蛇伤最相关体征以及从第一小时起及之后清除患者血清毒液水平方面同样有效。3例重度蛇伤患者入院时最初接受的抗蛇毒血清少于6瓶，在12至48小时内出现了持续或复发性毒液抗原血症。通过硫酸铵沉淀分级分离的单价抗蛇毒血清比通过辛酸沉淀分级分离的多价抗蛇毒血清含有更多的蛋白质聚集体和非免疫球蛋白蛋白质。两种抗蛇毒血清在体外均表现出抗补体活性，单价产品的活性更高。与此一致的是，单价抗蛇毒血清引起的早期抗蛇毒血清反应发生率（52%）明显高于多价抗蛇毒血清（25%）。
