Facultad de Medicina, Universidad de Antioquia, A.A. 1226, Medellín, Colombia.
Toxicon. 2012 Feb;59(2):344-55. doi: 10.1016/j.toxicon.2011.11.017. Epub 2011 Nov 29.
The efficacy and safety of two polyvalent horse-derived antivenoms in Bothrops asper envenomings were tested in a randomized, double-blind, clinical trial performed in Colombia. Both antivenoms were manufactured from the same pool of hyperimmune plasma. Antivenom A was made of F(ab')2 fragments, generated by pepsin digestion and caprylic acid precipitation, whereas antivenom B consisted of whole IgG molecules produced by caprylic acid precipitation followed by ion-exchange chromatography. Besides the different nature of the active substance, antivenom B had higher protein concentration, slightly higher turbidity and aggregate content. No significant differences were observed in the efficacy of antivenoms. Both halted local and systemic bleeding (P = 0.40) within 6-12 h of treatment in 100% of the cases, and restored blood coagulation (P = 0.87) within 6-24 h in 84.7% of patients, and within 48 h in all of them, in agreement with restoration of plasma fibrinogen concentration. Venom concentrations in serum dropped significantly (P < 0.001), to very low levels, 1 h after antivenom infusion. Nevertheless, eight patients (11.1%), four for each antivenom, presented recurrence of venom antigenaemia at different times, from 6 to 96 h, with clinical significance (recurrent coagulopathy) only in one group B patient (2.9%). Serum creatine kinase (CK) activity was increased, as a consequence of local myonecrosis. There was no significant difference (P = 0.51) in the incidence of early adverse reactions to antivenom administration (28.9% for patients of group A and 20.6% for patients of group B), most of the reactions being mild, mainly cutaneous. The most frequent complications were cellulitis (16.7%), abscess formation (5.6%), acute renal failure (8.3%), and compartmental syndrome (5.6%). In conclusion, IgG and F(ab')2 antivenoms, prepared by caprylic acid fractionation, presented similar efficacy and safety profiles for the treatment of B. asper envenomings in Colombia.
在哥伦比亚进行的一项随机、双盲、临床试验中，测试了两种源自马的多价抗蛇毒血清在处理矛头蝮属蛇咬伤中的疗效和安全性。两种抗蛇毒血清均由同一池免疫血浆制成。抗蛇毒血清 A 由胃蛋白酶消化和辛酸沉淀产生的 F(ab')2 片段组成，而抗蛇毒血清 B 由辛酸沉淀产生的完整 IgG 分子组成，随后进行离子交换层析。除了活性物质的性质不同外，抗蛇毒血清 B 的蛋白浓度较高，浊度和聚集物含量略高。两种抗蛇毒血清的疗效没有显著差异。在治疗后 6-12 小时内，100%的病例均停止了局部和全身出血（P = 0.40），84.7%的患者在 6-24 小时内恢复了凝血（P = 0.87），所有患者在 48 小时内恢复了凝血，这与血浆纤维蛋白原浓度的恢复一致。血清中毒素浓度显著下降（P < 0.001），在抗蛇毒血清输注后 1 小时降至非常低的水平。然而，有 8 名患者（11.1%），每一种抗蛇毒血清各有 4 名，在不同时间出现了毒液抗原血症的复发，时间从 6 小时到 96 小时，只有一组 B 患者（2.9%）出现了临床意义上的复发性凝血功能障碍。血清肌酸激酶（CK）活性因局部肌坏死而升高。抗蛇毒血清给药后早期不良反应的发生率无显著差异（A 组患者为 28.9%，B 组患者为 20.6%）（P = 0.51），大多数反应为轻度，主要为皮肤反应。最常见的并发症是蜂窝织炎（16.7%）、脓肿形成（5.6%）、急性肾衰竭（8.3%）和间隔综合征（5.6%）。总之，用辛酸分馏法制备的 IgG 和 F(ab')2 抗蛇毒血清在治疗哥伦比亚的矛头蝮属蛇咬伤方面具有相似的疗效和安全性。
