Cardoso J L, Fan H W, França F O, Jorge M T, Leite R P, Nishioka S A, Avila A, Sano-Martins I S, Tomy S C, Santoro M L
Instituto Butantan, São Paulo, Brasil.
Q J Med. 1993 May;86(5):315-25.
In São Paulo City, Brazil, 121 patients with moderately severe envenoming by Bothrops snakes (principally B. jararaca) were randomized for treatment with Brazilian polyspecific Bothrops antivenoms: Instituto Butantan (39 patients), Instituto Vital Brazil (41), Fundação Ezequiel Dias (FUNED) (41). The initial dose was four ampoules (40 ml) in 89 patients with less severe envenoming and eight ampoules (80 ml) in 32 patients with more severe envenoming. A second dose of four ampoules was required in 20 patients. Patients receiving the three antivenoms were comparable in all respects before treatment. There were no deaths. The majority showed rapid clinical improvement, resolution of local envenoming, cessation of bleeding and restoration of blood coagulability. No differences in the efficacy of the three antivenoms were revealed by clinical or laboratory observations, including measures of haematological, haemostatic and biochemical abnormalities. Twelve patients developed abscesses (Butantan 1, Vital Brazil 6, FUNED 5) and seven developed local necrosis (3,1,3). Of 88 patients followed up 20-30 days after the bite 33 (37.5%) still had symptoms or signs of local envenoming, especially swelling. Early (anaphylactic) reactions were unexpectedly frequent after all three antivenoms but were significantly more frequent with Butantan (87%) than with Vital Brazil (37%) or FUNED (56%) antivenoms (p < 0.001). A possible explanation was the higher total protein content and percentage immunoglobulin of Butantan antivenom. The doses of antivenom recommended in Brazil and used in this study may be unnecessarily high, resulting in an unacceptably high incidence of reactions. Results of the study should prompt a critical re-evaluation of antivenom production techniques and dosage recommendations in Brazil.
在巴西圣保罗市，121名被矛头蝮蛇（主要是巴西矛头蝮）中度严重咬伤的患者被随机分配接受巴西多价矛头蝮抗蛇毒血清治疗：布坦坦研究所（39名患者）、巴西维塔尔研究所（41名）、埃泽奎埃尔·迪亚斯基金会（FUNED）（41名）。89名中毒较轻的患者初始剂量为四支安瓿（40毫升），32名中毒较重的患者初始剂量为八支安瓿（80毫升）。20名患者需要注射第二剂四支安瓿。接受三种抗蛇毒血清治疗的患者在治疗前各方面情况相当。无一例死亡。大多数患者临床症状迅速改善，局部中毒症状消退，出血停止，血液凝固性恢复。临床或实验室观察，包括血液学、止血和生化异常指标，均未显示三种抗蛇毒血清在疗效上有差异。12名患者出现脓肿（布坦坦研究所1例、巴西维塔尔研究所6例、FUNED 5例），7名患者出现局部坏死（分别为3例、1例、3例）。在咬伤后20 - 30天接受随访的88名患者中，33名（37.5%）仍有局部中毒的症状或体征，尤其是肿胀。三种抗蛇毒血清注射后早期（过敏）反应均出人意料地频繁，但布坦坦抗蛇毒血清引发的反应明显比巴西维塔尔抗蛇毒血清（37%）或FUNED抗蛇毒血清（56%）更频繁（p < 0.001）。一个可能的解释是布坦坦抗蛇毒血清的总蛋白含量和免疫球蛋白百分比更高。巴西推荐并在本研究中使用的抗蛇毒血清剂量可能过高，导致反应发生率高得令人无法接受。该研究结果应促使对巴西抗蛇毒血清生产技术和剂量建议进行批判性重新评估。
