蝎毒注射液镇痛效果及安全性临床评价

Clinical evaluation of analgesic effect and safety of scorpion venom injection

目的 评价蝎毒注射液的镇痛效果和不良反应。方法 多中心随机双盲平行对照试验和开放试验 ,对照药丁丙诺啡、曲马多和安慰剂 ,用于手术后疼痛、神经疼痛和癌症疼痛等中度疼痛患者。全部试验完成 46 6例 ,其中试验药 315例 ,对照药15 1例。试验分组为单次给药、3d给药和 1～ 2周给药 ,每次剂量为 10～ 2 0 μg。 结果 蝎毒具有确切的镇痛效果 ,镇痛强度中等偏下。注射后 15～ 30min起效 ,达峰时间 2h左右 ,持续时间 4～ 6h。不良反应有头晕、胃不适、恶心、便秘和皮肤搔痒等 ,发生率很低 ;对呼吸、血压、心率无影响 ,对肝肾功能无影响。

OBJECTIVE To evaluate the clinical analgesic effect and adverse drug reactions of scorpion venom injection(the test drug).METHOD A multi center,randomized,double blind, parallel controlled clinical trial and an open trial were conducted to investigate the effect of the test drug for relieving moderate postoperative pain, neuropathic pain,and cancer pain respectively.Buprenorphine, tramadol, and placebo were used as the control drugs. The number of final clinical evaluated subjects was 466 including 315 subjects for the test drug and 151 subjects for the control drugs (buprenorphine 60 subjects,tramadol 30 subjects,placebo 61 subjects).The duration of treatment was divided into a single dose, 3 days and 1～2 weeks at dosages of 10～20 μg respectively.RESULTS Scorpion venom injection showed analgesic effects with infra moderate intensity.The effect occurred within 30 min after administration,then, it reached peak about 2 h,and persisted 4～6 h.The incidences of adverse drug reactions, including dizziness, stomach upset, nausea, constipation and itching etc, were lower.There was no evident influence on respiration, blood pressure, heart rate, hepatic and renal functions by the test drug.CONCLUSION Scorpion venom injection was effective and safe in the control of moderate pain.