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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。结论 蝎毒注射液是控制中度疼痛的安全有效的药物
Objective To evaluate the analgesic effect and adverse reactions of Hudu injection. METHODS: A multicenter, randomized, double-blind parallel controlled trial and open-label trial with buprenorphine, tramadol, and placebo for moderate pain patients with postoperative pain, neuropathic pain, and cancer pain. Sixty-six cases were completed in all trials, of which 315 were test drugs and 15 were control drugs. The trials were divided into single doses, 3 days and 1 to 2 weeks doses of 10 to 20 μg each. Results The scorpion venom has the exact analgesic effect and the analgesic intensity is moderately lower. After 15 to 30 minutes after injection, the peak time was about 2 hours and the duration was 4 to 6 hours. Adverse reactions were dizziness, stomach discomfort, nausea, constipation, and pruritus. The incidence was low; there was no effect on respiration, blood pressure, and heart rate, and there was no effect on liver and kidney function. Conclusion Husu injection is a safe and effective drug for controlling moderate pain