正通宁与可乐定治疗海洛因戒断症状的双盲对照研究

目的 :··考察正通宁颗粒冲剂抗阿片类戒断症状的效能。方法·· :对于符合DSM—Ⅳ药物依赖及阿片类戒断反应诊断标准的216例阿片类依赖者随机分为正通宁治疗组 ,可乐定治疗组和安慰剂治疗组 ,采用双盲双模拟的给药方法 ,进行为期10d的对照研究。结果··:从治疗10d不同时点戒断症状总分的观察结果分析 ,正通宁组的抗海洛因戒断症状作用优于安慰剂组和可乐定组。从对戒断综合征中具代表性症状的分析结果可见 ,正通宁对于缓解戒断症状中的哈欠、骨肌肉疼痛和失眠的作用优于可乐定组。不良反应总分在整个用药过程中与安慰剂组无显著性差异。治疗过程中出现频率较高的不良反应有口干、视物模糊、乏力、头晕、嗜睡、困倦、恶心、呕吐、心慌等。脱毒治疗最高使用剂量以120 -180g.d -1 ,分4次服用为宜。结论··:正通宁颗粒冲剂抗阿片类戒断症状的疗效良好 ,作用肯定 ,不良反应较轻 ,适用于阿片类的脱毒治疗

A DOUBLE-BLIND CLINICAL TRIAL OF ZHENG TONGNING VS CLONIDINE HYDROCHLORIDE IN THE TREATMENT OF HEROIN WITHDRAWAL SYMPTOMS

Objective: To evaluate the efficacy of Zheng Tongning, a Chinese herbal compound, in alleviating opiate withdrawal symptoms among heroin addicts. Method: 216 patients with heroin addiction were randomly assigned to double-blind groups of Zheng Tongning, clonidine hydrochloride and placebo. All of the subjects were treated for 10 days. The withdrawal symptoms and adverse drug reactions were recorded daily, Result: Compared with clonidine and placebo, Zheng Tongning was better in rapidly alleviating withdrawal symptoms, particularly in relieving yawning, muscle and bone pains and insomnia. The adverse drug reactions of Zheng Tongning were mouth dry, blurred version, weakness, dizziness, somnolence, drowsiness, vomiting, nausea and palpitation. The proper daily dose was titrated from 120 g to 180 g, and administered four times a day. Conclusion: Zheng Tongning is effective in the treatment of opiate withdrawal symptoms with less and light adverse drug reactions.