参附脱毒胶囊与可乐定控制海洛因依赖戒断症状的随机双盲对照研究

目的·· :客观评价参附脱毒胶囊对海洛因依赖的脱毒效应、不良反应及安全度。方法·· :按照卫生部原药政管理局制定的《抗阿片类戒断症状药物临床试验指导原则》 ,采用随机双盲对照临床研究。纳入病例临床观察指标为《戒断症状评定量表》、《HAMA焦虑评定量表》、《不良反应评定量表》 ;实验室检查指标为血尿常规、肝肾功能、心电图、尿液吗啡定性测定。结果·· :纳入病例92例。随机进入参附脱毒胶囊组33例 ,可乐定组30例 ,安慰剂组29例。参附脱毒胶囊组与可乐定组类似 ,在治疗的d1、d2、d3戒断症状快速减轻 (P<0.05) ,呈现出明显的时效关系。在治疗的d3 ,参附脱毒胶囊控制戒断症状的有效率达57.3 % ,可乐定的有效率为46.7 % ,均明显大于安慰剂的有效率6.9 %(P<0.001)。疗程结束时吗啡尿检呈阴性反应 ,停药后戒断症状无反复。参附脱毒胶囊组的不良反应总分、对血压的影响明显较可乐定为低 (P<0.05)。未发现对肝、肾功能、血尿常规的明显影响。结论··:参附脱毒胶囊控制戒断症状的疗效肯定 ,与可乐定疗效相当。不良反应主要为口干、思睡、头晕 ,多为轻度反应 ,无需处理自行消失。在治疗的初期应给予充分剂量 ,每次1.2-1.6g ,每日3次为宜。d4起可逐日减量

DOUBLE BLIND AND RANDOMIZED CLINICAL TRAIL ON THE EFFECT OF SHENFUTUODU CAPSULE COMPARED WITH CLONIDINE ON WITHDRAWAL SYNDROME OF HEROIN ADDICTS

Objective: To evaluate the curative effect and the safety of Shenfutuodu capsule on withdrawal syndrome of heroin addicts. Methods: Randomized, double blind clinical trail was adopted;the scale for withdrawal symptoms, HAMA, the scale for side effect were evaluated to every patient; the routine blood and urine test, ECG, and the biochemistry test of blood were carried out. Results: 33 patients were treated with Shenfutuodu capsule, 30 patients were treated with clonidine, 29 patients were treated with placebo. The groups of Shenfutuodu capsule and clonidine showed significant reduction of the scores of withdrawal symptoms and HAMA. Compared with clonidine group , the group of Shenfu- tuodu capsule showed not only lower score of side effects but also lower reduction of blood pressure. Conclusion: Shenfutuodu capsule is effective in the treatment of withdrawal syndrome of heroin addicts and produces fewer and mild side effects.