参附脱毒胶囊治疗海洛因依赖者戒断症状对照研究

EFFICACY COMPARISON OF SHENFUTUODU CAPSULES AND CLONIDINE ON TREATMENT OF HEROIN DEPENDENCE

目的·· :评价参附脱毒胶囊的脱毒效果、不良反应及安全性。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》 ,对参附脱毒胶囊与盐酸可乐定进行随机双盲对照研究。结果·· :参附脱毒胶囊组和可乐定组治疗d3的有效率分别为88.3 %和78.9 % ,戒断症状总分分别为322.84±s141.97和365.90±s127.35,均无统计学差异。参附脱毒胶囊组的不良反应总分16.07±s16.47 ,明显低于可乐定组(40.10±s30.72) ,P<0.01。两组治疗前后白细胞、肝、肾功能和心电图检查异常情况出现率经 χ2 检验差异无显著性。结论·· :参附脱毒胶囊的脱毒效果与可乐定相当 ;参附脱毒胶囊的不良反应发生率低、程度轻微 ,且临床使用安全 。

Objective: To evaluate the efficacy, side-effect, and safety of Shenfutuodu capsules, a traditional Chinese medicine,in the detoxification treatment of heroin dependence.Methods: A random double-blind study was carried out in Shenfutuodu and Clonidine treatment groups.Results: The efficacy rate of Shenfutuodu group and Clonidine group was 88.3% and 78.9%,respectively, the total withdrawal symptom scores were 322.84±s 141.97 and 365.90±s 127.35, respectively after three days treatment with no significant difference found between the two groups.The total scores of side effects of Shenfutuodu group (16.07±s 16.47) were fewer than those in Clonidine group (40.10±s 30.72), P<0.01.There were no significant differences on the abnormal rate of WBC,EEG,and liver and kidney pre and post treatment.Conclusion: The detoxification efficacy of Shenfutuodu was similar to clonidine in treating heroin dependence, but Shenfutuodu shows a fewer side-effects. Shenfutuodu is an effective and safe detoxification agent for heroin dependence.