十复生胶囊用于海洛因依赖者脱毒治疗多中心临床试验

目的:应用十复生胶囊对海洛因依赖者进行脱毒治疗,评价其临床脱毒效果及安全性。方法:采用随机双盲双模拟对照试验及开放试验设计,对照药为洛非西定。病例临床观察指标有戒断症状评分、HAMA焦虑评分;脱毒药效主要评价指标为戒断症状总分逐日变化,次要评价指标有戒断症状总分逐日减分率、有效率、焦虑量表评定等。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:共完成340例,其中对照试验140例(十复生和洛非西定各70例)和十复生开放试验200例。十复生胶囊10d脱毒治疗显示,该药控制戒断症状逐日减分总体效果及焦虑量表减分效果等均确切。与洛非西定比较,二者脱毒药效差异无统计学意义。不良反应轻微,主要有头晕、恶心、呕吐等,对血压、呼吸、心率无明显影响,对肝肾功能无影响。结论:十复生对海洛因依赖者有确切的脱毒效果,不良反应较轻。

MULTI- CENTERED CLINICAL TRIAL OF SHIFUSHENG CAPSULE FOR THE MANAGEMENT OF HEROIN WITHDRAWAL

Objective:To evaluate the efficacy and safety of Shifusheng capsule,a traditional Chinese medicine for the withdrawal syndrome of heroin addicts. Methods:Multi - centered clinical trail,including randomized,double blind and open study,was conducted,and lofexidine was used as a reference drug. The scales for withdrawal symptoms and HAMA were adopted for the evaluation of the efficacy to every patient. The reduction of daily scores of withdrawal symptoms was served as the primary effective index for treatment,the reduction rate of sum scores for withdrawal symptoms,effective rate,and the scores for HAMA were treated as the secondary effective index. Side effects were observed. Routine blood and urine test,ECG,and biochemistry test of blood were made. Results:Totally 340 patients were treated with Shifusheng capsule or lofexidine (140 patients participated in the control study,200 patients in the open study). Shifusheng capsule group showed definite efficacy for the reduction of sum scores of withdrawal symptoms,and HAMA,showing no significant differences (P>0.05) compared with lofexidine group. In Shifusheng capsule group,slight adverse drug reactions including dizziness,nausea,vomiting, etc. were observed,however, there was no significant difference in blood pressure,respiration,heart rate and routine blood and urine test,ECG,and biochemistry test of blood in pre and after treatment.Conclusion:Shifusheng capsule is effective in the treatment of withdrawal syndrome of heroin addicts and produces fewer and mild side effects.