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中药灵益胶囊是用于控制阿片类药物依赖戒断症状的复方中药制剂。已被卫生部批准进行临床试验。本研究采用随机双盲和开放多中心临床试验,共完成330例海洛因依赖者的脱毒效应评定。结果发现灵益胶囊于治疗的第3日控制海洛因戒断症状的显著好转率为71.43%,可乐定为58.47%,两组结果类似,安慰剂组仅为10.53%。灵益胶囊与可乐定的疗效显著优于安慰剂(X2=22.8298,P=0.0000)。疗程结束时戒断症状无反复。提示灵益胶囊具有明显的控制阿片类戒断症状的效应,其总体疗效与可乐定相当。灵益胶囊治疗中,其不良反应明显低于可乐定组(P<0.05),与安慰剂类似(P>0.05)。开放性试验显示,灵益胶囊的疗效与不良反应出现情况与双盲试验类似。
Chinese medicine Lingyi capsule is a compound traditional Chinese medicine preparation for controlling withdrawal symptoms of opioid dependence. Has been approved by the Ministry of Health for clinical trials. In this study, randomized double-blind and open multi-center clinical trials were used to assess the detoxification effects of 330 heroin addicts. As a result, it was found that the significant improvement rate of the control of heroin withdrawal symptoms at the third day of treatment was 71.43% and 58.47% for clonidine. The two groups had similar results, and the placebo group was only 10.53%. The efficacy of Lingyi capsules and clonidine was significantly better than placebo (X2=22.8298, P=0.0000). No withdrawal symptoms at the end of treatment. It is suggested that Lingyi Capsule has obvious effect of controlling opioid withdrawal symptoms, and its overall curative effect is comparable to that of clonidine. In the treatment of Lingyi capsule, the adverse reaction was significantly lower than that of clonidine group (P<0.05), similar to placebo (P>0.05). Open trials showed that the efficacy and adverse reactions of Lingyi capsules were similar to double-blind trials.