利培酮(单克)与利培酮(维思通)治疗精神分裂症的对照研究

A comparative study on the efficacy of risperidone(Danke and Weisitong) in the treatment of patients with schizophrenia

目的:探讨国产利培酮(商品名单克)治疗精神分裂症的疗效和安全性。方法:205例符合中国精神障碍分类与诊断标准第三版诊断标准的精神分裂症病人随机分为两组,分别给予利培酮(商品名单克)和利培酮(商品名维思通)治疗6周,采用阳性症状和阴性症状量表评定临床疗效,并考察不良反应发生情况。结果:治疗6周的疗效相当,单克组和维思通组的显效率分别为82.52%(85/103)和80.39%(82/102),差异无显著性(P>0.05)。不良反应中锥体外系反应(肌强直、震颤、静坐不能)的发生率单克组略低于维思通组(分别为34.95%及37.25%),但无显著性差异(P>0.05)。结论:利培酮(单克)和利培酮(维思通)对治疗精神分裂症的疗效相当,不良反应发生率相近。

Objective：To compare the efficacy and safety of risperidone（Danke） and risperidone（Weisitong） in the treatment of patients with schizophrenia. Methods： Two hundred and five schizophrenic patients who met Chinese Classification and Diagnostic Criteria of Mental Disorders Version 3 （CCMD-3） were randomly divided into risperidone（Danke） group and risperidone（Weisitong） group. The treatment was continued for 6 weeks. Positive and negative symptom scale （PANSS） was used to evaluate the efficacy and the side effects were observed. Results：The improvement rates of Danke and Weisitong were 82.52% （85/103）and 80.39 % （82/102）, respectively. There was no significant difference in effectiveness between the two groups （P〉0.05）. The rates of extrapyramidal side effects including muscle rigidity, tremor and akathisia in Danke group were lower than those in Weisitong group （34.95% vs 37.25% ）, but there was no significant difference in the incidence of adverse drug reac tions （P〉0.05）. Conclusion：The efficacy and the rate of adverse effects of Danke in the treatment of the patients with schizophrenia are similar to those of Weisitong.