阿立哌唑治疗精神分裂症的多中心随机双盲对照试验

目的:评价阿立哌唑治疗精神分裂症的疗效及安全性。方法:采用多中心随机双盲双模拟、阳性药平行对照的方法。以利司哌酮(昔名利培酮)为对照,受试者分别口服阿立哌唑10~30 mg.d-1与利司哌酮2~6 mg.d-1,疗程42 d。结果:共收集精神分裂症病人222例,其中阿立哌唑组111例与利司哌酮组111例。治疗结束时,2组PANSS总分与BPRS总分较治疗前均显著降低(P<0.01);PANSS总分减分率阿立哌唑组(65±s28)%,利司哌酮组为(67±26)%,差异无显著意义(P>0.05)。临床总有效率:阿立哌唑组为77.0%,利司哌酮组为79.2%,2组比较差异无显著意义(P>0.05)。阿立哌唑组常见的不良反应为:静坐不能、震颤、失眠、心动过速,不良反应较利司哌酮组少。结论:阿立哌唑治疗精神分裂症的疗效与利司哌酮相似,不良反应较利司哌酮为少,是一种安全而有效的抗精神病药。

A multicenter, randomized and double-blind controlled clinical trial of aripiprazole in treatment of schizophrenia

AIM: To evaluate the efficacy and safety of aripiprazole in the treatment of schizophrenia.METHODS: A multicenter,randomized,double-blind,double dummy,positive drug parallel controlled clinical trial was conducted for treating schizophrenia.The experimental group was given aripiprazole 10-(30 mg·d~(-1)) and the control group was given with risperidone 2-6 mg·d~(-1) during 42 d treatment period.RESULTS: Two hundered and twenty-two patients with schizophrenia were enrolled including 111 patients were in the experimental group and 111 patients in the control group.The scores of PANSS and BPRS at the endpoint were significantly reduced in comparison with the baseline before the treatmentin both groups(P<(0.01),) and the decreasing rates on PANSS were(65±(s 28) %) in experimental group and(67±26) % in control group,with no significant difference(P>(0.05)).The efficacy rates were 77.0 % in experimental group and 79.2 % in the control group,there was no significant difference between two group(P>(0.05)). Adverse reactions were fewer in experimental group than in control group,including akathisia,tremor,insomnia,tachycardia and constipation.CONCLUSION: Aripiprazole is an effective and safe new agent for the treatment of schizophrenia.