奎硫平与氯丙嗪治疗精神分裂症的多中心随机双盲对照试验

A Comparison Study on Efficacy and Safety of Quetiapine and Chlorpromazine in The Treatment of Schizophrenia

目的:评价富马酸奎硫平治疗精神分裂症的疗效和安全性,并与经典抗精神病药氯丙嗪对照。方法:本研究采用多中心、随机平行、双盲双模拟对照试验方法。共入组符合研究方案的病例237例,奎硫平组119例,氯丙嗪组118例。两组药物剂量均为每天300～750mg。结果:两组的主要疗效指标阳性和阴性症状量表(PANSS)、简明精神病量表(BPRS)评分在治疗结束时与基线比较均有显著下降(P<0.01);根据PANSS减分率评定临床总有效率,奎硫平组的有效率为61.61％,氯丙嗪组的有效率为64.81％,两组之间无显著性差异;奎硫平组的药物不良反应发生率为44.54％,氯丙嗪组的发生率是76.27％。其中以震颤、肌紧张和静坐不能等明显少于对照组;实验室检查两组均无严重异常。结论:富马酸奎硫平是一种新的安全有效的抗精神病药物。

OBJECTIVE: To evaluate efficacy and safety of quetiapine in the treatment ctof schizophrenia patients in comparison with the chlorpromazine. METHOD: Design of a multi-center, randomized, double blind and double dummy, positive control study was conducted. Two hundred thirty seven patients who met inclusion and exclusion criteria were enrolled. There were 119 cases in quetiapine group, and 118 cases in chlorpromazine group. The dose is 300-750 mg once a day in two groups. RESULTS: Both groups endpoint positive and negative symptomes scale(PANSS) and brief psychiatry rating scale(BPRS) score reduced significantly in comparison with the baseline in both (P<0.01). By the PANSS score reduction rate, the clinical effectiveness rate is: quetiapine was 61.61% and chlorpromazine was 64.81%. The incidence of side effect is: quetiapine was 44.54 % and chlorpromazine was 76.27%. The side effects in quetiapine group are less than chlorpromazine group, especially in tremor, muscular tension, akathisia, etc. No severe abnormal laboratory finding was found during the treatment in two groups. CONCLUSION: Quetiapine is an effective and safe atypical antipsychotics for schizophrenia.