氨磺必利与利培酮治疗首发精神分裂症的随机双盲双模拟平行对照试验

目的：探讨氨磺必利与利培酮治疗精神分裂症的疗效及安全性。方法：采用随机、双盲、双模拟、平行对照试验方法,将34例符合诊断标准的首发精神分裂症患者随机分为氨磺必利组和利培酮组,每组17例。氨磺必利和利培酮的治疗剂量分别为800～1 200 mg·d~（-1）和2～6 mg·d~（-1）。疗程均为8周。于治疗前及治疗第1,2,4,8周末采用阳性和阴性症状评定量表（PANSS）评定疗效,采用治疗中出现的症状量表（TESS）及实验室检查来评价安全性。结果：治疗后第2,4,8周末,两组PANSS总分较治疗前均显著降低（P〈0.05）;氨磺必利组和利培酮组总有效率分别为88.2%和82.4%,差异无统计学意义（P〉0.05）。两组不良反应发生率比较差异亦无统计学意义（P〉0.05）。结论：氨磺必利和利培酮对治疗精神分裂症的疗效相当,不良反应轻,值得临床应用。

Parallel Control Method with Random Double-blind and Double-simulation in Treatment with Amisulpride and Risperidone of First-onset Schizophrenia

Objective:To explore the efficacy and safety of amisulpride and risperidone in treatment of schizophrenia. Methods:A randomized,double blind,double-dummy,parallel controlled clinical trial was conducted.The 34 cases of first episode schizophrenia patients met the diagnostic criteria were randomly divided into amisulpride group and risperidone group,17 cases in each group.The doses range of amisulpride and risperidone were 800-1200 mg and 2-6 mg per day, respectively.The treatment was 8 weeks.The efficacy and adverse events were assessed with the Positive and Negative Symptom Scale(PANSS),Treatment Emergent Symptom ScaJe(TESS) and the laboratory tests before and at 1st,2nd, 4th,8th weekend after treatment.Results:The scores of PANSS in the two groups decreased significantly compared with the baseline at 2nd,4th,8th weekend after treatment(P < 0.05 );The efficacy rates of amisulpride group and risperidone group were 88.2%and 82.4%,respectively.There was no significant difference between two groups in improvement rate and side effect(P>0.05).Conclusion:Amisulpride is as effective as risperidone for the treatment of schizophrenia with fewer side effects and worth clinical application.