齐拉西酮治疗精神分裂症的随机、双盲、双模拟、多中心研究

目的:评价齐拉西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、多中心研究。齐拉西酮组和氯丙嗪组各120例,分别给予齐拉西酮和氯丙嗪及与齐拉西酮和氯丙嗪外观相似的模拟药,剂量从20mg·d-1和50mg·d-1开始,wk 2～6调节至60～160 mg·d-1和250～600mg·d-1。均分2次口服,观察期为6wk,采用阳性和阴性症状量表(PANSS),简明精神病量表(BPRS)及临床总体印象量表(CGI)评价疗效。通过体检、实验室检查、心电图检查及其他不良事件的收集评价安全性。结果:全分析集(FAS)和安全集(SS)统计共238例,试验组120例,对照组118例。符合方案集(PP)205例,试验组112例,对照组93例。根据FAS人群分析,试验组的疗效不劣于对照组。2组PANSS评分及减分无差异。试验组治疗有效率为62.5％,对照组为58.5％(P>0.05)。试验组不良事件发生率为66.7％,不良反应发生率为62.5％;对照组分别为66.1％和63.6％(P>O.05),2组均未出现严重不良事件。但对照组肝功能异常发生率(5.9％)比试验组(1.7％)高,差异有统计学意义(P<0.05)。结论:齐拉西酮用于精神分裂症的治疗是有效而安全的,治疗剂量范围为60-160mg·d-1,起始治疗剂量为20mg·d-1(进餐时服)。

Ziprasidone in treatment of schizophrenia: a double blind, randomized, controlled, parallel group, and multicenter study

AIM: To evaluate the efficacy and safety of ziprasidone in the treatment of schizophrenia. METHODS: A double blind, double dummy, randomized, controlled, parallel group, and multicenter trial was carried out in ziprasidone and chlorpromazine groups with 120 patients in each. The observation duration was 6 wk. The dose in two groups were initially 60 - 160 mg·d-1 and 250 - 600 mg·d-1 respectively with twice oral adminstrations for wk 2 - 6. PANSS, BPRS and CGI were used as the tools to evaluate the efficacy, while physical examination, lab test, EKG and other adverse events were utilized to evaluate the safety. RESULTS: Two hundred and forty subjects were enrolled with 120 for ziprasidone and clopromazine group respectively. FAS plus SS was 238 patients, including 120 patients in ziprasidone group and 118 patients in clopromazine group. The non-inferior test showed that the efficacy of ziprasidone was not inferior to that of chlopromazine group. The differences of PANSS reduction between the two groups was not significant. The response rates in two groups were 62.5 % vs 58.5 % (P > 0.05), respectively. The rates of adverse event and adverse reaction in the two group were 66.7 % vs 66.1 % and 62.5 % vs 63.6 %, respectively. The common adverse events in ziprasidone group were EPS, upper respiratory infection, constipation, insomnia, abnormal ECG, vomiting, somnia, dizziness. CONCLUSION: Ziprasidone is effective and safety in the treatment of schizophrenia. The daily dose range is from 60 mg·d-1 to 160 mg·d-1, po, bid.