国产齐拉西酮与氯丙嗪治疗精神分裂症的随机对照研究

A Randomized, Controlled Study of Domestic Ziprasidone and Chlorpromazine in the Treatment of Schizophrenia

目的评价国产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、氯丙嗪平行对照研究。齐拉西酮组和氯丙嗪组各24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，剂量分别为60～160mg／d和250～600mg/d。药物均2次／d口服，观察期为6周。于治疗前和治疗第1、2、4、6周末采用阳性和阴性综合征量表（PANSS），简明精神病量表（BPRS）及临床总体印象量表（CG0评价疗效，通过体检、实验室检查、心电图检查及收集其他不良事件评价安全性。结果2组PANSS减分无明显差异。试验组的有效率（62．5％）在数值上高于对照组的（33．3％）（X2=6．3236，P=0．0969）；试验组不良事件发生率和不良反应发生率（66．7％和58．3％）在数值上低于对照组的（79．2％和75．0％），但上述组间差异都无统计学意义（X2=0．9495，P=0．3229和X2=1．5000，P=0．2207）。结论国产齐拉西酮治疗精神分裂症是有效而安全的。

Objective To evaluate the efficacy and safety of domestic ziprasidone in the treatment of schizophrenia. Methods A double blind, double dummy, randomized, controlled, parallel group trial was carried out in ziprasidone and chlorpromazine groups with 24 patients in each. The observation duration was 6 weeks. The doses in 2 groups were initially 60- 160mg/d and 250~600mg/d respectively with twice oral administrations for week 1, 2, 4, 6. PANSS, BPRS and CGI were used as the tools to evaluate the efficacy, while physical examination, lab test, electrocardiogram and other adverse events were utilized to evaluate the safety. Results The differences of PANSS reduction between the 2 groups were not significant. The response rates in two groups were 62.5% vs 33.3% （X2=6.3236, P=0.0969）. The rates of adverse event and adverse reaction in the two group were 66.7% vs 79.2% and 58.3% vs 75.0% （X2=0.9495, P=0.3229 vs X2= 1.5000, P=0.2207）. Concision Domestic ziprasidone is effective and safety in the treatment of schizophrenia.