齐拉西酮与利培酮治疗首发精神分裂症疗效与安全性的系统评价

Systematic review of the efficacy and safety of Ziprasidone and Risperidone in the treatment of first episode schizophrenia

目的:系统评价齐拉西酮与利培酮治疗首发精神分裂症患者的疗效与安全性,为临床治疗提供循证参考。方法:计算机检索Pub Med、EMbase、EBSCO、CBM、CNKI、VIP和Wan Fang Data,收集齐拉西酮(试验组)对比利培酮(对照组)治疗首发精神分裂症患者的随机对照试验(RCT),对符合纳入标准的临床研究进行资料提取和质量评价后,采用Rev Man 5.0统计软件进行Meta分析。结果:共纳入29篇RCT,合计2 424例患者。Meta分析结果显示,试验组患者痊愈率和总显效率与对照组比较,差异无统计学意义(P>0.05);不良反应方面,试验组发生体重增加[P<0.001,OR合并=0.19,95%CI=(0.13,0.29)]、泌乳素升高[P<0.001,OR合并=0.08,95%CI=(0.05,0.14)]及锥体外系反应[P=0.000 7,OR合并=0.37,95%CI=(0.21,0.66)]均低于对照组,差异有统计学意义,试验组发生心电图异常[P=0.002,OR合并=2.59,95%CI=(1.44,4.65)]及头痛[P=0.02,OR合并=1.85,95%CI=(1.11,3.11)]高于对照组,差异有统计学意义。结论:两药治疗首发精神分裂症疗效相当,齐拉西酮发生锥体外系反应和代谢紊乱较利培酮少,而心电图异常与头痛的发生率较利培酮多。受纳入研究方法学质量和样本量限制,该结论有待更多设计严格、长期随访的大样本RCT加以验证。

ObjectiveTo systematically review the efficacy and safety of Ziprasidone versus Risperidone in the treatment of firstepisodeschizophrenia, and provide evidence-based reference for clinical treatment. Methods ： Searched the clinical control study of the Ziprasidoneand Risperidone in the treatment of first-episode schizophrenia by pubmed, EM base, EBSCO, CBM, CNKI, VIP and WanFang databank. After quality evaluation and data extract, meta-analysis was performed by using Rev Man 5 .0 statistics software. Results： A totalof 29 RCT were included involving 2 424 patients. Results of meta-analysis showed that the efficacy rate and the total efficiency rate of Ziprasidoneand Risperidone had no significant difference（ P 〉 0. 05 ） ; In the adverse drug reactions, the incidences of extrapyramidal reactions[P = 0. 000 1 yOR = 0 .3 1 ,95% CI = （0 .2 1 ,0 .6 6 ） ] ,the incidences of weight gain[P 〈0. 001, OS = 0. 19,95% CI= （0. 13,0. 2 9 ）]and the incidences of prolactin increasing[ P 〈0. 001, OR = 0. 08 ,95% CI = （0. 05,0. 14） ] of control group were significantly more thantest group with statistically significant difference ; the incidences of headache [ P = 0. 02, OR = 1 .8 5 ,9 5 % C I= （1. 11,3. 11） ] and the incidencesof electrocardiographic abnormality [ P = 0. 002, OR = 2. 5 9 ,95% CI= （1 .4 4 ,4 . 65） ] were significantly lower than test group withstatistically significant difference. Conclusion： The efficacy of the Ziprasidone and Risperidone in the treatment of first episode schizophreniais sim ilar,the incidences of extrapyramidal reaction metabolic disorders less risperidone, and the incidences of headache and abnormalelectrocardiogram more than risperidone. Because of limited method logical quality and sample size,it remains to be further verifiedwith more rigorously designed and long-term follow-up of large-scale RCT.