齐拉西酮注射剂与氟哌啶醇注射剂治疗精神分裂症急性期患者的对照研究

目的比较齐拉西酮注射剂与氟哌啶醇注射剂治疗精神分裂症急性期的疗效与副作用。方法选用齐拉西酮注射剂与氟哌啶醇注射剂,将75例患者分至齐拉西酮组（n=38）和氟哌啶醇组（n=37）,进行为期5天的治疗。两组分别完成34例和33例。在治疗前及治疗后采用阳性与阴性综合征量表（PANSS）、修改版外显攻击行为量表（MOAS）、临床总体印度量表（CG I）、不良反应量表（TESS）评定疗效及药物不良反应。治疗前进行基线心电图测定,与治疗后QTc间期比较。结果齐拉西酮组和氟哌啶醇组治疗前后PANSS阳性症状量表因子分、MOAS加权总分减分率相当;CG I评分达到好转与以上者分别为25例（73.5%）、26例（78.8%）;齐拉西酮组不良反应主要为失眠10例（29.4%）,QTc间期延长3例（7.9%）,心律失常2例（5.3%）。氟哌啶醇组不良反应主要为锥体外系反应16例（48.5%）,无QTc间期延长者。结论齐拉西酮注射剂与氟哌啶醇注射剂对治疗精神分裂症急性期患者的疗效相当,但应高度重视齐拉西酮对心脏不良反应,特别是心律失常及QTc间期的延长。

Comparative study of ziprasidone versus haloperidol injection in the treatment of schizophrenia in acute phase

Objective：To compare the efficacy and side effects of ziprasidone injection versus haloperidol injection in the treatment of schizophrenia in acute phase.Methods： Seventy-five patients were divided into ziprasidone group（n=38） or haloperidol group（n=37） using ziprasidone or haloperidol injection for a period of five days.The two group had completed 34 and 33 cases,respectively.They were assessed using positive and negative syndrome scale（PANSS）,modified overt aggression scale（MOAS）,clinical global impression（CGI） and an adverse reactions scale（TESS）.We examined the baseline ECGs and compared pre-and post-treatment QTc intervals.Results：PANSS positive symptoms scale factors score and MOAS weighted score reduction rate were similar pre-and post-treatment between ziprasidone group and haloperidol group.Twenty-five（73.5%） and 26（78.8%） patients achieved improvement or better in CGI score in,ziprasidone group and haloperidol group respectively.Main adverse reactions in ziprasidone group were insomnia（n=10,29.4%）,QTc interval prolongation（n=3,7.89%） and arrhythmia（n=2,5.26%）.Main adverse reaction in haloperidol group was extrapyramidal reaction（n=16,48.5%）,with no QTc interval prolongation.Conclusion：Efficacy of ziprasidone and haloperidol injection was comparable in acute phase of schizophrenia.However,attention should be paid to the cardiac adverse reaction of ziprasidone,particularly arrhythmia and QTc interval prologation.