齐拉西酮治疗躁狂发作激越行为的随机对照研究

A Control Study on Ziprasidone and Haloperidol in the Treatment of Agitation of Acute Mania Episode

目的:评价齐拉西酮治疗躁狂发作激越行为的疗效和安全性。方法:采用数字随机分组对照的方法,对符合美国精神障碍诊断与统计手册第4版(DSM-Ⅳ)双相Ⅰ型躁狂发作患者70例,按照1∶1的比例随机分为齐拉西酮组35例与氟哌啶醇组35例,齐拉西酮每日总量不超过160mg,氟哌啶醇每日总量不超过30mg。于治疗前、治疗后24h、48h、72h及1周末采用PANSS的兴奋因子量表评定疗效,用副反应症状量表(TESS)评定安全性。结果:两组药物对患者的兴奋激越症状均能快速起效,各时点两组间减分无显著性差异,说明两种药物疗效相当。氟哌啶醇组锥体外系不良反应的比例显著高于齐拉西酮组(P<0.05),其余各项无显著差异。结论:齐拉西酮与氟哌啶醇治疗躁狂发作患者的激越症状均有明显疗效,但是齐拉西酮不良反应少。

Objective：The study evaluated the efficacy and safety of ziprasidone and haloperidol in the treatment of agitation of bipolarⅠdisorder acute mania episode.Methods：70patients met the criteria of DSM-Ⅳfor BipolarⅠdisorder acute manic episodes,and the score of PANSS-EC≥15,were randomly divided into two teams.35patients were given ziprasidone,other 35patients were given haloperidol.The total dose of ziprasidone was no more than 160mg/d,haloperidol was no more than 30mg/d.Efficacy was assessed with the score of PANSS-EC at baseline,24h,48h,72hand 1 week.Safety was assessed with TESS.Results：Both ziprasidone and haloperidol produced rapid,sustained improvements relative to baseline.The efficacy was no significant difference between the two teams at 24h,48h,72hand 1 week.The incidence of EPS in the team of haloperidol was significant higher than the team of ziprasidone（P0.05）.There was no significant difference in the incidence of other side effects.Conclusion：Both Ziprasidone and haloperidol were effective to the agitation of acute mania,but Ziprasidone was better.