阿立哌唑与利培酮治疗精神分裂症的随机双盲多中心对照研究

目的 评价阿立哌唑治疗精神分裂症的疗效及安全性.方法 采用随机双盲多中心对照研究方法.240例精神分裂症患者随机分为:阿立哌唑组120例,剂量10～30 mg/d;利培酮组120例,剂量2～6 mg/d.疗程6周.以阳性和阴性症状量表(PANSS)总分变化和有效率为疗效指标.结果 治疗第6周末,阿立哌唑组PANSS总分从基线的85.12分降至52.26分,平均减分32.86分;利培酮组从基线的86.89分降至50.30分,平均减分36.58分;两组的差异无统计学意义(F=1.61,P=0.206).阿立哌唑组有效率为64.3%,利培酮组为68.9%,两组的差异没有统计学意义(X2=1.00,P=0.316).阿立哌唑组和利培酮组相关不良事件发生率分别为65.0%和73.3%.阿立哌唑组对体质量(F=4.535,P=0.034)和血清催乳素(F=33.576,P=0.000)的影响较利培酮组小.结论 阿立哌唑治疗精神分裂症的疗效与利培酮相当,不良反应相似;但阿立哌唑较少引起患者体质量增加,对血清催乳素水平无影响.

Efficacy and safety of aripiprazole in the treatment of schizophrenia: a randomized, double-blind, risperidone controlled, multicenter study

Objective To evaluate the efficacy and safety of aripiprazole in treatment of patientswith acute exacerbation of schizophrenia.Methods A randomized,double-blind,multi-center,controlled clinical trim was conducted.All subjects(n=240)received 6 weeks treatment with either aripiprazole(n=120)or fispefidone(n=120),with the dosage of 10-30 mg/d and 2-6 ms/d respectively.The main efficacy measure was the change in total score of the PANSS and response rate.Results The mean reduction score of PANSS were 32.86 in aripiprazole and 36.58 in risperidone at the endpoint of treatment,and the clinical response rates were 64.3%and 68.9%respectively.There were no significant differences between both groups(F=1.61,P=0.206)(x2=1.00,P=0.316).The incidence of adverse events was approximate in both the groups,with lower liability for weight gain and effects on serum prolactin level in aripiprazole than in fispefidone treatment(F=4.535,P=0.034;F=33.576,P=0.000).Conclusion The resuhs show that aripiprazole has similar therapeutic effect to risperidone in treatment of patients with acute exacerbation of schizophrenia.Aripiprazole is safe and well tolerated in Chinese population.