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目的:评价喹硫平和氟哌啶醇治疗精神分裂症患者急性期兴奋激越对QTc间期的影响.方法:本研究为多中心随机对照研究.选取80例符合ICD-10精神分裂症诊断标准并处于急性兴奋激越状态的患者,按1:1随机分为喹硫平组(n=40)和氟哌啶醇组(n=40),接受4周的喹硫平或氟哌啶醇治疗.基线和治疗第4周末分别检查心电图和血清钾钠氯水平.结果:治疗4周末,氟哌啶醇组的QTc间期增加(22.5±42.7) ms,而喹硫平组则缩短(-5.0±35.6)ms,两组间差异具有统计学意义(P=0.003).低剂量(≤10 mg)和高剂量(＞ 10 mg)氟哌啶醇治疗对QTc间期影响不同,两者的QTc间期增加分别为(5.6±29.0)和(38.0±48.2)ms,差异具有统计学意义(P =0.032).治疗第4周末,氟哌啶醇组6例(15％)患者QTc间期在原基础上增加超过60 ms,其中1例男性患者QTc间期达到450 ms,喹硫平组患者未见恶性心律异常的QTc间期延长.结论:口服氟哌啶醇单药治疗精神分裂症急性期兴奋激越患者,QTc间期明显延长,口服喹硫平治疗未发现对QTc间期存在明显影响,可能更适合在精神分裂症急性期兴奋激越患者中使用.“,”Objective:To evaluate the side effects of quetiapine and haloperidol on QTc interval in the treatment of acute excitement and agitation symptoms in patients with schizophrenia.Methods:Totally 80 schizophrenic patients diagnosed according to the International Classification of Diseases and Related Health Problems,Tenth Revision (ICD-10) criteria were enrolled in a 4-week multi-center clinical trial.Of the patients,40 were treated with quetiapine and 40 with haloperidol.Electrocardiogram (ECG),and serum levels of potassium,sodium and chloride were measured at baseline and endpoint (4 week).Results:On the 4th week,the changes in QTc interval were [(22.5 ± 42.7) vs (-5.0 ± 35.6) ms] in haloperidol and quetiapine groups (P =0.003).The changes in QTc interval were [(5.6 ±29.0) vs (38.0 ±48.2) ms] in patients taking low (≤ 10 mg) and high doses (＞ 10 mg) of haloperidol.At the end of 4th week,6 patients (15％) had prolonged QTc interval than 60 ms in haloperidol group,and one male patient's QTc interval was increased to 450 ms.Conclusion:Haloperidol causes QTc interval prolongation more than quetiapine,and quetiapine has no remarkable effect on QTc interval.These findings suggest that quetiapine is safe on QTc interval in the acute management of psychotic agitation in schizophrenic patients.