喹硫平和氟哌啶醇治疗精神分裂症急性期兴奋激越对QTc间期的影响  

Effect of quetiapine and haloperidol on QTc interval in treating schizophrenic patients with excitement and agitation

作　　者：梁英[1] 苏允爱[1] 黄继忠[2] 唐茂芹[3] 栗克清[4] 杨甫德[5] 司天梅[1] 

机构地区：[1]北京大学精神卫生研究所,北京100191 [2]上海市精神卫生中心,上海200030 [3]山东省精神卫生中心,济南250014 [4]河北省精神卫生中心,保定071000 [5]北京回龙观医院,北京100096

出　　处：《中国新药杂志》2013年第16期1886-1889,1894,共5页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(2011ZX09302-004)

摘　　要：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 schizo- phrenic 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 and chloride interval were were measured at [ （22.5 ±42.7） baseline and endpoi vs （-5.0±35.6） nt （4 week）. Results： On the 4th week, ms] in haloperidol and quetiapine groups po Lhe （e tasslum changes = 0.003 sodium in QTc ）. The changes in QTc interval were [（5.6±29.0） vs （38.0±48.2） msl in patients taking low （≤10 mg） and high doses （ 〉 10 rag） 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 cau- ses QTc findings phrenic interval prolongation more than suggest that quetiapine is safe patients.

关 键 词：喹硫平 氟哌啶醇 精神分裂症 激越 QTC间期 

分 类 号：R971.41[医药卫生—药品]