氨磺必利与氯丙嗪对精神病患者心电图影响的对照研究
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摘要
目的探讨氨磺必利对精神病患者心电图(ECG)的影响。方法将符合入组标准的76例精神病患者随机分为氨磺必利治疗组和氯丙嗪治疗组,氨磺必利使用剂量为400~600 mg,bid,氯丙嗪剂量为200~300 mg,bid,疗程16周。在研究基线和治疗后第16周分别进行ECG检查,比较治疗前后T波改变,窦性心律失常(窦性心律不齐、窦性心动过速、窦性心动过缓),QTc异常(>450 ms)和其他各类传导阻滞、早搏等。结果治疗16周时,氨磺必利组有8例(21.6%)、氯丙嗪组有21例(53.8%)出现ECG异常,两组比较差异有统计学意义(P<0.01),两组QTc均值均延长(P<0.01),而氯丙嗪组比氨磺必利组QTc延长更明显(P<0.01)。两组患者服用药物剂量越高,ECG异常发生率均随治疗剂量增加而增高(P<0.01)。结论氨磺必利对ECG影响小,临床使用安全性较高。
Objective To explore the effect of amisulpride on the electrocardiographic(ECG) in psychotic patients.Methods 76 psychotic patients meeting the criteria were randomly assigned into two groups and treated with amisulpride(400 ~ 600 mg,bid) and chlorpromazine(200 ~ 300 mg,bid) respectively for 16 weeks.ECG was assessed at the baseline and the 16th week.T-wave change,sinus arrhythmia(sinus irregularity,sinus tachycardia,sinus bradycardia),abnormal QTc(more than 450 ms) and other abnormalities(all types of heart-blocks,premature beats and etc)were analyzed respectively.Results At the 16th week,8 cases(21.6%) in amisulpride group and 21 cases(53.8%) in chlorpromazine group developed ECG abnormalities,there was significant difference between the two groups(P <0.01).QTc mean valves in both two groups were extended(P < 0.01),but the change in chlorpromazine group was more obvious(P < 0.01).The higher doses taken the higher ECG abnormality incidence would be in both groups(P <0.01).Conclusion The effect of amisulpride on ECG is small and its security for clinical use is high.
Objective To explore the effect of amisulpride on the electrocardiographic(ECG) in psychotic patients.Methods 76 psychotic patients meeting the criteria were randomly assigned into two groups and treated with amisulpride(400 ~ 600 mg,bid) and chlorpromazine(200 ~ 300 mg,bid) respectively for 16 weeks.ECG was assessed at the baseline and the 16th week.T-wave change,sinus arrhythmia(sinus irregularity,sinus tachycardia,sinus bradycardia),abnormal QTc(more than 450 ms) and other abnormalities(all types of heart-blocks,premature beats and etc)were analyzed respectively.Results At the 16th week,8 cases(21.6%) in amisulpride group and 21 cases(53.8%) in chlorpromazine group developed ECG abnormalities,there was significant difference between the two groups(P <0.01).QTc mean valves in both two groups were extended(P < 0.01),but the change in chlorpromazine group was more obvious(P < 0.01).The higher doses taken the higher ECG abnormality incidence would be in both groups(P <0.01).Conclusion The effect of amisulpride on ECG is small and its security for clinical use is high.
引文
[1]程玉红,康江鹏,陈蔚,等.氨磺必利的合成[J].中国医药工业杂志,2011,42(11):801-803.
[2]陈妍,陈美娟.氨磺必利在精神分裂症中的研究进展[J].神经疾病与精神卫生,2011,11(1):83-85.
[3]范肖东.精神与行为障碍分类临床描述与诊断要点(ICD-10)[M].北京:人民卫生出版社,1993:70-106.
[4]Stephen B,Steven R,Warren S,et a1.Designing clinical research:an epidemionlogic approach[M].New York:Lippincott Williams&wilkins,2001:235-237.
[5]Komossa K,Rummel-Kluge C,Schwarz S,et a1.Amisulpride versus other atypical antipsychotics for schizophrenia[J].Cochrane Database Syst Rev,2010,(1):CD006624.
[6]黄素培,张瑞岭,王来海,等.氨磺必利的药理学进展与临床应用评价[J].中国医院用药评价与分析,2011,11(8):679-683.
[7]刘林晶,刘家洪,唐伟,等.氨磺必利与利培酮治疗首发精神分裂症疗效和安全性对照研究[J].中国神经精神疾病杂志,2012,38(4):249-252.
[8]徐瑞娟.氨磺必利治疗精神分裂症的疗效和安全性[J].中国卫生产业,2012,9(3):61-63.
[9]姜涛,迟勇,郑彀.氨磺必利治疗精神分裂症的疗效和安全性[J].神经疾病与精神卫生,2011,11(4):375-376.
[10]Harrigan EP,Miceli JJ,Anziano R,et a1.Arandomized evaluation of the effects Of six antipsyehotic agents on QTc in the absence and presence of metabolic inhibition[J].J Clin Psychopharmacol,2004,24(1):62-69.
[11]谢少烽.氨磺必利对精神分裂症患者的疗效研究[J].精神医学杂志,2012,25(4):300-302.
[12]Stefan L,Caroline C,Dieter A.Second-generation versus firstgeneration antipsyehotic drugs for schizophrenia:a meta analysis[J].Lancet,2009,373:31-41.
[13]Muller HJ,Regenbogen B,H rtter S,et a1.Therapeutic drug monitoring for optimizing amisulpride therapy in patients with schizophrenia[J].J Psychiatr Res,2007,41(8):673-679.
[14]张凤琴,彭健,张克坚.对新药研发中致QTc间期延长药物的思考[J].中国新药杂志,2004,13(3):193-197.
[15]Stefan L,Caroline C,Dieter A.Second-generation versus firstgeneration antipsyehotic drugs for schizophrenia:a meta analysis[J].Lancet,2009,373:31-41.
[16]陈颖,吴晓燕,瞿发林.非典型抗精神病药物的代谢及其引起的药物相互作用[J].实用药物与临床,2010,13(5):374-376.
[2]陈妍,陈美娟.氨磺必利在精神分裂症中的研究进展[J].神经疾病与精神卫生,2011,11(1):83-85.
[3]范肖东.精神与行为障碍分类临床描述与诊断要点(ICD-10)[M].北京:人民卫生出版社,1993:70-106.
[4]Stephen B,Steven R,Warren S,et a1.Designing clinical research:an epidemionlogic approach[M].New York:Lippincott Williams&wilkins,2001:235-237.
[5]Komossa K,Rummel-Kluge C,Schwarz S,et a1.Amisulpride versus other atypical antipsychotics for schizophrenia[J].Cochrane Database Syst Rev,2010,(1):CD006624.
[6]黄素培,张瑞岭,王来海,等.氨磺必利的药理学进展与临床应用评价[J].中国医院用药评价与分析,2011,11(8):679-683.
[7]刘林晶,刘家洪,唐伟,等.氨磺必利与利培酮治疗首发精神分裂症疗效和安全性对照研究[J].中国神经精神疾病杂志,2012,38(4):249-252.
[8]徐瑞娟.氨磺必利治疗精神分裂症的疗效和安全性[J].中国卫生产业,2012,9(3):61-63.
[9]姜涛,迟勇,郑彀.氨磺必利治疗精神分裂症的疗效和安全性[J].神经疾病与精神卫生,2011,11(4):375-376.
[10]Harrigan EP,Miceli JJ,Anziano R,et a1.Arandomized evaluation of the effects Of six antipsyehotic agents on QTc in the absence and presence of metabolic inhibition[J].J Clin Psychopharmacol,2004,24(1):62-69.
[11]谢少烽.氨磺必利对精神分裂症患者的疗效研究[J].精神医学杂志,2012,25(4):300-302.
[12]Stefan L,Caroline C,Dieter A.Second-generation versus firstgeneration antipsyehotic drugs for schizophrenia:a meta analysis[J].Lancet,2009,373:31-41.
[13]Muller HJ,Regenbogen B,H rtter S,et a1.Therapeutic drug monitoring for optimizing amisulpride therapy in patients with schizophrenia[J].J Psychiatr Res,2007,41(8):673-679.
[14]张凤琴,彭健,张克坚.对新药研发中致QTc间期延长药物的思考[J].中国新药杂志,2004,13(3):193-197.
[15]Stefan L,Caroline C,Dieter A.Second-generation versus firstgeneration antipsyehotic drugs for schizophrenia:a meta analysis[J].Lancet,2009,373:31-41.
[16]陈颖,吴晓燕,瞿发林.非典型抗精神病药物的代谢及其引起的药物相互作用[J].实用药物与临床,2010,13(5):374-376.