氨磺必利与氯丙嗪对精神病患者心电图影响的对照研究

Control study of the effect of amisulpride and chlorpromazine on electrocardiogram of psychiatric patients

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.