摘要
目的:总结分析心电监测在Ⅰ期药物临床试验中的应用价值。方法:在五类十二种心血管药物Ⅰ期临床试验中,通过心电监测实时记录受试者12导联全信息心电信号,分析330例年轻健康男性心电监测资料。结果:330例健康男性受试者Ⅰ期试验观察均为窦性心律,3.6%有窦性静止、房室阻滞、逸搏,但缓慢型心律失常均发生在夜间;37.9%检出房性早搏;23.6%检出室性早搏。结论:正常年轻健康男性在Ⅰ期药物临床试验中经心电监测可检出有不同程度的心律失常。心电监测在Ⅰ期药物临床试验中具有重要应用价值。
Objective：To analyze and summarize the application value of ECG monitoring in phase 1 clinical trial of cardiovascular drugs. Methods： In the phase Ⅰ clinical trial of twelve cardiovascular drugs among five classes, ECG monitoring data of 330 healthy mate subjects were analyzed through real-time recording subject＇s twelve lead electro-cardio-signal. Result： All of the 330 subjects were sinus rhythm,but 3.6% with sinus arrest.ventricalar escape beat,or atrial-ventricular （A-V） block, and bradyarrhythmia were discovered only in night; 37,9% with atrial extrasystole, 23,6% with ventrieutar extrasystole. Conclusion： By ECG monitoring, varied arrhythmia can be detected in young healthy volunteers, So more attentions should be paid to ECG monitoring; especially when phase Ⅰ clinical trial of cardiovascular drugs are performed.
出处
《中国医药导刊》
2009年第10期1706-1707,共2页
Chinese Journal of Medicinal Guide
关键词
心电监测
1期药物临床试验
应用价值
ECG monitoring
phase Ⅰ clinical trial
the application value
