24小时动态心电图记录在健康志愿者中新化学实体评估中的应用。

Use of 24 h ambulatory ECG recordings in the assessment of new chemical entities in healthy volunteers.

Stinson J C, Pears J S, Williams A J, Campbell R W

Clinical Pharmacology Unit, Zeneca Pharmaceuticals, Alderley Park, Macclesfield, UK.

Br J Clin Pharmacol. 1995 Jun;39(6):651-6. doi: 10.1111/j.1365-2125.1995.tb05724.x.

Ambulatory (24 h) cardiac monitoring (ACM) is frequently used to screen healthy volunteers before inclusion in trials of new chemical entities in man. We analysed 156 consecutive ACM recordings in 'healthy' volunteers (on no medication). 2. Only 20 (13%) of the recordings showed normal sinus rhythm throughout. 3. Supraventricular ectopics were the commonest abnormality (83%). Ventricular ectopics occurred in 11%; ventricular tachycardia (unsustained) in 2% and sinus pauses in 6.5%. One volunteer was found to be in atrial fibrillation throughout. 4. The data indicate that when ACM recordings are performed in the assessment of the effects of experimental drugs, guidelines are needed to assess 'normality' to suggest when cardiological investigation is needed and to assign causality of the arrhythmia to the new chemical entity. 5. Proposed guidelines are presented.

动态（24小时）心脏监测（ACM）常用于在将健康志愿者纳入人体新化学实体试验之前进行筛查。我们分析了156份连续的“健康”志愿者（未服用任何药物）的ACM记录。2. 仅20份（13%）记录全程显示正常窦性心律。3. 室上性异位搏动是最常见的异常情况（83%）。室性异位搏动发生率为11%；室性心动过速（非持续性）发生率为2%，窦性停搏发生率为6.5%。发现一名志愿者全程处于心房颤动状态。4. 数据表明，在评估实验药物效果时进行ACM记录时，需要有指南来评估“正常情况”，以建议何时需要进行心脏检查，并将心律失常的因果关系归因于新化学实体。5. 本文提出了建议指南。

Use of 24 h ambulatory ECG recordings in the assessment of new chemical entities in healthy volunteers.