van der Stuijt Willeke, Gal Pim, Kemme Michiel J B, Burggraaf Jacobus
Leiden University Medical Centre, Leiden, The Netherlands.
Centre for Human Drug Research, Leiden, The Netherlands.
Ann Noninvasive Electrocardiol. 2019 Sep;24(5):e12643. doi: 10.1111/anec.12643. Epub 2019 Apr 1.
During early drug development trials, electrocardiograms (ECGs) in healthy volunteers who are in a fasting state are evaluated to screen for possible adverse cardiac effects. However, the effect of the duration of fasting on electrocardiographic parameters is largely unknown. We compared the effects of fasting on standard 12-lead electrocardiographic recordings.
Electrocardiograms were available for 432 healthy subjects (mean age 28.5 ± 12.5; 88.9% male) who participated in early drug development studies after 4- and 10-hr fasting. All ECGs were automatically analyzed for conduction intervals and wave amplitudes with the Marquette 12SL algorithm and compared among fasting duration. Mixed model analyses were used to identify confounding variables.
After 10 hr of fasting, compared to after 4 hr of fasting, mean P-wave duration and amplitude were reduced by 1.95 ± 1.48 ms and 2.18 ± 2.75 μV, mean R wave and S wave amplitude were decreased by 25.83 ± 31.16 μV and 55.39 ± 78.72 μV, mean QRS duration was decreased by 1.84 ± 6.61 ms, and mean T-wave duration and amplitude were decreased by 2.06 ± 0.72 ms and 9.36 ± 17.21 μV (lead II). The mean PR interval was prolonged by 4.26 ± 17.67 ms, the ventricular rate was reduced by 3.64 ± 8.61 min, and QTcF was reduced by 3.87 ± 14.50 ms. These observations persisted after correction for demographics, electrolytes, blood pressure, heart rate variability, and diurnal variation.
The present analysis showed that 10-hr fasting compared to 4-hr fasting resulted in changes to the surface ECG, consisting of a reduced wave amplitude and duration and increased isoelectric interval duration.
在早期药物开发试验期间，会对处于禁食状态的健康志愿者的心电图（ECG）进行评估，以筛查可能的心脏不良影响。然而，禁食持续时间对心电图参数的影响在很大程度上尚不清楚。我们比较了禁食对标准12导联心电图记录的影响。
432名健康受试者（平均年龄28.5±12.5岁；88.9%为男性）参与了早期药物开发研究，在禁食4小时和10小时后均有心电图记录。所有心电图均使用马奎特12SL算法自动分析传导间期和波幅，并在不同禁食持续时间之间进行比较。采用混合模型分析来识别混杂变量。
禁食10小时后，与禁食4小时相比，平均P波持续时间和幅度分别降低了1.95±1.48毫秒和2.18±2.75微伏，平均R波和S波幅度分别降低了25.83±31.16微伏和55.39±78.72微伏，平均QRS持续时间降低了1.84±6.61毫秒，平均T波持续时间和幅度分别降低了2.06±0.72毫秒和9.36±17.21微伏（II导联）。平均PR间期延长了4.26±17.67毫秒，心室率降低了3.64±8.61次/分钟，QTcF降低了3.87±14.50毫秒。在对人口统计学、电解质、血压、心率变异性和昼夜变化进行校正后，这些观察结果仍然存在。
本分析表明，与禁食4小时相比，禁食10小时会导致体表心电图发生变化，包括波幅和持续时间降低以及等电位间期持续时间增加。
