Pediatric Gastroenterology, Hospital Pequeno Príncipe - Pontifical University of Paraná (PUCPR), Curitiba, Brazil.
Acta Paediatr. 2012 May;101(5):494-6. doi: 10.1111/j.1651-2227.2012.02593.x. Epub 2012 Jan 27.
To prospectively evaluate the effects of oral domperidone on the QTc interval in infants.
Infants (0-1 year) with a diagnosis of gastro-oesophageal reflux (GOR) disease were included. A 12-lead electrocardiography (ECG) was performed in all infants at baseline and 1 h after the intake of domperidone after 7-14 days; the corrected QTc interval was calculated by one investigator (MV) according to Bazett's formula.
Forty-five infants were enrolled in this study. The mean gestational age was of 38.6 weeks (35.5-42.0), and the mean age at the start of domperidone was 75.3 days (19-218 days). No statistically significant difference in corrected QTc was observed between baseline and the second ECG (0.389 ± 0.02 vs. 0.397 ± 0.31; p 0.130)). A trend was observed regarding gender: Although there was no difference in QTc change in girls (p 0.622), there was a strong trend in boys (p 0.051). Two infants (both boys) had a clinically significant QTc prolongation (> 460 msec) without symptoms. The Spearman correlation test showed no relation between the QTc change and age (r: -0.05822; p 0.7284). There was no relation between domperidone dosage and QTc change.
Overall, the group-analysis showed no statistical significant difference in QTc duration induced by domperidone. However, 2/45 (4.4%) infants had a prolonged QTc interval (> 460 msec) induced by domperidone. As a consequence, QTc measurement should be recommended in routine in infants when domperidone is started.
前瞻性评估口服多潘立酮对婴儿 QTc 间期的影响。
纳入患有胃食管反流病（GOR）的婴儿（0-1 岁）。所有婴儿在服用多潘立酮后 7-14 天内均进行 12 导联心电图（ECG）检查，在基线和摄入多潘立酮后 1 小时，由一名研究人员（MV）根据 Bazett 公式计算校正 QTc 间期。
本研究共纳入 45 例婴儿。平均胎龄为 38.6 周（35.5-42.0），开始使用多潘立酮时的平均年龄为 75.3 天（19-218 天）。校正 QTc 在基线和第二次心电图检查之间无统计学差异（0.389±0.02 与 0.397±0.31；p＞0.130））。关于性别存在趋势：虽然女孩的 QTc 变化无差异（p＞0.622），但男孩存在强烈趋势（p=0.051）。有 2 例（均为男孩）婴儿出现无症状的临床显著 QTc 延长（＞460msec）。Spearman 相关检验显示 QTc 变化与年龄之间无关系（r：-0.05822；p＞0.7284）。多潘立酮剂量与 QTc 变化之间无关系。
总体而言，组分析显示多潘立酮引起的 QTc 持续时间无统计学显著差异。然而，有 2/45（4.4%）例婴儿在服用多潘立酮后出现 QTc 间期延长（＞460msec）。因此，建议在开始使用多潘立酮时常规测量 QTc。
