静脉注射昂丹司琼对胃肠炎儿童 QTc 间期的影响。

Effect of intravenous ondansetron on QTc interval in children with gastroenteritis.

机构信息

Sidra Medical and Research Center, Department of Emergency Medicine, PO Box 26999, Doha, Qatar.

Sidra Medical and Research Center, Department of Emergency Medicine, PO Box 26999, Doha, Qatar; Hamad General Hospital, Department of Pediatrics, PO Box 3050, Doha, Qatar.

出版信息

Am J Emerg Med. 2018 May;36(5):754-757. doi: 10.1016/j.ajem.2017.10.004. Epub 2017 Oct 4.

DOI:10.1016/j.ajem.2017.10.004

PMID:29029798

Abstract

BACKGROUND

The potential for ondansetron to cause QT prolongation and fatal dysrhythmia is well-reported, including a 2011 FDA report on the topic. Few clinical trials evaluating this phenomenon in the ED setting exist, and only one is pediatric.

OBJECTIVE

We have sought to determine the effect of a standardized dose of intravenous ondansetron on the QTc duration of children under 14years of age treated for gastroenteritis-associated vomiting in a pediatric ED. This study is modeled closely after an FDA "thorough QT study".

METHODS

EGCs were obtained before and 15, 30, 45, and 60min after a 0.15mg/kg IV dose of ondansetron given for gastroenteritis-associated vomiting. QT intervals were measured manually with digital calipers, and the QTc interval calculated both by Bazett's (QTcB) and Fridericia's (QTcF) correction. A paired t-test comparing QTc was conducted, and frequency of categorical outcomes of prolongation>30msec, >60 msec, and absolute prolongation >450 msec, >480 msec, and >500msec were evaluated.

RESULTS

In a 4-month period, 134 patients were included in the study, 46% were male. The average QTc prior to ondansetron administration was: QTcB 415 msec (95% CI 343-565) and QTcF 373 (95% CI 304-499). The mean difference in QTc after ondansetron was 0.4msec for QTcB (95% CI -35-45msec) and 0.1msec for QTcF (95% CI -40-18msec).

CONCLUSION

In these children, 0.15mg/kg of intravenous ondansetron did not cause prolongation of QTcB or QTcF measured 15min after administration, nor at later times.

摘要

背景

昂丹司琼有潜在引发 QT 间期延长和致命性心律失常的风险，这一点已有大量报道，包括 2011 年 FDA 对此发布的专题报告。目前仅有少数临床试验评估了急诊环境下的这一现象，且仅有一项为儿科研究。

目的

我们旨在确定在儿科急诊治疗胃肠炎相关性呕吐时，给予标准化剂量的静脉内昂丹司琼对 14 岁以下儿童的 QTc 持续时间的影响。本研究紧密模仿了 FDA 的“全面 QT 研究”。

方法

在给予 0.15mg/kg 的静脉内昂丹司琼治疗胃肠炎相关性呕吐后 15、30、45 和 60 分钟时，分别获取急诊就诊的胃肠炎相关性呕吐患儿的 EGC。使用数字卡尺手动测量 QT 间期，并分别使用 Bazett（QTcB）和 Fridericia（QTcF）校正法计算 QTc 间期。采用配对 t 检验比较 QTc，评估 QTc 延长>30msec、>60 msec 和绝对延长>450 msec、>480 msec 和>500msec 的分类结果的频率。

结果

在 4 个月的时间内，共有 134 名患者入组本研究，其中 46%为男性。昂丹司琼给药前平均 QTcB 为 415msec（95%CI 343-565），平均 QTcF 为 373（95%CI 304-499）。昂丹司琼给药后 QTc 的平均差值为 QTcB 为 0.4msec（95%CI -35-45msec），QTcF 为 0.1msec（95%CI -40-18msec）。