Caraballo Lucía, Molina Gabriel, Weitz Darío, Piskulic Laura, Avila Aylén, Marzi Marta
Departamento de Matemática y Estadística, Facultad de Ciencias Bioquímicas y Farmacéuticas. Universidad Nacional de Rosario. Argentina..
Farm Hosp. 2014 Sep 16;38(5):438-44. doi: 10.7399/fh.2014.38.5.7957.
To assess the association of the use of domperidone in infants with QTc interval prolongation and proarrhythmic events.
A systematic search of the scientific literature was conducted without any date or language restriction. The electronic database MEDLINE and the sources LILACS, ScIELO and Cochrane library were consulted.
From the twelve identified studies, eight were excluded because they did not meet the inclusion criteria. One case report and three pilot studies were selected. Rocha et al (2005) reported the case of an infant (age 3 months) with QTc interval = 463 ms after being treated during one month with 1.8 mg/kg/day of oral domperidone. Djeddi et al (2008) administered an average dose of 1.3 mg/kg/day to 31 neonates; QTc interval prolongation > 30 ms was observed in nine neonates. Hegar et al (2009) studied 10 infants (mean age 5.6 months) who received 0.8 mg/ kg/day of oral domperidone; QTc interval prolongation was not observed. Günlemez et al (2010) enrolled 40 premature infants who were administered 1 mg/kg/day of oral domperidone; the QTc interval increased to above 450 ms in two infants.
Although evidence that orally administrated domperidone in infants produces prolongation of QTc interval was found, further studies are needed in order to quantify the risk associated with the drug in that population. We suggest that heath professionals should conduct ECGs to infants treated with domperidone and inform the pharmacovigilance system the occurrence of any case of adverse event.
评估婴儿使用多潘立酮与QTc间期延长及促心律失常事件之间的关联。
对科学文献进行系统检索，无日期或语言限制。查阅了电子数据库MEDLINE以及LILACS、ScIELO和Cochrane图书馆等资源。
在确定的12项研究中，8项因不符合纳入标准而被排除。选取了1例病例报告和3项初步研究。罗查等人（2005年）报告了1例3个月大的婴儿，在接受1.8毫克/千克/天的口服多潘立酮治疗1个月后，QTc间期为463毫秒。杰迪等人（2008年）给31名新生儿平均服用剂量为1.3毫克/千克/天的多潘立酮；9名新生儿出现QTc间期延长>30毫秒。黑加尔等人（2009年）研究了10名接受0.8毫克/千克/天口服多潘立酮的婴儿（平均年龄5.6个月）；未观察到QTc间期延长。居内勒梅兹等人（2010年）纳入了40名接受1毫克/千克/天口服多潘立酮的早产儿；2名婴儿的QTc间期增至450毫秒以上。
虽然发现有证据表明婴儿口服多潘立酮会导致QTc间期延长，但仍需要进一步研究以量化该人群中与该药物相关的风险。我们建议医疗专业人员应对接受多潘立酮治疗的婴儿进行心电图检查，并将任何不良事件病例的发生情况告知药物警戒系统。
