School of Medicine, Department of Pediatrics, Division of Neonatology, Ankara University, Ankara, Turkey.
J Clin Pharmacol. 2010 Nov;50(11):1267-72. doi: 10.1177/0091270009338483. Epub 2010 May 20.
The objective of this study was to evaluate the effect of the antireflux barrier formed by Na alginate on pH-metry-defined acid reflux events in preterms. Four times/day, 1 mL/kg of Na alginate was administered as an intervention to the preterm infants whose gastroesophageal reflux disease was confirmed by 24-hour pH monitoring, and the measurement was repeated after 48 hours. The major outcomes were improvement in the number of reflux events per 24 hours, the duration of the longest episode, the number of episodes >5 minutes per 24 hours, and reflux index on pH-metry. Thirty-four (83%) of 41 preterm infants who completed the study had pathologic measurement on 24-hour pH monitoring; 27 (83%) of the patients responded to treatment, whereas 7 patients (17%) did not. Na alginate treatment significantly improved the number of episodes with pH <4 per 24 hours, the reflux index, the number of episodes >5 minutes with pH <4, and the duration of longest episode with pH <4. Patients showed significant improvement in 2 evaluated clinical symptoms, which were vomiting and weight gain after the treatment. No side effect except thickening of stool in 3 patients was observed. Na alginate treatment for gastroesophageal reflux disease in preterm infants seems to be safe and effective.
本研究旨在评估海藻酸钠形成的抗反流屏障对早产儿 pH 监测定义的酸反流事件的影响。对于经 24 小时 pH 监测证实患有胃食管反流病的早产儿，每天 4 次给予 1 mL/kg 的海藻酸钠作为干预措施，48 小时后重复测量。主要结局为 24 小时反流事件次数、最长反流时间、24 小时内 >5 分钟反流事件次数和 pH 监测反流指数的改善。34 例（83%）完成研究的 41 例早产儿在 24 小时 pH 监测中有病理测量值；27 例（83%）患者对治疗有反应，而 7 例（17%）患者没有。海藻酸钠治疗可显著改善 24 小时内 pH 值<4 的反流事件次数、反流指数、pH 值<4 的>5 分钟反流事件次数和 pH 值<4 的最长反流时间。治疗后，患者在 2 项评估的临床症状（呕吐和体重增加）上均有显著改善。除 3 例患者出现粪便变稠外，未观察到其他副作用。海藻酸钠治疗早产儿胃食管反流病似乎是安全有效的。
