Orsi Marina, Donato Gabriela, Busoni Verónica, Naisberg Gabriela, Caruso Norberto
Sanatorio Mater Dei, Ciudad Autónoma de Buenos Aires, Argentina.
Acta Gastroenterol Latinoam. 2011 Jun;41(2):111-8.
BACKGROUND: Gastroesophageal reflux disease (GERD) has a prevalence of 10% to 20% in the pediatric population. The 24-hour pHmetry is still considered the "gold standard" for its correct diagnosis. Omeprazole is the elective drug for a proper treatment. However, there are no adequate pharmaceutical presentation forms for infants. OBJECTIVE: To assess the acid suppression capacity of a new pharmaceutical association of omeprazole with sodium bicarbonate and sodium alginate (OBA), powder for oral suspension, in small infants with GERD. The response was measured according to the gastric variations of pH after a 3-day treatment with OBA. PATIENTS AND METHOD: This is a pilot, prospective, open study in infants with no congenital nor associated anomalies under 12 months of age with GERD. Two double channel pHmetry with gastric sensor were performed on different days in the same patient. The first one to establish the diagnosis (day 0) and the second one (day 3) after receiving omeprazole (OBA) at 1.5 mg/kg/day in a twice/dose/day (BID). RESULTS: The comparison between the frst and the second gastric pHmetry showed a statistically significant reduction in gastric acidity. No adverse events were observed in infants and the suspension flavor was palatable. CONCLUSIONS: This new presentation of omeprazole (OBA) with sodium bicarbonate and sodium alginate powder for oral suspension is capable of a significant and intense acid suppression, necessary for treatment of infants with GERD. The taste of the solution was well accepted by all the babies, which is a very important finding for this age group.
背景:胃食管反流病(GERD)在儿科人群中的患病率为10%至20%。24小时pH监测仍被认为是其正确诊断的“金标准”。奥美拉唑是适当治疗的首选药物。然而,对于婴儿来说,没有足够合适的药物剂型。 目的:评估奥美拉唑与碳酸氢钠和海藻酸钠的新型药物组合(OBA)口服混悬剂粉末对患有GERD的小婴儿的抑酸能力。根据用OBA治疗3天后胃内pH值的变化来衡量反应。 患者和方法:这是一项针对12个月以下无先天性或相关异常的GERD婴儿的前瞻性开放性试验研究。在同一患者的不同日期进行两次带胃传感器的双通道pH监测。第一次用于确诊(第0天),第二次(第3天)是在以1.5mg/kg/天的剂量、每日两次(bid)接受奥美拉唑(OBA)治疗后进行。 结果:第一次和第二次胃pH监测的比较显示胃酸度有统计学意义的降低。在婴儿中未观察到不良事件,且混悬剂味道可口。 结论:这种含碳酸氢钠和海藻酸钠的奥美拉唑新型口服混悬剂粉末(OBA)能够显著且强效地抑制胃酸,这对于治疗GERD婴儿是必要的。该溶液的味道被所有婴儿欣然接受,这对于这个年龄组来说是一个非常重要的发现。
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