Idaho Drug Information Service, College of Pharmacy, Idaho State University, 921 S. 8th Ave., Stop 8092, Pocatello, ID 83209, USA.
Ann Pharmacother. 2010 Mar;44(3):572-6. doi: 10.1345/aph.1M519. Epub 2010 Feb 2.
To evaluate the efficacy and safety of proton pump inhibitors (PPIs) in the treatment of gastroesophageal reflux disease (GERD) in infants <1 year of age.
A literature search was conducted through PubMed (up to December 2009), International Pharmaceutical Abstracts (1970-December 2009), and The Cochrane Library (up to December 2009) using combinations of the following key search terms: proton pump inhibitor, GERD, infant, children, pediatric, omeprazole, rabeprazole, lansoprazole, esomeprazole, and pantoprazole. Reference citations from identified articles were also reviewed.
All double-blind, placebo-controlled trials published in English that evaluated the safety and efficacy of PPIs in infants with GERD were included in this review. Trials involving children older than 12 months were not included.
GERD is a source of pain and discomfort in adults; yet, in infants, symptoms that are thought to be indicative of painful stimuli have no clear cause-and-effect relationship with infant GERD. PPIs are beneficial in relieving symptoms of GERD in the adult population, but their usefulness in decreasing GERD-associated behaviors in infants is still questionable, despite a large increase in PPI prescribing for children <1 year of age. In all studies reviewed, infants treated with PPIs did not experience a significant decrease in behaviors perceived to be caused by GERD. The largest placebo-controlled trial to date found that rates of adverse events were increased in the PPI group compared with the placebo group, whereas the other trials reviewed reported no difference in adverse effects with the use of PPIs.
Clinical trials reveal that PPI therapy is not an effective treatment for common infant GERD-associated symptoms. Evidence supporting safety of PPI use in infants is conflicting, and more large-scale, randomized, placebo-controlled trials are necessary to better establish the role of PPIs in infant GERD.
评估质子泵抑制剂（PPIs）在治疗 1 岁以下婴儿胃食管反流病（GERD）中的疗效和安全性。
通过 PubMed（截至 2009 年 12 月）、国际药学文摘（1970 年-2009 年 12 月）和 Cochrane 图书馆（截至 2009 年 12 月）进行文献检索，使用以下关键词组合：质子泵抑制剂、GERD、婴儿、儿童、儿科、奥美拉唑、雷贝拉唑、兰索拉唑、埃索美拉唑和泮托拉唑。还审查了已确定文章的参考文献。
所有发表的英文双盲、安慰剂对照试验，评估了 PPIs 在 GERD 婴儿中的安全性和疗效均纳入本综述。未纳入涉及 12 个月以上儿童的试验。
GERD 是成人疼痛和不适的原因；然而，在婴儿中，被认为是疼痛刺激的症状与婴儿 GERD 没有明确的因果关系。PPIs 可有效缓解成人 GERD 症状，但在降低婴儿 GERD 相关行为方面的作用仍存在争议，尽管 1 岁以下儿童开具 PPI 的数量大幅增加。在所有综述的研究中，用 PPI 治疗的婴儿没有经历被认为是 GERD 引起的行为的显著减少。迄今为止最大的安慰剂对照试验发现，与安慰剂组相比，PPIs 组的不良事件发生率增加，而其他综述的试验报告使用 PPIs 无不良反应差异。
临床试验表明，PPI 治疗不是治疗常见婴儿 GERD 相关症状的有效方法。支持 PPI 在婴儿中使用安全性的证据相互矛盾，需要更大规模、随机、安慰剂对照试验来更好地确定 PPI 在婴儿 GERD 中的作用。
