Department of Pediatric Gastroenterology and Nutrition, Emma Children's Hospital/Academic Medical Center, Meibergdreef 9, C2-312, 1105 AZ Amsterdam, Netherlands.
Pediatrics. 2011 May;127(5):925-35. doi: 10.1542/peds.2010-2719. Epub 2011 Apr 4.
Use of proton-pump inhibitors (PPIs) for the treatment of gastroesophageal reflux disease (GERD) in children has increased enormously. However, effectiveness and safety of PPIs for pediatric GERD are under debate.
We performed a systematic review to determine effectiveness and safety of PPIs in children with GERD.
We searched PubMed, Embase, and the Cochrane Database of Systematic Reviews for randomized controlled trials and crossover studies investigating efficacy and safety of PPIs in children aged 0 to 18 years with GERD for reduction in GERD symptoms, gastric pH, histologic aberrations, and reported adverse events.
Twelve studies were included with data from children aged 0-17 years. For infants, PPIs were more effective in 1 study (compared with hydrolyzed formula), not effective in 2 studies, and equally effective in 2 studies (compared with placebo) for the reduction of GERD symptoms. For children and adolescents, PPIs were equally effective (compared with alginates, ranitidine, or a different PPI dosage). For gastric acidity, in infants and children PPIs were more effective (compared with placebo, alginates, or ranitidine) in 4 studies. For reducing histologic aberrations, PPIs showed no difference (compared with ranitidine or alginates) in 3 studies. Six studies reported no differences in treatment-related adverse events (compared with placebo or a different PPI dosage).
PPIs are not effective in reducing GERD symptoms in infants. Placebo-controlled trials in older children are lacking. Although PPIs seem to be well tolerated during short-term use, evidence supporting the safety of PPIs is lacking.
质子泵抑制剂 (PPI) 被广泛用于治疗儿童胃食管反流病 (GERD),然而,PPI 治疗小儿 GERD 的有效性和安全性仍存在争议。
我们进行了一项系统评价,以确定 PPI 在小儿 GERD 中的疗效和安全性。
我们检索了 PubMed、Embase 和 Cochrane 系统评价数据库,以确定治疗小儿 GERD 的 PPI 的随机对照试验和交叉研究,评估 PPI 在减少 GERD 症状、胃 pH 值、组织学异常和报告的不良事件方面的疗效和安全性。
共纳入 12 项研究,涉及 0-17 岁儿童的数据。对于婴儿,1 项研究表明 PPI 比水解配方更有效,2 项研究表明 PPI 无效,2 项研究表明 PPI 与安慰剂等效(用于减少 GERD 症状)。对于儿童和青少年,PPI 与藻酸盐、雷尼替丁或不同剂量的 PPI 等效。对于胃酸度,4 项研究表明 PPI 在婴儿和儿童中比安慰剂、藻酸盐或雷尼替丁更有效。3 项研究表明,在减少组织学异常方面,PPI 与雷尼替丁或藻酸盐无差异。6 项研究报告治疗相关不良事件无差异(与安慰剂或不同剂量的 PPI 相比)。
PPI 不能有效减轻婴儿的 GERD 症状。缺乏针对年龄较大儿童的安慰剂对照试验。尽管 PPI 在短期使用中似乎耐受良好,但缺乏支持 PPI 安全性的证据。