Moore David John, Tao Billy Siang-Kuo, Lines David Robin, Hirte Craig, Heddle Margaret Lila, Davidson Geoffrey Paul
Centre for Paediatric and Adolesent Gastroenterology, Women's and Children's Hospital, North Adelaide, SA 5006, Australia.
J Pediatr. 2003 Aug;143(2):219-23. doi: 10.1067/S0022-3476(03)00207-5.
To assess the efficacy of omeprazole in treating irritable infants with gastroesophageal reflux and/or esophagitis.
Irritable infants (n=30) 3 to 12 months of age met the entry criteria of esophageal acid exposure >5% (n=22) and/or abnormal esophageal histology (n=15). They completed a 4-week, randomized, double-blind, placebo-controlled crossover trial of omeprazole. Cry/fuss diary (minutes/24 hours) and a visual analogue scale of infant irritability as judged by parental impression were obtained at baseline and the end of each 2-week treatment period.
The reflux index fell significantly during omeprazole treatment compared with placebo (-8.9%+/-5.6%, -1.9%+/-2.0%, P<.001). Cry/fuss time decreased from baseline (267+/-119), regardless of treatment sequence (period 1, 203+/-99, P<.04; period 2, 188+/-121, P<.008). Visual analogue score decreased from baseline to period 2 (6.8+/-1.6, 4.8+/-2.9, P=.008). There was no significant difference for both outcome measures while taking either omeprazole or placebo.
Compared with placebo, omeprazole significantly reduced esophageal acid exposure but not irritability. Irritability improved with time, regardless of treatment.
评估奥美拉唑治疗患有胃食管反流和/或食管炎的易激惹婴儿的疗效。
3至12个月大的易激惹婴儿（n = 30）符合食管酸暴露> 5%（n = 22）和/或食管组织学异常（n = 15）的纳入标准。他们完成了一项为期4周的奥美拉唑随机、双盲、安慰剂对照交叉试验。在基线以及每个2周治疗期结束时，获取哭闹/烦躁日记（分钟/24小时）以及由父母印象判断的婴儿易激惹视觉模拟量表。
与安慰剂相比，奥美拉唑治疗期间反流指数显著下降（-8.9%±5.6%，-1.9%±2.0%，P <.001）。哭闹/烦躁时间从基线水平下降（267±119），无论治疗顺序如何（第1期，203±99，P <.04；第2期，188±121，P <.008）。视觉模拟评分从基线到第2期下降（6.8±1.6，4.8±2.9，P =.008）。服用奥美拉唑或安慰剂时，两种结局指标均无显著差异。
与安慰剂相比，奥美拉唑显著降低了食管酸暴露，但未降低易激惹程度。无论治疗如何，易激惹程度随时间改善。
