Department of Pediatric Intensive Care Service, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
J Pediatr. 2013 Apr;162(4):776-782.e1. doi: 10.1016/j.jpeds.2012.10.010. Epub 2012 Nov 10.
To compare the effect of 2 doses of intravenous omeprazole on gastric pH, gastrointestinal bleeding, and adverse effects in critically ill children.
We undertook a prospective randomized clinical trial in critically ill children at risk of gastrointestinal bleeding. The effect of 2 intravenous omeprazole regimens (0.5 or 1 mg/kg every 12 hours) on the gastric pH and incidence of gastrointestinal hemorrhage was compared. The efficacy criteria were a gastric pH >4 and the absence of clinically significant gastrointestinal bleeding.
Forty patients, 20 in each treatment group, were studied. Overall, the gastric pH was greater than 4 for 57.8% of the time, with no difference between the doses (P = .66). The percentage of time with a gastric pH > 4 increased during the study (47.8% between 0 and 24 hours vs 76% between 24 and 48 hours, P = .001); the greater dose showed a greater increase in the percentage of time with a pH > 4: between hours 24 and 48 of the study, the gastric pH was greater than 4 for 84.5% of the time with the 1 mg/kg dose and for 65.5% of the time with the 0.5 mg/kg dose (P = .036). Plasma omeprazole levels were greater with 1 mg/kg dose, but no correlation was found between omeprazole plasma levels and gastric pH. No toxic adverse effects were detected, and there was no clinically significant bleeding.
Neither of the 2 omeprazole regimens achieved adequate alkalinization of the gastric pH during the first 24 hours. Between 24 and 48 hours, the 1 mg/kg dose maintained the gastric pH greater than 4 for a greater percentage of the time.
比较两种剂量静脉用奥美拉唑对危重症患儿胃 pH 值、胃肠道出血及不良反应的影响。
我们对有胃肠道出血风险的危重症患儿进行了一项前瞻性随机临床试验。比较了两种静脉用奥美拉唑方案（0.5 或 1 mg/kg，每 12 小时 1 次）对胃 pH 值和胃肠道出血发生率的影响。疗效标准为胃 pH 值>4 和无临床显著胃肠道出血。
40 例患儿（每组 20 例）入组研究。总体而言，胃 pH 值>4 的时间占 57.8%，两种剂量之间无差异（P=0.66）。研究期间胃 pH 值>4 的时间百分比增加（0 至 24 小时为 47.8%，24 至 48 小时为 76%，P=0.001）；较大剂量组胃 pH 值>4 的时间百分比增加更大：研究的第 24 至 48 小时，1 mg/kg 剂量组胃 pH 值>4 的时间占 84.5%，0.5 mg/kg 剂量组为 65.5%（P=0.036）。1 mg/kg 剂量组的奥美拉唑血药浓度较高，但奥美拉唑血药浓度与胃 pH 值之间无相关性。未发现毒副作用，也无临床显著出血。
两种奥美拉唑方案在最初 24 小时内均未使胃 pH 值充分碱化。在第 24 至 48 小时，1 mg/kg 剂量组使胃 pH 值>4 的时间百分比更大。
