质子泵抑制剂在儿童应激性溃疡预防中的作用:一项随机对照试验。

IF 1.7 4区 医学 Q2 PEDIATRICS
Indian pediatrics Pub Date : 2025-06-01 Epub Date: 2025-04-11 DOI:10.1007/s13312-025-00035-3
Ananya Kavilapurapu, A V Lalitha, Santu Ghosh
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引用次数: 0

摘要

目的:评价静脉注射泮托拉唑预防患儿应激性溃疡出血的疗效。方法:随机对照试验纳入1个月至18岁需要重症监护的儿童。参与者被随机分配每天接受静脉注射泮托拉唑或安慰剂(生理盐水)。主要结局是胃肠道出血(临床显著或明显)的发生率。次要结局是消化道出血的中位发病时间、呼吸机相关性肺炎(VAP)的发生率、住院时间、器官功能障碍评分和全因死亡率。结果:A组(泮托拉唑)和B组(安慰剂)分别为151例和150例。两组间消化道出血发生率无显著差异(A组:21/151 vs B组:19/150)[RR (95% CI) 1.03 (0.18, 5.82), P = 0.985]。在临床显著的胃肠道出血中观察到类似的结果(1.3% vs 0.6%;Rr (95% ci) 0.54 (0.21, 1.28);P = 0.653和明显的胃肠道出血[12.6% vs 12%;Rr (95% ci) 0.98 (0.39, 2.23);P值= 0.313]。多因素分析显示,泮托拉唑组(n = 29)与安慰剂组(n = 25)相比,凝血功能障碍患儿胃肠道出血发生率降低[RR (95%CI) 0.52 (0.32, 0.87);p = 0.022]。结论:在危重儿童中,泮托拉唑预防并没有降低胃肠道出血的发生率,尽管在凝血功能障碍儿童中观察到胃肠道出血的显著降低。试验注册:印度临床试验注册中心,编号:CTRI/2021/08/035785,注册日期:2021年8月18日。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Role of Proton Pump Inhibitor as Stress Ulcer Prophylaxis in Sick Children: A Randomized Controlled Trial.

Objective: To evaluate the efficacy of intravenous pantoprazole as a stress ulcer prophylaxis in sick children to prevent gastrointestinal (GI) bleeding.

Methods: A randomized controlled trial included children aged one-month to 18 years requiring intensive care. Participants were randomly assigned to receive intravenous pantoprazole or a placebo (normal saline) daily. The primary outcome was the incidence of GI bleeding (clinically significant or overt). Secondary outcomes were the median time of onset of GI bleeding, incidence of ventilator-associated pneumonia (VAP), duration of hospitalization, organ dysfunction scores, and all-cause mortality.

Results: A total of 151 and 150 children were allocated to group A (pantoprazole) and group B (placebo), respectively. No significant difference was observed in the incidence of GI bleeding between the groups (group A: 21/151 vs group B: 19/150 [RR (95% CI) 1.03 (0.18, 5.82), P = 0.985]. Comparable results were observed for clinically significant GI bleeding (1.3% vs 0.6%; RR (95% CI) 0.54 (0.21, 1.28); P = 0.653 and overt GI bleeding [12.6% vs 12%; RR (95% CI) 0.98 (0.39, 2.23); P value = 0.313]. On multivariate analysis, there was a reduced incidence of GI bleeding in children with coagulopathy in pantoprazole group (n = 29) as compared to placebo (n = 25) [RR (95%CI) 0.52 (0.32, 0.87); P = 0.022].

Conclusion: Among critically ill children, pantoprazole prophylaxis did not reduce the incidence of gastrointestinal bleeding, although, a notable decrease in gastrointestinal bleeding was observed in children with coagulopathy.

Trials registry: Clinical Trials Registry of India, Ref no: CTRI/2021/08/035785, Date of registration:18th August 2021.

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来源期刊
Indian pediatrics
Indian pediatrics 医学-小儿科
CiteScore
3.30
自引率
8.70%
发文量
344
审稿时长
3-8 weeks
期刊介绍: The general objective of Indian Pediatrics is "To promote the science and practice of Pediatrics." An important guiding principle has been the simultaneous need to inform, educate and entertain the target audience. The specific key objectives are: -To publish original, relevant, well researched peer reviewed articles on issues related to child health. -To provide continuing education to support informed clinical decisions and research. -To foster responsible and balanced debate on controversial issues that affect child health, including non-clinical areas such as medical education, ethics, law, environment and economics. -To achieve the highest level of ethical medical journalism and to produce a publication that is timely, credible and enjoyable to read.
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