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质子泵抑制剂预防药物性消化道损伤的临床指南/共识、系统评
价/Meta分析再评价 Δ
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魏 婷 ,都赛飞 ,刘 斌 ,张 俐 ,杨 宁 ,尉耘翠 ,王晓玲(1.哈尔滨市儿童医院药剂科,哈尔滨
150010;2.首都医科大学附属北京儿童医院药学部,北京 100045)
中图分类号 R975 文献标志码 A 文章编号 1001-0408(2021)17-2122-07
DOI 10.6039/j.issn.1001-0408.2021.17.13
摘 要 目的:对质子泵抑制剂(PPIs)预防药物性消化道损伤的临床指南/共识、系统评价/Meta分析进行再评价,为该类药物的临
床应用提供循证参考。方法:系统梳理国内外相关临床指南/共识、系统评价/Meta分析文献,从有效性、安全性、经济性等维度开
展再评价,分析PPIs预防成人及儿童药物性消化道损伤的临床应用现状。结果:经检索及筛选,共得到国内外PPIs预防药物相关
性消化道损伤的临床指南/共识14篇、系统评价/Meta分析10篇。在有效性方面,PPIs可以预防各种药物相关性的胃黏膜损伤、消
化道出血等消化道损伤,但该类药物在我国还未获得儿童适应证,其在儿童消化道疾病治疗中的广泛应用目前仍属于超说明书用
药。在安全性方面,PPIs常见的不良反应有头痛、胃肠道症状等,长期应用时可能存在引发肾脏疾病、骨折等风险。在经济性方
面,对于存在消化道和心血管疾病风险的部分患者,非甾体抗炎药(NSAIDs)联合PPIs的成本-效益较高;每日服用20 mg与40 mg
的埃索美拉唑预防NSAIDs所致溃疡复发的疗效相当,增加剂量并不能提高预防效果。结论:PPIs对药物性消化道损伤的预防作
用在有效性方面有循证证据支持,在成人中的安全性良好,具有一定的经济效益;但其在我国用于儿童属于超说明书用药,安全性
和经济性仍需部分参考成人研究结果。未来仍需开展多项基于中国儿童的多中心、前瞻性临床研究,为PPIs用于儿童药物性消化
道损伤的防治提供更多证据支持。
关键词 质子泵抑制剂;预防;药物性消化道损伤;成人;儿童;指南;共识;系统评价;Meta分析;再评价
Guidelines/Consensus and Systematic Review/Meta-analysis Reevaluation of Proton Pump Inhibitors in the
Prevention of Drug-induced Gastrointestinal Injury
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WEI Ting ,DU Saifei ,LIU Bin ,ZHANG Li ,YANG Ning ,YU Yuncui ,WANG Xiaoling (1. Dept. of
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Pharmacy,Harbin Children’s Hospital,Harbin 150010,China;2. Dept. of Pharmacy,Beijing Children’s
Hospital of Capital Medical University,Beijing 100045,China)
ABSTRACT OBJECTIVE:To reevaluate the guidelines/consensus,systematic review/Meta-analysis of proton pump inhibitors
(PPIs) in the prevention of drug-induced gastrointestinal injury,and to provide evidence-based reference for its clinical use.
METHODS: The relevant guidelines/consensus and systematic review/Meta-analysis literatures at home and abroad were
systematically reviewed,and the reevaluation was carried out from the effectiveness,safety and economy dimensions to analyze the
current situation of clinical use of PPIs in the prevention of drug-induced gastrointestinal injury in adults and children. RESULTS:
A total of 14 clinical guidelines/consensus and 10 systematic review/Meta-analysis literatures of PPIs for the prevention of
drug-related gastrointestinal injury at home and abroad were sorted out and included. In terms of effectiveness,PPIs could prevent
various drug-related gastric mucosal damage,gastrointestinal bleeding and other damage to the digestive tract,but PPIs had not yet
obtained the indication for children in China;PPIs were widely used in the treatment of children’s digestive tract diseases,which
belonged to off-label medication. In terms of safety,the common adverse reactions of PPIs included headache,gastrointestinal
symptoms,etc. There may be risks of kidney disease and fracture during long-term application. In terms of economy,for some
patients with digestive tract and cardiovascular disease risk,the economic benefit of NSAIDs combined with PPIs were higher;
esomeprazole 20 mg and 40 mg daily were equally effective in preventing ulcer recurrence caused by NSAIDs,but increasing the
dose could not improve the preventive effect. CONCLUSIONS:The preventive effect of PPIs on drug-induced gastrointestinal
injury is supported by evidence-based evidence. It has good safety in adults and has certain economic benefits;but it belongs to
off-label drug use in children in China,and the safety and economy still need to refer to the results of adult studies. In the future,a
number of multicenter prospective clinical studies based on Chinese pediatric population are still needed to provide more support for
the prevention and treatment of drug-induced gastrointestinal
Δ 基金项目:黑龙江省卫生健康委科研课题(No.2020-041);国家
injury by PPIs in children.
科技重大专项课题(No.2018ZX09721-003)
*主管药师,硕士。研究方向:儿科临床药学。电话:0451- KEYWORDS Proton pump inhibitors; Prevention; Drug-
84880139。E-mail:151468933@qq.com induced gastrointestinal injury; Adult; Child; Guideline;
# 通信作者:主任药师。研究方向:儿科药事管理。电话:0451- Consensus;Systematic review;Meta-analysis;Reevaluation
84880139。E-mail:1368229172@qq.com
·2122 · China Pharmacy 2021 Vol. 32 No. 17 中国药房 2021年第32卷第17期