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  

Guidelines/Consensus and Systematic Review/Meta-analysis Reevaluation of Proton Pump Inhibitors in the Prevention of Drug-induced Gastrointestinal Injury

作　　者：魏婷 都赛飞 刘斌 张俐 杨宁 尉耘翠 王晓玲 WEI Ting;DU Saifei;LIU Bin;ZHANG Li;YANG Ning;YU Yuncui;WANG Xiaoling(Dept.of Pharmacy,Harbin Children's Hospital,Harbin 150010,China;Dept.of Pharmacy,Beijing Children's Hospital of Capital Medical University,Beijing 100045,China)

机构地区：[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

出　　处：《中国药房》2021年第17期2122-2128,共7页China Pharmacy

基　　金：黑龙江省卫生健康委科研课题(No.2020-041);国家科技重大专项课题(No.2018ZX09721-003)。

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20mg与40mg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。OBJECTIVE:To reevaluate the guidelines/cons ensus,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 re evaluation 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 stu

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 

分 类 号：R975[医药卫生—药品]