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美国食品药品监督管理局(FDA)批准的质子泵抑制剂治疗糜烂性食管炎的比较疗效与可接受性:一项遵循系统评价与Meta分析的首选报告项目(PRISMA)规范的网状Meta分析。

Comparative effectiveness and acceptability of the FDA-licensed proton pump inhibitors for erosive esophagitis: A PRISMA-compliant network meta-analysis.

作者信息

Li Mei-Juan, Li Qing, Sun Min, Liu Li-Qin

机构信息

School of Pharmacy, Shanxi Medical University Department of Pharmacy, The First Hospital of Shanxi Medical University, Taiyuan Department of Oncology, Zhongnan Hospital of Wuhan University, Hubei Key Laboratory of Tumor Biological Behaviors & Hubei Cancer Clinical Study Center, Wuhan Department of General Surgery, Taihe Hospital, Hubei University of Medicine, Shiyan, P.R. China.

出版信息

Medicine (Baltimore). 2017 Sep;96(39):e8120. doi: 10.1097/MD.0000000000008120.

Abstract

BACKGROUND

This study compared the effectiveness and acceptability of all Food and Drug Administration (FDA)-recommended dose proton pump inhibitors (PPIs) in erosive esophagitis (EE): Dexlansoprazole 60 mg, Esomeprazole 40 mg, Esomeprazole 20 mg, Pantoprazole 40 mg, Lansoprazole 30 mg, Rabeprazole 20 mg, Omeprazole 20 mg.

METHODS

A systematic literature search was performed using PubMed, Embase, and Cochrane Library. Totally, 25 randomized controlled trials (RCTs) met study selection criteria and were incorporated in this network meta-analysis (NMA) study.

RESULTS

For the NMA, eligible RCTs of adults with EE verified by endoscopic examination were randomly assigned to the licensed PPIs at least 4 weeks of continuous therapy. The primary efficacy outcome was the endoscopic healing rates at 4 and 8 weeks. Heartburn relief rates were a secondary efficacy outcome. The rates of withdrawal were analyzed as a safety outcome. In comparison to the common comparator omeprazole 20 mg, esomeprazole 40 mg provided significantly healing rates at 4 weeks [odds ratio (OR), 1.46 (95% confidence interval, 95% CI, 1.24-1.71)] and 8 weeks [1.58 (1.29-1.92)], and improved the heartburn relief rates [1.29 (1.07-1.56)]. In comparison to lansoprazole 30 mg, esomeprazole 40 mg provided significantly healing rates at 4 weeks [1.30 (1.10-1.53)] and 8 weeks [1.37 (1.13-1.67)], and improved the heartburn relief rates [1.29 (1.03-1.62)]. In terms of acceptability, only dexlansoprazole 60 mg had significantly more all-cause discontinuation than omeprazole 20 mg [1.54 (1.03-2.29)], pantoprazole 40 mg [1.68 (1.08-2.63)], and lansoprazole 30 mg [1.38 (1.02-1.88)].

CONCLUSION

The standard-dose esomeprazole 40 mg had more superiority in mucosal erosion healing and heartburn relief. Esomeprazole 40 mg, pantoprazole 40 mg, esomeprazole 20 mg, and lansoprazole 30 mg showed more benefits in effectiveness and acceptability than other interventions.

摘要

背景

本研究比较了美国食品药品监督管理局(FDA)推荐的所有剂量的质子泵抑制剂(PPI)治疗糜烂性食管炎(EE)的有效性和可接受性:右兰索拉唑60毫克、埃索美拉唑40毫克、埃索美拉唑20毫克、泮托拉唑40毫克、兰索拉唑30毫克、雷贝拉唑20毫克、奥美拉唑20毫克。

方法

使用PubMed、Embase和Cochrane图书馆进行系统文献检索。总共有25项随机对照试验(RCT)符合研究选择标准,并纳入了这项网络荟萃分析(NMA)研究。

结果

对于NMA,经内镜检查证实患有EE的成人合格RCT被随机分配接受至少4周持续治疗的已获许可的PPI。主要疗效指标是4周和8周时的内镜愈合率。烧心缓解率是次要疗效指标。将停药率作为安全性指标进行分析。与常用对照奥美拉唑20毫克相比,埃索美拉唑40毫克在4周时的愈合率显著更高[比值比(OR),1.46(95%置信区间,95%CI,1.24 - 1.71)]和8周时[1.58(1.29 - 1.92)],并提高了烧心缓解率[1.29(1.07 - 1.56)]。与兰索拉唑30毫克相比,埃索美拉唑40毫克在4周时的愈合率显著更高[1.30(1.10 - 1.53)]和8周时[1.37(1.13 - 1.67)],并提高了烧心缓解率[1.29(1.03 - 1.62)]。在可接受性方面,只有右兰索拉唑60毫克的全因停药率显著高于奥美拉唑20毫克[1.54(1.03 - 2.29)]、泮托拉唑40毫克[1.68(1.08 - 2.63)]和兰索拉唑30毫克[1.38(1.02 - 1.88)]。

结论

标准剂量的埃索美拉唑40毫克在黏膜糜烂愈合和烧心缓解方面具有更大优势。埃索美拉唑40毫克、泮托拉唑40毫克、埃索美拉唑20毫克和兰索拉唑30毫克在有效性和可接受性方面比其他干预措施显示出更多益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f4dd/5626283/58f00da0fbb5/medi-96-e8120-g001.jpg

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