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Vonoprazan 治疗重度而非轻度糜烂性食管炎优于兰索拉唑:一项随机对照试验的系统评价和荟萃分析。

Vonoprazan is superior to lansoprazole for healing of severe but not mild erosive esophagitis: A systematic review with meta-analysis of randomized controlled trials.

机构信息

Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.

Nuffield Department of Population Health, University of Oxford, Oxford, UK.

出版信息

J Gastroenterol Hepatol. 2024 Jun;39(6):988-999. doi: 10.1111/jgh.16486. Epub 2024 Feb 14.

Abstract

BACKGROUND AND AIM

Healing rates of severe erosive esophagitis (EE; Los Angeles [LA] Grade C/D) in patients treated with a proton pump inhibitor (PPI) is suboptimal (~60-70%). Vonoprazan, a potassium-competitive acid blocker, is suggested to have better healing rates in patients with severe EE. This meta-analysis compares the efficacy and safety of vonoprazan 20 mg versus lansoprazole 30 mg daily in healing EE, specifically in those with LA Grade C/D.

METHODS

We searched MEDLINE, Embase, and CENTRAL on May 24, 2023. Studies that randomized EE patients to vonoprazan 20 mg daily or lansoprazole 30 mg daily and compared healing rates were included. The risk of bias was assessed using Cochrane's Risk of Bias 2 tool. The fixed-effect model was used to obtain the pooled efficacy and safety outcomes. Subgroup analysis was done to compare healing rates in mild (LA Grade A/B) versus severe EE and based on study location.

RESULTS

Four randomized controlled trials (RCTs) with low risks of bias comprising 2208 participants were included. Vonoprazan 20 mg was superior to lansoprazole 30 mg daily in healing severe EE at all weeks (Week 2 RR 1.294 [95% CI 1.169-1.433], Week 4 1.160 [1.059-1.270], and Week 8 1.175 [95% CI 1.107-1.247]), but was similar for mild EE at all weeks (P-interaction < 0.01). Vonoprazan 20 mg was more efficacious than lansoprazole 30 mg at Week 8 in Western versus Asian studies (P-interaction < 0.01). Any, serious, and drug-related treatment-emergent adverse events were comparable between groups.

CONCLUSION

Vonoprazan 20 mg is superior to lansoprazole 30 mg for healing severe EE but not mild EE. Vonoprazan 20 mg daily has a similar safety profile to lansoprazole 30 mg daily.

摘要

背景与目的

质子泵抑制剂(PPI)治疗的重度糜烂性食管炎(EE;洛杉矶[LA]分级 C/D)的愈合率不理想(约 60-70%)。钾竞争性酸阻滞剂 vonoprazan 被认为在重度 EE 患者中的愈合率更高。这项荟萃分析比较了 vonoprazan 20mg 与兰索拉唑 30mg 每日治疗 EE 的疗效和安全性,特别是在 LA 分级 C/D 的患者中。

方法

我们于 2023 年 5 月 24 日检索了 MEDLINE、Embase 和 CENTRAL。纳入将 EE 患者随机分配至每日 vonoprazan 20mg 或兰索拉唑 30mg 并比较愈合率的研究。使用 Cochrane's Risk of Bias 2 工具评估偏倚风险。使用固定效应模型获得汇总的疗效和安全性结局。进行亚组分析以比较轻度(LA 分级 A/B)与重度 EE 以及基于研究地点的愈合率。

结果

纳入了 4 项偏倚风险较低的随机对照试验(RCT),共 2208 名参与者。与兰索拉唑 30mg 每日治疗相比,vonoprazan 20mg 在所有周(第 2 周 RR 1.294[95%CI 1.169-1.433],第 4 周 1.160[1.059-1.270],第 8 周 1.175[95%CI 1.107-1.247])均能更有效地治疗重度 EE,但在所有周对轻度 EE 的疗效相似(P 交互<0.01)。在西方研究中,vonoprazan 20mg 在第 8 周的疗效优于兰索拉唑 30mg,而在亚洲研究中则相似(P 交互<0.01)。任何、严重和药物相关的治疗中出现的不良事件在两组之间相当。

结论

与兰索拉唑 30mg 相比,vonoprazan 20mg 更能有效治疗重度 EE,但对轻度 EE 无效。vonoprazan 20mg 每日的安全性与兰索拉唑 30mg 每日相似。

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