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替戈拉赞与质子泵抑制剂治疗糜烂性食管炎的疗效和安全性比较:一项系统评价和荟萃分析

Comparative Efficacy and Safety of Tegoprazan Versus Proton Pump Inhibitors for Erosive Esophagitis: A Systematic Review and Meta-Analysis.

作者信息

Hussaini Helai, Kebede Tamiru M, Afework Tekleweyn S, Kumari Deepa, Fadeyi Olaniyi, Chaudhari Sandipkumar S, Habib Ihtisham, Hirani Shamsha

机构信息

Internal Medicine, West Anaheim Medical Center, Anaheim, USA.

General Medicine, Jimma University Public Science and Medical School, Jimma, ETH.

出版信息

Cureus. 2025 May 1;17(5):e83302. doi: 10.7759/cureus.83302. eCollection 2025 May.

Abstract

This systematic review and meta-analysis evaluated the efficacy and safety of tegoprazan compared to proton pump inhibitors (PPIs) in the treatment of erosive esophagitis (EE). A comprehensive literature search was conducted across multiple electronic databases from inception to 25 March 2025. Randomized controlled trials comparing tegoprazan with PPIs in patients with endoscopically confirmed EE were included. Primary outcomes were healing rates and safety profiles. Four randomized controlled trials comprising 963 patients were included. Meta-analysis revealed comparable healing rates between tegoprazan and PPIs (RR: 1.03, 95% CI: 0.97-1.10), with no significant differences observed at both four weeks (RR: 1.05, 95% CI: 0.96-1.16) and eight weeks (RR: 1.01, 95% CI: 0.96-1.06). Safety analyses demonstrated similar profiles between treatments, with no significant differences in treatment-emergent adverse events (RR: 0.93, 95% CI: 0.73-1.35), drug-related adverse events (RR: 0.93, 95% CI: 0.51-1.69), or serious adverse events (RR: 1.07, 95% CI: 0.12-9.29). Symptom relief was comparable between groups across all studies, with tegoprazan showing consistent efficacy, regardless of CYP2C19 genotype. Most patients had mild to moderate EE (LA grades A and B), limiting conclusions about efficacy in severe cases. This first meta-analysis directly comparing tegoprazan with PPIs suggests that tegoprazan is an effective and safe alternative to PPIs for EE treatment. Its efficacy independent of CYP2C19 polymorphism represents a potential advantage. However, limitations include the small number of studies, predominantly Asian populations, and relatively short follow-up periods. Further research is needed to assess long-term outcomes and efficacy in diverse populations.

摘要

本系统评价和荟萃分析评估了替戈拉赞与质子泵抑制剂(PPI)相比在治疗糜烂性食管炎(EE)中的疗效和安全性。从数据库建立至2025年3月25日,对多个电子数据库进行了全面的文献检索。纳入了在内镜检查确诊为EE的患者中比较替戈拉赞与PPI的随机对照试验。主要结局为愈合率和安全性。纳入了四项包含963例患者的随机对照试验。荟萃分析显示,替戈拉赞与PPI的愈合率相当(RR:1.03,95%CI:0.97-1.10),在四周(RR:1.05,95%CI:0.96-1.16)和八周(RR:1.01,95%CI:0.96-1.06)时均未观察到显著差异。安全性分析表明,各治疗组之间的情况相似,治疗中出现的不良事件(RR:0.93,95%CI:0.73-1.35)、药物相关不良事件(RR:0.93,95%CI:0.51-1.69)或严重不良事件(RR:1.07,95%CI:0.12-9.29)均无显著差异。在所有研究中,各治疗组之间的症状缓解情况相当,替戈拉赞显示出一致的疗效,无论CYP2C19基因型如何。大多数患者为轻度至中度EE(洛杉矶分级A和B级),限制了对严重病例疗效的结论。这项首次直接比较替戈拉赞与PPI的荟萃分析表明,替戈拉赞是治疗EE的一种有效且安全的PPI替代药物。其疗效独立于CYP2C19多态性是一个潜在优势。然而,局限性包括研究数量少、主要为亚洲人群以及随访期相对较短。需要进一步研究以评估不同人群的长期结局和疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/be1d/12126153/0c7bea4ca609/cureus-0017-00000083302-i01.jpg

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