The efficacy and safety of budesonide combined with azathioprine versus predniso(lo)ne combined with azathioprine for autoimmune hepatitis: A systematic review and meta-analysis

IF 2.6 4区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY

Clinics and research in hepatology and gastroenterology Pub Date : 2025-11-01 Epub Date: 2025-10-09 DOI:10.1016/j.clinre.2025.102708

Ting Tong , Xu Hui , Ruizhi Shi , Junfeng Li , Li Xu , Liting Zhang , Kehu Yang

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引用次数: 0

Abstract

Background and Aim

The efficacy and safety of budesonide combined with azathioprine (AZA) compared to predniso(lo)ne combined with AZA in the treatment of autoimmune hepatitis (AIH) remain uncertain. This study aimed to compare the efficacy and safety of two combination regimens.

Methods

A comprehensive literature search was performed in various databases from database inception to July 2023. The primary outcome was complete biochemical remission rate of AIH. A fixed-effects model was employed when heterogeneity was low, with risk ratios (RR) and 95 % confidence intervals (CIs) reported.

Results

Six studies involving 929 patients were included in the analysis. Among these studies, four were randomized controlled trials (RCTs), while two were cohort studies. The results of the meta-analysis revealed inconsistent findings regarding the complete biochemical remission (CBR) rate between budesonide combined with AZA and predniso(lo)ne combined with AZA in both RCTs and cohort studies. (RCT: RR=1.45, 95 % CI: 1.24 to 1.68; cohort study: RR=0.86, 95 % CI: 0.57 to 1.28). The meta-analysis revealed that the combination of budesonide and AZA was associated with a reduced occurrence of adverse events (AEs) (RCT: RR=0.49, 95 % CI: 0.35 to 0.69; cohort study: RR=0.61, 95 % CI: 0.43 to 0.88) and steroid-related AEs (RCT: RR=0.51, 95 % CI: 0.35 to 0.74; cohort study: RR=0.64, 95 % CI: 0.44 to 0.95).

Conclusion

The combination of budesonide and AZA may offer potential advantages in terms of efficacy and safety for populations with less severe liver damage or lower ALT/AST levels, although the certainty of evidence is currently low to very low.

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布地奈德联合硫唑嘌呤与普瑞尼索联合硫唑嘌呤治疗自身免疫性肝炎的疗效和安全性：系统评价和荟萃分析

背景与目的：布地奈德联合硫唑嘌呤（AZA）治疗自身免疫性肝炎（AIH）的疗效和安全性尚不确定。本研究旨在比较两种联合用药方案的疗效和安全性。方法：从数据库建立到2023年7月，在各数据库中进行全面的文献检索。主要观察指标为AIH生化完全缓解率。当异质性较低时，采用固定效应模型，报告95%置信区间（ci）的风险比（RR）。结果：6项研究共纳入929例患者。其中4项为随机对照试验（rct）， 2项为队列研究。荟萃分析的结果显示，在随机对照试验和队列研究中，布地奈德联合AZA和泼尼索联合AZA的完全生化缓解率（CBR）不一致。（RCT: RR=1.45, 95% CI: 1.24 ~ 1.68；队列研究：RR=0.86, 95% CI: 0.57 ~ 1.28）。荟萃分析显示，布地奈德联合AZA可降低不良事件（ae）（RCT: RR=0.49, 95% CI: 0.35 ~ 0.69；队列研究：RR=0.61, 95% CI: 0.43 ~ 0.88）和类固醇相关ae （RCT: RR=0.51, 95% CI: 0.35 ~ 0.74；队列研究：RR=0.64, 95% CI: 0.44 ~ 0.95）的发生率。结论：布地奈德联合AZA对于肝损害程度较轻或ALT/AST水平较低的人群在疗效和安全性方面可能具有潜在优势，尽管证据的确定性目前较低至非常低。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinics and research in hepatology and gastroenterology GASTROENTEROLOGY & HEPATOLOGY-

CiteScore

4.30

自引率

3.70%

发文量

198

审稿时长

42 days

期刊介绍： Clinics and Research in Hepatology and Gastroenterology publishes high-quality original research papers in the field of hepatology and gastroenterology. The editors put the accent on rapid communication of new research and clinical developments and so called "hot topic" issues. Following a clear Editorial line, besides original articles and case reports, each issue features editorials, commentaries and reviews. The journal encourages research and discussion between all those involved in the specialty on an international level. All articles are peer reviewed by international experts, the articles in press are online and indexed in the international databases (Current Contents, Pubmed, Scopus, Science Direct). Clinics and Research in Hepatology and Gastroenterology is a subscription journal (with optional open access), which allows you to publish your research without any cost to you (unless you proactively chose the open access option). Your article will be available to all researchers around the globe whose institution has a subscription to the journal.