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1-磷酸鞘氨醇受体调节剂治疗炎症性肠病的疗效与安全性:一项系统评价和荟萃分析

Efficacy and safety of sphingosine-1-phosphate receptor modulators in the management of inflammatory bowel disease: a systematic review and meta-analysis.

作者信息

Darmadi Darmadi, Ariestine Dina Aprillia, Ahmad Herwindo, Sitepu Yan Indra Fajar

机构信息

Department of Internal Medicine, Faculty of Medicine, Universitas of Sumatera Utara, Medan, Indonesia.

出版信息

Gastroenterol Hepatol Bed Bench. 2025;18(2):120-131. doi: 10.22037/ghfbb.v18i2.3134.

Abstract

AIM

To evaluate the efficacy and safety of sphingosine-1-phosphate (S1P) receptor modulators in treating ulcerative colitis (UC) and Crohn's disease (CD).

BACKGROUND

Inflammatory Bowel Disease (IBD) is a chronic immune-mediated condition that remains challenging to manage. S1P receptor modulators offer a novel therapeutic approach by targeting immune cell trafficking, potentially improving disease outcomes.

METHODS

A systematic review and meta-analysis were conducted by searching PubMed, Scopus, and Cochrane Library major electronic databases for randomized controlled trials (RCTs) investigating S1P receptor modulators in IBD. Clinical outcomes assessed included clinical remission, clinical response, endoscopic improvement, histologic remission, and serious adverse events. Pooled odds ratios (OR) with 95% confidence intervals (CI) were calculated using a fixed-effects model.

RESULTS

Seven RCTs with a total of 2,597 patients were included. S1P receptor modulators significantly improved clinical remission (OR = 1.49, 95% CI: 1.21-1.84, p < 0.001), histologic remission (OR = 1.74, 95% CI: 1.31-2.31, p < 0.001), endoscopic improvement (OR = 1.58, 95% CI: 1.23-2.04, p < 0.001), and clinical response (OR = 1.27, 95% CI: 1.05-1.54, p = 0.01). The risk of serious adverse events did not significantly differ between treatment and placebo groups (OR = 1.28, 95% CI: 0.92-1.80, p = 0.14), suggesting a favorable safety profile.

CONCLUSION

This meta-analysis supports S1P receptor modulators, particularly ozanimod and etrasimod, as effective and safe treatments for UC. Further studies are needed to assess long-term safety and direct comparisons with existing biologic therapies.

摘要

目的

评估1-磷酸鞘氨醇(S1P)受体调节剂治疗溃疡性结肠炎(UC)和克罗恩病(CD)的疗效及安全性。

背景

炎症性肠病(IBD)是一种慢性免疫介导性疾病,其治疗仍具有挑战性。S1P受体调节剂通过靶向免疫细胞转运提供了一种新的治疗方法,可能改善疾病结局。

方法

通过检索PubMed、Scopus和Cochrane图书馆等主要电子数据库,对研究S1P受体调节剂治疗IBD的随机对照试验(RCT)进行系统评价和荟萃分析。评估的临床结局包括临床缓解、临床反应、内镜改善、组织学缓解和严重不良事件。采用固定效应模型计算合并比值比(OR)及95%置信区间(CI)。

结果

纳入7项RCT,共2597例患者。S1P受体调节剂显著改善临床缓解(OR = 1.49,95%CI:1.21 - 1.84,p < 0.001)、组织学缓解(OR = 1.74,95%CI:1.31 - 2.31,p < 0.001)、内镜改善(OR = 1.58,95%CI:1.23 - 2.04,p < 0.001)和临床反应(OR = 1.27,95%CI:1.05 - 1.54,p = 0.01)。治疗组和安慰剂组严重不良事件风险无显著差异(OR = 1.28,95%CI:0.92 - 1.80,p = 0.14),表明安全性良好。

结论

该荟萃分析支持S1P受体调节剂,尤其是奥扎莫德和艾曲莫德,作为UC的有效且安全的治疗方法。需要进一步研究评估长期安全性,并与现有生物疗法进行直接比较。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2f0/12421927/83cadbc0220d/GHFBB-18-2-120-g001.jpg

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