Mesenchymal stem cell-derived exosomes for complex perianal fistula ‒ A systematic review and single-arm meta-analysis.

IF 4 4区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY

Revista Espanola De Enfermedades Digestivas Pub Date : 2025-09-29 DOI:10.17235/reed.2025.11470/2025

Fang Cheng, Xia Chen, Ying Liao

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Abstract

Objectives: We performed a single-arm meta-analysis to evaluate the efficacy and safety of MSC-Exos in the treatment of complex PFs.

Methods: This systematic review followed PRISMA guidelines and included studies published up to March 20, 2025. We searched four databases for studies evaluating efficacy and/or safety of MSC-Exos for complex PFs. Analyses were performed using R statistical software version 4.4.0.

Results: The analysis of three studies included in this study suggested that MSC-Exos were effective in achieving complete healing in 57% of patients with complex PFs (95% confidence interval (CI) 0.43, 0.76). The pooled data further indicated that MSC-Exos could achieve complete healing in 68% of complex fistula tracts (95% CI 0.59, 0.80). Pooled analysis also showed that 86% (95% CI 0.75,0.98) of patients with complex PFs achieved clinical response post treatment, whereas 18% (95% CI 0.09, 0.37) demonstrated no clinical response after MSC-Exos treatment. Subgroup analysis revealed a higher healing rate (HR) in patients with Crohn's disease (CD) compared to those without CD (60% vs. 57%, respectively), with no statistically significant differences (P > 0.05). Notably, neither systemic nor local adverse effects have been reported in any study.

Conclusion: This meta-analysis highlights the efficacy and safety of local administration of MSC-Exos in patients with complex PFs, offering valuable evidence to guide future clinical practice.

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间充质干细胞衍生的外泌体治疗复杂肛周瘘-系统回顾和单臂荟萃分析。

目的：我们进行了一项单臂荟萃分析，以评估MSC-Exos治疗复杂PFs的有效性和安全性。方法：本系统综述遵循PRISMA指南，纳入截至2025年3月20日发表的研究。我们检索了四个数据库，以评估MSC-Exos治疗复杂PFs的疗效和/或安全性。采用R统计软件4.4.0进行分析。结果：本研究纳入的三项研究的分析表明，MSC-Exos对57%的复杂PFs患者有效实现完全愈合（95%置信区间（CI） 0.43, 0.76）。综合数据进一步表明，MSC-Exos可以在68%的复杂瘘道中实现完全愈合（95% CI 0.59, 0.80）。合并分析还显示，86% （95% CI 0.75,0.98）的复杂PFs患者在治疗后获得临床缓解，而18% （95% CI 0.09, 0.37）的患者在MSC-Exos治疗后没有临床缓解。亚组分析显示，克罗恩病（CD）患者的治愈率（HR）高于非CD患者（分别为60%和57%），差异无统计学意义（P < 0.05）。值得注意的是，在任何研究中均未报告全身性或局部不良反应。结论：本荟萃分析强调了局部给药MSC-Exos治疗复杂PFs患者的有效性和安全性，为指导未来的临床实践提供了有价值的证据。

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

Revista Espanola De Enfermedades Digestivas 医学-胃肠肝病学

CiteScore

2.00

自引率

25.00%

发文量

400

审稿时长

6-12 weeks

期刊介绍： La Revista Española de Enfermedades Digestivas, Órgano Oficial de la Sociedad Española de Patología Digestiva (SEPD), Sociedad Española de Endoscopia Digestiva (SEED) y Asociación Española de Ecografía Digestiva (AEED), publica artículos originales, editoriales, revisiones, casos clínicos, cartas al director, imágenes en patología digestiva, y otros artículos especiales sobre todos los aspectos relativos a las enfermedades digestivas.