瘘管是克罗恩病 (CD) 的一种使人衰弱的并发症。我们进行了一项系统评价，以评估药物治疗对瘘管性 CD 的疗效。于 2022 年 5 月 26 日检索了 MEDLINE、Embase 和 CENTRAL，以查找成人瘘管性 CD 药物治疗的随机对照试验 (RCT)。主要结果是瘘管反应的诱导和维持。计算汇总风险比 (RR) 和 95% 置信区间 (CI)。 GRADE 用于评估证据的确定性。纳入了 38 项随机对照试验。十九项试验（50%）专门涉及肛周瘘。其余的研究包括一些患有非肛周瘘的参与者。抗肿瘤坏死因子 (TNF) 药物的汇总 RR 对于诱导（RR 1.36，95% CI 0.97-1.91）或维持瘘管反应（RR 1.48，95% CI 0.97-2.27）没有统计学意义。然而，在以瘘管反应为主要结局的研究的敏感性分析中，抗 TNF 药物在诱导（RR 1.94，95% CI 1.10-3.41）和维持（RR 1.88，95% CI 1.23-2.88）方面优于安慰剂。瘘管反应。口服小分子（RR 2.56，95% CI 1.18-5.53）和间充质干细胞（MSC）治疗（RR 1.26，95% CI 1.01-1.57）可有效诱导瘘管反应。乌司奴单抗与维持瘘管反应相关（RR 1.80，95% CI1.04-3.11）。维多珠单抗并不优于安慰剂。证据质量从极低到中等。极低到中等质量证据表明抗 TNF 疗法、口服小分子、优特克单抗和 MSC 对肛周瘘管 CD 有效。需要专门评估生物制剂和小分子的瘘管研究。© 作者 2023。由牛津大学出版社代表欧洲克罗恩病和结肠炎组织出版。版权所有。如需权限，请发送电子邮件至：journals.permissions@oup.com。

Fistulas are a debilitating complication of Crohn's disease (CD). We conducted a systematic review to assess the efficacy of medical therapies for fistulising CD.MEDLINE, Embase, and CENTRAL were searched on May 26, 2022, for randomised controlled trials (RCTs) of pharmacologic therapy in adults with fistulising CD. The primary outcome was induction and maintenance of fistula response. Pooled risk ratios (RRs) and 95% confidence intervals (CI) were calculated. GRADE was used to assess certainty of evidence.Thirty-eight RCTs were included. Nineteen trials (50%) exclusively involved perianal fistula. The remaining studies included some participants with non-perianal fistula. Pooled RRs for anti-tumor necrosis factor (TNF) agents were not statistically significant for induction (RR 1.36, 95% CI 0.97-1.91) or maintenance of fistula response (RR 1.48, 95% CI 0.97-2.27). However, in a sensitivity analysis of studies with fistula response as the primary outcome, anti-TNFs were superior to placebo for induction (RR 1.94, 95% CI 1.10-3.41) and maintenance (RR 1.88, 95% CI 1.23-2.88) of fistula response. Oral small molecules (RR 2.56, 95% CI 1.18-5.53) and mesenchymal stem cell (MSC) therapy (RR 1.26, 95% CI 1.01-1.57) were effective for induction of fistula response. Ustekinumab was associated with maintenance of fistula response (RR 1.80, 95% CI1.04-3.11). Vedolizumab was not superior to placebo. The certainty of evidence ranged from very low to moderate.Very low-to-moderate certainty evidence suggests that anti-TNF therapy, oral small molecules, ustekinumab, and MSCs are effective for perianal fistulising CD. Dedicated fistula studies evaluating biologics and small molecules are needed.© The Author(s) 2023. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.