Darvadstrocel治疗克罗恩病复杂性肛周瘘:系统回顾和荟萃分析。

IF 5.8 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY United European Gastroenterology Journal Pub Date : 2024-10-03 DOI:10.1002/ueg2.12673
Carlos Taxonera, Miguel A García-Brenes, David Olivares, Olga N López-García, Raúl Zapater, Cristina Alba
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引用次数: 0

摘要

背景:darvadstrocel是一种扩增的脂肪来源异基因间充质干细胞悬浮液,已被用于治疗克罗恩病(CD)难治性肛周瘘:本研究旨在探讨darvadstrocel治疗克罗恩病复杂性肛周瘘的有效性和安全性:方法:在2024年4月之前,在相关数据库中对评估 darvadstrocel 的观察性研究进行了系统检索。采用随机效应荟萃分析模型计算疗效和安全性结果的汇总效应大小(比例或发病率 [IRs])及 95% 置信区间 (CIs)。采用乔安娜-布里格斯研究所的关键评估工具对偏倚风险进行了评估。I2 值评估了异质性。此外,还进行了敏感性分析和亚组分析:结果:共纳入 12 项研究,595 名患者。临床缓解(定义为瘘管愈合)患者在第6个月和第12个月的总比例分别为68.1%(95% CI为63.4-72.7)和77.2%(95% CI为70.1-83.8)。在第 6 个月和第 12 个月时,分别有 60.6% 和 69.7% 的患者获得了综合缓解,综合缓解的定义是临床缓解且经磁共振成像确认没有大于 2 厘米的集合体。治疗失败率为 34.5%,即在最后一次随访(平均 18.7 个月;标清 9.9)时无临床缓解。失败率与随访时间无关(P = 0.85)。在有效性结果方面,研究间的异质性可以忽略不计。亚组分析表明,没有一个协变量会改变治疗效果。每100患者年不良事件(AE)、严重AE、肛周脓肿和再次手术的汇总IR分别为19.6、3.2、16.9和7.1:来自观察性研究的证据支持达伐斯特罗塞治疗 CD 患者复杂肛周瘘的有效性和安全性。研究报告显示,大多数患者的瘘管愈合率很高,而且可以长期维持,研究间的异质性可以忽略不计,安全性也很好。
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Darvadstrocel for complex perianal fistulas in Crohn's disease: A systematic review and meta-analysis.

Background: Local injection of darvadstrocel, a suspension of expanded adipose-derived allogenic mesenchymal stem cells, has been used for treatment-refractory perianal fistulas in Crohn's disease (CD).

Objective: This study aimed to investigate efficacy and safety of darvadstrocel for complex perianal fistulas in CD.

Methods: A systematic search was conducted through April 2024 in relevant databases for observational studies evaluating darvadstrocel. A random-effects meta-analysis model was used to calculate the pooled effect sizes (proportions or incidence rates [IRs]) with 95% confidence intervals (CIs) of effectiveness and safety outcomes. The risk of bias was evaluated using the Joanna Briggs Institute Critical Appraisal Tool. The I2 value assessed heterogeneity. Sensitivity and subgroup analyses were also conducted.

Results: Twelve studies were included with 595 patients. The pooled rate of patients achieving clinical remission, defined as fistula healing, was 68.1% at month 6 (95% CI 63.4-72.7) and 77.2% (95% CI 70.1-83.8) at month 12. Combined remission, defined as clinical remission and absence of collections >2 cm confirmed by magnetic resonance imaging, was reported in 60.6% and in 69.7% of patients at months 6 and 12, respectively. The rate of patients with treatment failure, defined as no clinical remission at the last follow-up (mean 18.7 months; SD 9.9), was 34.5%. Failure rate was independent of follow-up time (p = 0.85). For effectiveness outcomes, between-study heterogeneity was negligible. Subgroup analysis indicated that none of the covariates modified the treatment effect. Pooled IRs per 100 patient-years of adverse events (AE), serious AEs, perianal abscesses, and reoperations were 19.6, 3.2, 16.9 and 7.1, respectively.

Conclusion: Evidence from observational studies supports the efficacy and safety of darvadstrocel for complex perianal fistulas in CD. Studies have reported high fistula healing rates that can be sustained long-term in most patients, with negligible between-study heterogeneity, as well as a favorable safety profile.

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来源期刊
United European Gastroenterology Journal
United European Gastroenterology Journal GASTROENTEROLOGY & HEPATOLOGY-
CiteScore
10.50
自引率
13.30%
发文量
147
期刊介绍: United European Gastroenterology Journal (UEG Journal) is the official Journal of the United European Gastroenterology (UEG), a professional non-profit organisation combining all the leading European societies concerned with digestive disease. UEG’s member societies represent over 22,000 specialists working across medicine, surgery, paediatrics, GI oncology and endoscopy, which makes UEG a unique platform for collaboration and the exchange of knowledge.
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