Gastrounit, Medical Division, Copenhagen University Hospital, Hvidovre, Denmark.
Copenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults, University of Copenhagen, Hvidovre Hospital, Hvidovre, Denmark.
Scand J Gastroenterol. 2021 Jan;56(1):53-58. doi: 10.1080/00365521.2020.1854848. Epub 2020 Dec 2.
Although the number of biological therapies for the treatment of Crohn's disease (CD) is rapidly increasing, their efficacy in inducing healing of fistulas in perianal Crohn's disease (pCD) is practically unknown, although they occur in up to 50% of patients with CD.
We aimed to investigate the clinical effectiveness of ustekinumab for pCD in a systemic review and meta-analysis.
Studies describing the efficacy of ustekinumab on fistulas in pCD in PubMed and EMBASE database from inception until 22 September 2020, were assessed in a systemic review and meta-analysis. The random-effect model was applied for the meta-analysis.
The systematic review of the current literature yielded 2,243 studies of which nine studies with a total of 396 patients were found eligible for inclusion. The pooled proportions of patients experiencing fistula response were 41.0% (95% CI 23.9-60.6%9), = 85%, 39.7% (95% CI 24.3-57.4%), = 69% and 55.9% (95% CI 40.8-69.9%, = 67% at weeks 8, 24, and 52, respectively. Regarding fistula remission, the pooled proportions were 17.1% (95% CI 8.1-32.7%), = 45%, 17.7% (95% CI 1.8-71.9%), = 68%, and 16.7% (95% CI 3.0-56.5%, = 51% at week 8, 24, and 52, respectively.
In this systematic review with meta-analysis, we found a signal of efficacy of ustekinumab on fistulizing pCD, emphasizing that these patients might benefit from this therapy.
虽然用于治疗克罗恩病（CD）的生物疗法数量正在迅速增加，但实际上尚不清楚它们在诱导肛周克罗恩病（pCD）瘘管愈合方面的疗效，尽管多达 50%的 CD 患者会出现瘘管。
我们旨在通过系统评价和荟萃分析研究乌司奴单抗治疗 pCD 的临床疗效。
从建立到 2020 年 9 月 22 日，在 PubMed 和 EMBASE 数据库中评估了描述乌司奴单抗治疗 pCD 瘘管疗效的研究，进行了系统评价和荟萃分析。采用随机效应模型进行荟萃分析。
对当前文献的系统综述产生了 2243 项研究，其中发现 9 项研究共纳入 396 例患者符合纳入标准。患者出现瘘管反应的汇总比例分别为 41.0%（95%CI 23.9-60.6%，9 = 85%）、39.7%（95%CI 24.3-57.4%，9 = 69%）和 55.9%（95%CI 40.8-69.9%，9 = 67%），分别在第 8、24 和 52 周。关于瘘管缓解，汇总比例分别为 17.1%（95%CI 8.1-32.7%，9 = 45%）、17.7%（95%CI 1.8-71.9%，9 = 68%）和 16.7%（95%CI 3.0-56.5%，9 = 51%），分别在第 8、24 和 52 周。
在这项系统评价和荟萃分析中，我们发现乌司奴单抗治疗瘘管性 pCD 有效，这强调这些患者可能从这种治疗中获益。
