乌司奴单抗治疗克罗恩病肛周瘘管的有效性和安全性分析

Efficacy and safety of ustekinumab in treating perianal fistulizing Crohn′s disease: a meta-analysis

目的 系统性评价乌司奴单抗治疗克罗恩病肛周瘘管的疗效,为其临床应用提供理论依据。方法 检索PubMed、Web of Science数据库自建库以来至2022年6月前公开发表的有关乌司奴单抗治疗克罗恩病相关肛周瘘管的随机对照研究及非随机对照研究。按照纳入及排除标准对文献进行筛选。对最终纳入的8篇文献进行质量分析,并使用统计软件RevMan5.4对收集的数据进行meta分析。结果 研究共纳入8项随机及非随机对照研究(共包含427例活动性克罗恩病肛周瘘管患者),分析显示乌司奴单抗治疗克罗恩病肛周瘘管的瘘管反应率为21%(I2=47%,P <0.01)和瘘管缓解率为20%(I2=46%,P <0.01)。在安全性方面,系统性分析表明乌司奴单抗治疗克罗恩病肛周瘘管的不良事件[OR=1.10,95%CI1.07~1.13,Z=7.54(P<0.01),I2=0%]。结论 据现有的文献资料可知,乌司奴单抗治疗克罗恩病肛周瘘管是有效和安全的。

ObjectiveTo systematically evaluate the efficacy of ustekinumab(UST)in treating perianal fistulizing Crohn′s disease(CD), so as to provide a theoretical basis for its clinical application.MethodsRandomized controlled and non-randomized controlled studies of UST in the treatment of CD related perianal fistulas published in PubMed and Web of Science databases from the establishment of the database to June 2022 were searched.The literatures were screened according to inclusion and exclusion criteria.Quality analysis were performed on the 8 articles finally included, and statistical software RevMan5.4 was used for meta-analysis of the collected data.ResultsA total of 8 randomized and non-randomized controlled studies(including 427 patients with active perianal fistulizing CD)were included in this study.Analysis showed that UST treated perianal fistulizing CD with a fistula response rate of 21%(I2=47%, P<0.01)and a fistula relief rate of 20%(I2=46%, P<0.01). In terms of safety, systematic analysis of adverse events that UST treated perianal fistulizing CD showed that OR=1.10, 95% CI: 1.07-1.13, Z=7.54, P<0.01, and I2=0%.ConclusionAccording to the available literatures, UST is effective and safe in the treatment of perianal fistulizing CD.