小分子药物治疗中重度溃疡性结肠炎疗效和安全性的meta分析  

Efficacy and Safety of Small Molecule Drugs in Treatment of Moderate⁃to⁃severe Ulcerative Colitis:A Meta⁃analysis

作　　者：高建淑 李健 张龙祥 高鸿亮[1] GAO Jianshu;LI Jian;ZHANG Longxiang;GAO Hongliang(The Second Department of Gastroenterology,the First Affiliated Hospital of Xinjiang Medical University,Urumqi,830054)

机构地区：[1]新疆医科大学第一附属医院消化病二科,830054

出　　处：《胃肠病学》2024年第8期465-474,共10页Chinese Journal of Gastroenterology

基　　金：国家自然科学基金(82460109);新疆维吾尔自治区自然科学基金杰出青年科学基金(2022D01E25);新疆维吾尔自治区卫生健康青年医学科技人才专项科研项目(WJWY⁃202402)。

摘　　要：背景:溃疡性结肠炎(UC)是一种慢性非特异性疾病,具有潜在致残性,其临床治疗手段以药物为主,目前小分子药物(SMDs)显示出良好的应用前景。目的:探讨SMDs治疗中重度UC的疗效和安全性。方法:检索中国知网、万方、维普、中国生物医学文献数据库、PubMed、Cochrane Library和Embase数据库中SMDs治疗中重度UC的随机对照试验(RCTs),检索时限均为建库至2024年3月。按照纳入和排除标准筛选文献并提取数据,采用RevMan 5.3软件行meta分析。结果:最终共纳入16篇文献、24项RCTs。Meta分析结果显示SMDs治疗中重度UC的诱导期临床应答率(RR=1.93,95%CI:1.60~2.32,P<0.00001)、诱导期临床缓解率(RR=2.96,95%CI:2.14~4.10,P<0.00001)、诱导期黏膜愈合率(RR=2.84,95%CI:2.19~3.66,P<0.00001)和持续临床缓解率(RR=3.76,95%CI:3.05~4.64,P<0.00001)均显著高于安慰剂,而诱导期不良反应发生率(RR=1.03,95%CI:0.97~1.09,P=0.33)、严重不良反应发生率(JAK抑制剂:RR=0.76,95%CI:0.56~1.02,P=0.07;S1P受体调节剂:RR=0.72,95%CI:0.43~1.20,P=0.21)和不良反应导致的停药率(RR=0.78,95%CI:0.59~1.02,P=0.07)与安慰剂相比均无明显差异。结论:SMDs治疗中重度UC的疗效显著,且安全性良好,为UC的治疗提供了新思路。Background:Ulcerative colitis(UC)is a chronic non⁃specific disorder with the potential to cause disability.At present,the clinical treatment mainly involves drug interventions,among which small molecule drugs(SMDs)have demonstrated promising therapeutic potential.Aims:To explore the efficacy and safety of SMDs in the treatment of moderate⁃to⁃severe UC.Methods:Randomized controlled trials(RCTs)of SMDs in treatment of moderate⁃to⁃severe UC were retrieved from CNKI,Wanfang Data,VIP,China Biomedical Literature Database,PubMed,Cochrane Library and Embase from the establishment of each database to March 2024.Literatures were enrolled according to inclusion and exclusion criteria,and the data were extracted.Meta⁃analysis was performed by RevMan 5.3 software.Results:A total of 16 literatures including 24 RCTs were finally enrolled.Meta⁃analysis showed that the clinical response rate(RR=1.93,95%CI:1.60⁃2.32,P<0.00001),clinical remission rate(RR=2.96,95%CI:2.14⁃4.10,P<0.00001),mucosal healing rate(RR=2.84,95%CI:2.19⁃3.66,P<0.00001)in induction therapy and the sustained clinical remission rate(RR=3.76,95%CI:3.05⁃4.64,P<0.00001)of SMDs in the treatment of moderate⁃to⁃severe UC were significantly higher than those of placebo.No significant differences in the incidence of adverse reactions(RR=1.03,95%CI:0.97⁃1.09,P=0.33),incidence of serious adverse reactions(JAK inhibitors:RR=0.76,95%CI:0.56⁃1.02,P=0.07;S1P receptor modulators:RR=0.72,95%CI:0.43⁃1.20,P=0.21),and the incidence of drug withdrawal caused by adverse reactions(RR=0.78,95%CI:0.59⁃1.02,P=0.07)were found between SMDs and placebo in induction therapy.Conclusions:SMDs are effective and safe in treatment of moderate⁃to⁃severe UC patients,which provides a new idea for management of UC.

关 键 词：结肠炎 溃疡性 小分子药物 治疗 安全 META分析 

分 类 号：R574.62[医药卫生—消化系统]