英夫利西單抗和烏司奴單抗在中重度炎癥性腸病一線生物治療中療效和安全性的比較：間接meta分析

背景：隨著生物制劑種類的增加，治療中重度克羅恩?。–D）和中重度潰瘍性結腸炎（UC）的一線生物制劑需要更精準的定位。目的：系統性評價英夫利西單抗（IFX）和烏司奴單抗（UST）在中重度CD和中重度UC一線生物治療中的療效和安全性。方法：檢索中國知網、萬方、維普、中國科學引文數據庫、PubMed、Web of Science、Embase、ClinicalTrials、Cochrane Library等數據庫中IFX和UST治療中重度CD和UC的隨機對照試驗（RCT），檢索時間為建庫至2023年12月。采用間接meta分析比較IFX與UST治療中重度CD和UC的療效和安全性。結果：最終納入11項RCT。IFX誘導和維持中重度CD的臨床緩解率與UST相比差異無統計學意義（Pgt;0.05），嚴重不良事件和嚴重感染發生率差異亦無統計學意義（Pgt;0.05）。IFX誘導和維持中重度UC的臨床緩解率與UST相比差異無統計學意義（Pgt;0.05），嚴重不良事件和嚴重感染發生率差異亦無統計學意義（Pgt;0.05）。結論：在中重度CD患者中，IFX和UST可作為一線生物治療的平行選擇，考慮到IFX可增加患者感染結核的風險，推薦UST作為首選療法。在中重度UC患者中，IFX是有效、安全的一線生物制劑，UST可作為一線生物治療的選擇之一。

關鍵詞 一線生物療法； 英夫利西單抗； 烏司奴單抗； Crohn?。?結腸炎， 潰瘍性； 間接meta分析

Comparison of Efficacy and Safety of Infliximab and Ustekinumab in First?line Biological Therapy for Moderate?to?severe Inflammatory Bowel Disease： An Indirect Meta?analysis GAN Yujia， ZHOU Linyan. Department of Gastroenterology， Shengjing Hospital of China Medical University， Shenyang （110004）

Correspondence to： ZHOU Linyan， Email： enej329@outlook.com

Background： With the increasing diversity of biological agents， the first?line biological agents for moderate?to?severe Crohn's disease （CD） and ulcerative colitis （UC） requires more precise positioning. Aims： To systematically evaluate the efficacy and safety of infliximab （IFX） and ustekinumab （UST） as first?line options for moderate?to?severe CD and UC. Methods： Randomized controlled trials （RCTs） on IFX and UST in treatment of moderate?to?severe CD and UC were retrieved from CNKI， Wanfang data， VIP， Chinese Science Citation Database and PubMed， Web of Science， Embase， ClinicalTrials， Cochrane Library from the date of database establishment to December 2023. An indirect meta?analysis was conducted to compare the efficacy and safety of IFX and UST in treatment of moderate?to?severe CD and UC. Results： Eleven RCTs were enrolled. No significant differences in clinical remission and maintenance rates of moderate?to?severe CD were found between IFX group and UST group （Pgt;0.05）， and no significant differences in serious adverse events and serious infection rates were found between these two groups （Pgt;0.05）. No significant differences in clinical remission and maintenance rates of moderate?to?severe UC were found between IFX group and UST group （Pgt;0.05）， and no significant differences in serious adverse events and serious infection rates were found between these two groups （Pgt;0.05）. Conclusions： Both IFX and UST can be served as first?line biological therapy for patients with moderate?to?severe CD. In view of the fact that IFX can increase the risk of tuberculosis， UST is recommended as first?line therapy for moderate?to?severe CD. For moderate?to?severe UC， IFX is an effective and safe first?line biological therapy， and UST can be served as an alternative.

Key words First?Line Biological Therapy; Infliximab; Ustekinumab; Crohn Disease; Colitis， Ulcerative;

Indirect Meta?Analysis

炎癥性腸?。╥nflammatory bowel disease， IBD）是以復發和緩解交替為特征的自身免疫性炎癥性疾病[1]，包括克羅恩?。–rohn′s disease， CD）和潰瘍性結腸炎（ulcerative colitis， UC），其發病機制涉及遺傳易感性、免疫和環境因素之間的復雜相互作用[2]。在世界范圍內，IBD的發病率正在增加，西方國家的發病率最高[3]。IBD癥狀取決于受累腸道的范圍，通常包括腹瀉、腹痛、胃腸道出血和體質量減輕等。隨著疾病的發展，可能進一步出現狹窄或瘺管等并發癥。……