收稿日期: 2023-12-14
网络出版日期: 2024-04-08
基金资助
“十三五”国家重点研发计划资助(2018YFC1705404)
Short term clinical efficacy and influencing factors of ustekinumab monoclonal antibody in the treatment of Crohn′s disease
Received date: 2023-12-14
Online published: 2024-04-08
目的 探讨乌司奴单克隆抗体(UST)治疗克罗恩病(CD)的短期临床疗效及影响因素,为UST的临床应用提供更多的证据支持。 方法 采用回顾性队列研究方法,收集2020年12月至2022年10月在同济大学附属第十人民医院采用UST治疗的CD患者临床资料。主要分析UST治疗CD第8、16周的短期临床疗效和影响因素,并分析部分患者的内镜缓解率。 结果 共纳入91例初次使用UST的CD患者。UST治疗CD第8/16周的临床应答率分别为61.5%、71.4%,临床缓解率分别为45%、54.9%。单因素分析表明瘘(包括肛瘘、肛瘘个人史、肠皮瘘)与CD第8/16周的临床缓解有关。多因素COX分析提示,有肛瘘手术史相比于无瘘者是影响UST治疗CD第8周(HR = 0.04,95%CI:0.00 ~ 0.38;P < 0.01)和16周(HR = 0.04,95%CI:0.01 ~ 0.34;P < 0.01)临床缓解的独立保护性因素;狭窄型病变相较于非狭窄非穿透性病变,是CD患者16周临床缓解的独立危险因素(HR = 1.75,95%CI:1.08 ~ 2.84;P < 0.05)。56例于我院复查内镜,16周的内镜缓解率为41.1%。未发现有患者因严重不良反应停止用药。 结论 UST能够改善CD第8/16周的临床缓解与临床应答,具有较好的短期临床疗效。有肛瘘个人史的CD患者推荐应用UST单抗,具有狭窄型病变的患者需谨慎应用UST单抗。患者既往是否行手术治疗,以及UST一线或非一线应用,均对临床缓解无明显影响。
王芮 , 刘嫦钦 , 张萃 , 杨清露 , 杨娇兰 , 殷鹏云 , 李晓辉 , 孙永顺 , 刘占举 , 孙晓敏 . 乌司奴单克隆抗体治疗克罗恩病的短期临床疗效及影响因素[J]. 实用医学杂志, 2024 , 40(7) : 989 -995 . DOI: 10.3969/j.issn.1006-5725.2024.07.019
Objective To analyze the short?term clinical efficacy and influencing factors of ustekinumab monoclonal antibody (UST) in the treatment of Crohn's disease (CD). Methods Retrospective cohort study was used to collect the clinical data of CD patients treated with UST in the 10th People's Hospital affiliated to Tongji University from December 2020 to October 2022. The main analysis is the short?term clinical efficacy and influencing factors of UST treatment for CD at weeks 8 and 16, And analyze the endoscopic response rate of some patients. Results A total of 91 CD patients who first used UST were included. The 8?week clinical response rate of UST treatment for CD was 61.5%, and the clinical response rate was 45%; The clinical response rate at 16 weeks was 71.4%, and the clinical response rate was 54.9%. 56 cases underwent endoscopic re?examination in our hospital, and the endoscopic response rate at 16 weeks was 41.1%. Univariate analysis showed that fistula (including anal fistula, personal history of anal fistula, and intestinal skin fistula) is associated with clinical remission in Crohn's disease patients at 8/16 weeks. Further multivariate COX regression analysis showed that the presence of a history of anal fistula surgery was an independent protective factor affecting clinical remission in CD patients treated with UST at 8 weeks (HR = 0.04,95% CI: 0.00 ~ 0.38; P = 0.005) and 16 weeks (HR = 0.04,95% CI: 0.01 ~ 0.34; P = 0.003) compared to those without fistula; Narrow lesions are an independent risk factor for 16 week clinical remission in CD patients compared to non?narrow and non?penetrating lesions (HR = 1.75, 95% CI: 1.08 ~ 2.84; P = 0.023). No patients were found to have stopped medication due to serious adverse reactions. Conclusions UST can improve the clinical remission and response of CD patients at 8/16 weeks, and has good short?term clinical efficacy. CD patients with a personal history of anal fistula are recommended to use UST monoclonal antibodies, while patients with stenotic lesions should be cautious in using UST monoclonal antibodies. Whether the patient has undergone surgical treatment in the past, as well as whether UST has been used on the first or non?first line, has no significant impact on clinical remission.
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