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乌司奴单抗治疗克罗恩病的短期疗效:一项中国真实世界回顾性多中心研究的结果

Short-Term Effectiveness of Ustekinumab in Crohn's Disease: Results from a Real-World Retrospective Multicenter Study in China.

作者信息

Zhu Xiuli, Fang Xiaoli, Wang Qiaomin, Li Ming, Zhang Kaiguang, Xie Li, Niu Xiaoping, Wang Song

机构信息

Department of Gastroenterology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, 230002, People's Republic of China.

Department of Anorectal Surgery, First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei, 230031, People's Republic of China.

出版信息

Int J Gen Med. 2025 May 20;18:2589-2597. doi: 10.2147/IJGM.S520984. eCollection 2025.

Abstract

BACKGROUND

There are few data on ustekinumab treatment for Crohn's disease (CD) in a Chinese population. Our study is a real-world retrospective multicenter study aimed at exploring the effectiveness of ustekinumab in CD patients and comparing the effectiveness of first line and second line treatments.

METHODS

Laboratory indicators, CD activity index (CDAI) and simple endoscopic score for CD (SES-CD) scores of patients at the 8th, 16th and 24th weeks of treatment were collected, and the clinical remission rate, clinical response rate, endoscopic remission rate and endoscopic response rate were calculated, and the patients were divided into first line group and second line group for comparison.

RESULTS

A total of 102 patients were treated with ustekinumab, and 56 patients with a clinical data integrity rate greater than 70% were ultimately included. The clinical remission rate of the patients gradually increased at the 8th, 16th and 24th weeks of treatment, which were 34 cases (60.7%), 37 cases (66.1%) and 49 cases (87.5%), respectively. The clinical response rates for 8th, 16th and 24th weeks were 38 (67.8%), 42 (0.75%) and 51 (91.1%), respectively, and the endoscopic remission rate was 4% (2/50) at the 24th week. The clinical response rates of the first line group were higher than those of the second line group at the 16th and 24th weeks, with statistically significant differences. The clinical response time of patients receiving first line or second line treatment with ustekinumab was different, and the first line treatment group achieved clinical response more quickly.

CONCLUSION

Ustekinumab is effective in the short-term treatment of CD patients in China, with first line treatment superior to second line treatment and faster than second line treatment.

摘要

背景

关于乌司奴单抗治疗中国人群克罗恩病(CD)的数据较少。我们的研究是一项真实世界的回顾性多中心研究,旨在探讨乌司奴单抗对CD患者的有效性,并比较一线和二线治疗的有效性。

方法

收集患者在治疗第8周、第16周和第24周的实验室指标、CD活动指数(CDAI)和CD的简单内镜评分(SES-CD)评分,计算临床缓解率、临床反应率、内镜缓解率和内镜反应率,并将患者分为一线组和二线组进行比较。

结果

共有102例患者接受乌司奴单抗治疗,最终纳入56例临床数据完整性率大于70%的患者。患者的临床缓解率在治疗第8周、第16周和第24周逐渐升高,分别为34例(60.7%)、37例(66.1%)和49例(87.5%)。第8周、第16周和第24周的临床反应率分别为38例(67.8%)、42例(75.0%)和51例(91.1%),第24周的内镜缓解率为4%(2/50)。一线组在第16周和第24周的临床反应率高于二线组,差异有统计学意义。接受乌司奴单抗一线或二线治疗的患者临床反应时间不同,一线治疗组达到临床反应更快。

结论

乌司奴单抗在中国CD患者的短期治疗中有效,一线治疗优于二线治疗且起效比二线治疗更快。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/540d/12103174/756c28fc0289/IJGM-18-2589-g0001.jpg

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