Objective: To treat the Crohn's disease (CD) patients with ustekinumab (UST), to eva-luate their clinical and endoscopic remission, and to evaluate their transmural response (TR) and transmural healing (TH) condition using intestinal ultrasonography (IUS).
Methods: Retrospective analysis was made on patients diagnosed with CD in Peking University People's Hospital from January 2020 to August 2022, who were treated with UST for remission induction and maintenance therapy. All the patients were evaluated on both week 8 and week 16/20 after treatment, including clinical, biochemical indicators, colonoscopy and IUS examination.
Results: A total of 13 patients were enrolled in this study, including 11 males and 2 females. The minimum age was 23 years, the maximum age was 73 years and the mean age was 36.92 years. All the patients were in the active stage of disease before treatment, and the average Best Crohn's disease activity index (Best CDAI) score was 270.12±105.55. In week 8, the Best CDAI score of the patients decreased from 270.12±105.55 to 133.16±48.66 (t=4.977, P < 0.001). Eight patients achieved clinical remission while 5 patients remained in the active stage. Nine patients underwent colonoscopy evaluation. The average simple endoscopic score for Crohn's disease (SES-CD) score decreased from 10.71±7.14 before treatment to 6.00±7.81(t=2.483, P=0.048) in week 16/20. Four patients achieved endoscopic remission while 5 patients did not. In week 8, 5 patients achieved TR, 2 patients achieved TH, the other 6 patients did not get TR or TH. In week 16/20, 6 patients achieved TR, 3 patients achieved TH while the other 4 patients did not get TR or TH. There was no significant statistical difference in the TR effect of UST between small intestine and colon lesions (Fisher test, P > 0.999). The rate of UST transmural response in the patients who had had previous biological agent therapy was lower than those with no previous biological agent therapy, but there was no significant statistical difference (Fisher test, P=0.491).
Conclusion: After treatment of UST, the clinical and endoscopic conditions of the CD patients had been improved, and some patients could achieve clinical remission and endoscopic remission. UST had good TR and TH effects on CD. TR might appear in week 8, and the TR effect increased in week 16/20. There was no significant statistical difference in the TR effect between small intestine and colon lesions. TR effect of UST was better in the patients who had no previous biological agent therapy than those who had had other biological agents, but the result had no significant statistical difference.
目的: 应用乌司奴单抗(ustekinumab, UST)治疗克罗恩病(Crohn’s disease, CD)患者，评估临床及内镜缓解情况，采用肠道超声(intestinal ultrasonography, IUS)评估透壁应答(transmural response, TR)与透壁愈合(transmural healing, TH)情况。
方法: 回顾性分析2020年1月到2022年8月北京大学人民医院所有确诊应用UST进行治疗的CD患者，分别于治疗后8周、治疗后16/20周进行评估，包括临床、生化学指标、结肠镜及IUS检查。
结果: 共纳入患者13例，其中男性11例，女性2例，平均年龄36.92岁，治疗前Best克罗恩病活动指数(Best Crohn’s disease activity index, Best CDAI)平均值为270.12±105.55。在治疗8周时，患者的Best CDAI评分下降至133.16± 48.66 (t=4.977，P＜0.001)，8例患者达到临床缓解，5例未达到临床缓解。共有9例患者治疗前后进行结肠镜检查评估，治疗前进行简化克罗恩病内镜下评分(simple endoscopic score for Crohn’s disease，SES-CD)，评分为10.71± 7.14，16/20周复查SES-CD下降至6.00±7.81(t=2.483，P=0.048)，其中4例患者达到内镜缓解，5例患者未达到内镜缓解。在8周时，13例患者中有5例达到TR，2例达到TH，6例未达到TR或TH。16/20周时，6例患者达到TR，3例达到TH，4例未达到TR或TH。UST对于小肠和结肠病变的TR效果差异无统计学意义(Fisher精确概率检验，P＞0.999)。既往应用过其他生物制剂的患者中UST的TR偏低，但差异无统计学意义(Fisher精确概率检验，P=0.491)。
结论: 应用UST 16/20周后患者的临床情况及内镜下评估均有改善，部分患者可以达到临床缓解及内镜缓解；UST对CD患者具有较好的TR效果，在8周即出现TR，16/20周TR有所增加；UST对小肠和结肠病变的TR效果差异无统计学意义；既往未应用过其他生物制剂的患者UST的TR较既往使用过生物制剂的患者效果更好，但差异无统计学意义。
Keywords: Crohn's disease; Transmural healing; Transmural response; Ustekinumab.