摘要
目的评估乌司奴单克隆抗体(UST)治疗难治性克罗恩病(CD)的短期疗效。方法回顾性收集2020年3月1日至9月30日中山大学附属第六医院、浙江大学医学院附属第二医院以及陆军军医大学新桥医院采用UST治疗的难治性CD患者的临床资料。患者在第0、8、16/20周分别使用推荐剂量UST。采用克罗恩病疾病活动指数(CDAI)评估患者临床应答和缓解情况。采用克罗恩病简化内镜评分(SES-CD)评估内镜应答和缓解情况。采用炎症性肠病生存质量量表(IBDQ)评估生活质量。统计分析UST治疗后第8周和(或)第16/20周的临床、内镜应答情况和IBDQ评分,并比较分析第0、8、16/20周的体质量指数(BMI)、白蛋白、血红蛋白、C-反应蛋白(CRP)、红细胞沉降率(ESR)的差异。结果共纳入18例CD患者,男性12例,女性6例;年龄30.5(26.0,38.0)岁;病程6.5(1.9,10.0)年。蒙特利尔分型中,诊断年龄17~40岁15例(83.3%),回结肠型13例(72.2%),非狭窄非穿透型14例(77.8%)。10例(55.6%)患者合并肛周疾病,6例(33.3%)患者曾经接受手术治疗。曾使用糖皮质激素11例(61.1%)患者,使用免疫抑制剂13例(72.2%),使用生物制剂16例(88.9%)。使用UST第8周时,72.2%(13/18)患者达到临床缓解,77.8%(14/18)患者具有临床应答;第16/20周时,88.9%(16/18)患者达到临床缓解,94.4%(17/18)患者具有临床应答;第16/20周内镜缓解率为28.6%(4/14),内镜应答率为78.6%(11/14)。第8周、第16/20周时患者的BMI[(21.0±0.5)kg/m^(2)和(21.7±0.4)kg/m^(2)比(19.9±0.6)kg/m^(2),均P<0.05]、白蛋白[(41.7±3.7)g/L和(41.7±3.7)g/L比(39.6±4.6)g/L,均P<0.05]、血红蛋白[(134.9±12.0)g/L和(135.9±12.3)g/L比(126.7±15.8)g/L,均P<0.05]均较第0周显著增加,第8周、第16/20周CRP较第0周显著下降[10.2(5.1,17.5)mg/L和7.6(3.2,14.7)mg/L比15.5(12.3,31.4)mg/L,均P<0.05]。第16/20周时患者的ESR和IBDQ评分较第0周差异均无统计学意义(均P>0.05)。结论UST短期内可有效改善难治性CD患者的临床症状和内镜下表现。
Objective To assess the short-term efficacy of ustekinumab(UST)in the treatment of intractable Crohn′s disease(CD).Methods Clinical data of intractable CD patients with the administration of UST in the Sixth Affiliated Hospital of Sun Yat-sen University,the Second Affiliated Hospital of Zhejiang University School of Medicine and Xinqiao Hospital of Army Medical University from March 1st to September 30th,2020 were analyzed retrospectively.All of the patients started UST at the recommended dose at 0,8th,16th/20th weeks.The clinical response and remission were evaluated by Crohn′s disease activity index(CDAI).The endoscopic response and remission were evaluated by simple endoscopic score for Crohn′s disease(SES-CD).The life quality was evaluated by inflammatory bowel disease questionnaire(IBDQ).The clinical and endoscopic responses and IBDQ scores were analyzed statistically at 8th week and(or)at 16th/20th week.The differences in body mass index(BMI),albumin,hemoglobin,C-reactive protein(CRP)and erythrocyte sedimentation rate(ESR)among 0,8th,16th/20th weeks after UST treatment were compared and analyzed.Results A total of 18 CD patients were enrolled,including 12 males and 6 females.The age was 30.5(26.0,38.0)years old while the disease duration was 6.5(1.9,10.0)years.According to Montreal classification,15(83.3%)patients were diagnosed at the age from 17 to 40 years old,the disease involved the ileocolon in 13(72.2%)patients and the non-stricturing non-penetrating type was in 14(77.8%)patients.Ten(55.6%)patients were complicated with perianal disease and 6(33.3%)patients had undergone surgeries.Eleven(61.1%)patients had received treatment of glucocorticoids,13(72.2%)patients had received immunosuppressants,and 16(88.9%)patients had received biologics.The clinical remission was observed in 72.2%(13/18)patients while 77.8%(14/18)had clinical response at 8th week after first use of UST.The clinical remission was observed in 88.9%(16/18)patients while 94.4%(17/18)had clinical response at 16th/20th week.Endoscopic remission rate was 28.6%(4/14)while endoscopic response rate was 78.6%(11/14)at 16th/20th week.The level of BMI[(21.0±0.5)kg/m^(2) and(21.7±0.4)kg/m^(2) vs.(19.9±0.6)kg/m^(2),all P<0.05],albumin[(41.7±3.7)g/L and(41.7±3.7)g/L vs.(39.6±4.6)g/L,all P<0.05],and hemoglobin[(134.9±12.0)g/L and(135.9±12.3)g/L vs.(126.7±15.8)g/L,all P<0.05]at 8th week and at 16th/20th week were increased significantly than those at 0 week.And the CRP at 8th week and at 16th/20th week were significantly lower than that at 0 week[10.2(5.1,17.5)mg/L and 7.6(3.2,14.7)mg/L vs.15.5(12.3,31.4)mg/L,all P<0.05].However,compared with the baseline value at 0 week,there were no significant difference in ESR and IBDQ score at 8th,16th/20th weeks(all P>0.05).Conclusion UST can effectively improve clinical symptoms and ameliorate endoscopic manifestations of intractable CD patients in the short term.
作者
姚嘉茵
宋孝美
余乔
陈焰
郭红
郅敏
张敏
Yao Jiayin;Song Xiaomei;Yu Qiao;Chen Yan;Guo Hong;Zhi Min;Zhang Min(Department of Gastroenterology,The Sixth Affiliated Hospital,Sun Yat-sen University,Guangzhou 510655,China;Department of Gastroenterology,Xinqiao Hospital,Army Medical University,Chongqing 400037,China;Department of Gastroenterology,The Second Affiliated Hospital,Zhejiang University School of Medicine,Hangzhou 310009,China)
出处
《中华炎性肠病杂志（中英文）》
2021年第2期151-155,共5页
Chinese Journal of Inflammatory Bowel Diseases
基金
国家自然科学基金(81900490)。
