他克莫司治疗难治性克罗恩病的短期疗效分析  

Analysis of the short-term efficacy of tacrolimus in the treatment of refractory Crohn′s disease

作　　者：徐锡涛[1] 吴碧玉 戴张晗[1] 朱明明[1] 王天蓉[1] 童锦禄[1] 冉志华[1] Xu Xitao;Wu Biyu;Dai Zhanghan;Zhu Mingming;Wang Tianrong;Tong Jinlu;Ran Zhihua(Department of Gastroenterology,Shanghai Institute of Digestive Disease,Shanghai Inflammatory Bowel Disease Research Center,Renji Hospital,Shanghai Jiaotong University School of Medicine,Shanghai 200127,China)

机构地区：[1]上海交通大学医学院附属仁济医院消化内科,上海市消化疾病研究所,上海市炎症性肠病研究中心,上海200127

出　　处：《中华炎性肠病杂志（中英文）》2022年第2期115-121,共7页Chinese Journal of Inflammatory Bowel Diseases

摘　　要：目的评估他克莫司治疗难治性克罗恩病(CD)的短期疗效和安全性, 分析临床应答的影响因素。方法采用单中心回顾性队列研究方法, 收集2014年3月至2019年6月上海交通大学医学院附属仁济医院收治的难治性CD患者的临床资料, 均采用他克莫司治疗≥3个月。采用克罗恩病疾病活动指数(CDAI)评估患者的临床应答、临床缓解及复发情况。根据他克莫司治疗3个月的临床应答情况, 将患者分为临床应答组和无临床应答组。采用单因素分析比较2组临床资料的差异, 对单因素分析中P<0.1且有临床意义的变量, 进一步行多因素Logistic回归分析, 明确他克莫司临床应答的独立危险因素。通过受试者工作特征(ROC)曲线分析危险因素预测他克莫司治疗难治性CD患者临床应答的价值。结果共纳入45例难治性CD患者, 其中男性31例, 女性14例;诊断年龄32(27, 39)岁;病程61.0(28.0, 97.5)个月;他克莫司治疗前CDAI评分为203(175, 229)分。45例患者应用他克莫司治疗3个月后, CDAI评分137(117, 175)分, 较治疗前差异具有统计学意义(Z = -5.512, P<0.01);其中临床应答组13例(28.9%), 无临床应答组32例(71.1%)。单因素分析结果, 2组间性别、治疗前CDAI评分、中性粒细胞与淋巴细胞比值(NLR)差异均具有统计学意义(均P<0.05)。将性别、治疗前CDAI评分、NLR进一步行多因素Logistic回归分析, 结果表明CDAI评分(OR = 1.026, 95%CI:1.006 ~ 1.046, P = 0.012)、NLR(OR = 2.605, 95%CI:1.290 ~ 5.258, P = 0.008)是预测他克莫司临床应答的独立危险因素。CDAI评分、NLR、NLR联合CDAI评分预测他克莫司治疗难治性CD患者临床应答的ROC曲线下面积(AUC)分别为0.786(95%CI:0.648 ~ 0.924)、0.764(95%CI:0.595 ~ 0.934)、0.861(95%CI:0.729 ~ 0.992), 最佳截断值分别为189.15、2.82、0.31, 灵敏度分别为100%、84.6%、84.6%, 特异度分别为53.1%、71.9%、84.4%。持续用药的26例患者在应用他克莫司治疗12个月�Objective To assess the short-term efficacy and safety of tacrolimus in patients with refractory Crohn′s disease(CD),and analyze the influencing factors of clinical response.Methods A single center restrospective cohort study was conducted.The clinical data of patients with refractory CD in Renji Hospital of Shanghai Jiaotong University School of Medicine from March 2014 to June 2019 were analyzed retrospectively.The patients received tacrolimus treatment for at least 3 months.Clinical response,clinical remission and relapse after tacrolimus treatment were evaluated by Crohn′s disease activity index(CDAI).According to the existence of clinical response after 3 months of tacrolimus treatment,the patients were divided into clinical response group and non-clinical response group.The differences in clinical data between the 2 groups were assessed by univariate analysis.The variables with P<0.1 in univariate analysis and having clinical significance were further analyzed by multivariate Logistic regression to determine the independent risk factors of clinical response.The receiver operating characteristic(ROC)curve analysis was performed to evaluate the value of risk factors in predicting the clinical response of tacrolimus for the treatment of refractory CD.Results A total of 45 patients with refractory CD were included,including 31 males and 14 females with the age of 32(27,39)years old.The disease duration was 61.0(28.0,97.5)months.The CDAI was 203(175,229)points before the treatment of tacrolimus while it decreased to 137(117,175)points after the treatment of tacrolimus for 3 months,and the difference was significant(Z=-5.512,P<0.01).After the treatment of tacrolimus for 3 months,13 patients(28.9%)with clinical response were set as clinical response group and 32(71.1%)without clinical response were set as non-clinical response group.Univariate analysis showed that the differences in gender,CDAI before the treatment of tacrolimus and neutrophil-to-lymphocyte ratio(NLR)between the clinical response group and non

关 键 词：克罗恩病 难治性 他克莫司 临床应答 临床缓解 危险因素 克罗恩病疾病活动指数 中性粒细胞与淋巴细胞比值 不良反应 

分 类 号：R574[医药卫生—消化系统]