Analysis of the short-term efficacy of tacrolimus in the treatment of refractory Crohn′s disease
10.3760/cma.j.cn101480-20220302-00033
- VernacularTitle:他克莫司治疗难治性克罗恩病的短期疗效分析
- Author:
Xitao XU
1
;
Biyu WU
1
;
Zhanghan DAI
1
;
Mingming ZHU
1
;
Tianrong WANG
1
;
Jinlu TONG
1
;
Zhihua RAN
1
Author Information
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
- Publication Type:Journal Article
- Keywords:
Crohn′s disease, refractory;
Tacrolimus;
Clinical response;
Clinical remission;
Risk factors;
Crohn′s disease activity index;
Neutrophil-to-lymphocyte ratio
- From:
Chinese Journal of Inflammatory Bowel Diseases
2022;06(2):115-121
- CountryChina
- Language:Chinese
-
Abstract:
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-clinical response group were statistically significant (all P<0.05) . Gender, CDAI before the treatment of tacrolimus and NLR were included for the multivariate Logistic regression analysis. The results showed that CDAI ( OR = 1.026, 95% CI: 1.006-1.046, P = 0.012) and NLR ( OR = 2.605, 95% CI: 1.290-5.258, P = 0.008) were the independent risk factors for predicting clinical response. The areas under ROC curve of CDAI, NLR and NLR combined with CDAI in predicting clinical response of tacrolimus in patients with refractory CD were 0.786 (95% CI : 0.648-0.924) , 0.764 (95% CI: 0.595-0.934) and 0.861 (95% CI : 0.729-0.992) , the optimal cut-off values were 189.15, 2.82 and 0.31, sensitivities were 100%, 84.6% and 84.6%, and specificities were 53.1%, 71.9% and 84.4%, respectively. Twenty-six patients continued to receive tacrolimus for 12 months, and the clinical remission rate was 73.1% (19/26) and the recurrence rate was 26.9% (7/26) . Forty-five patients were followed up for 1 year, adverse effects occurred in 6 and there was no severe adverse effects during the treatment of tacrolimus. Conclusions:Tacrolimus can be used as an immunosuppressant to induce the remission and maintenance in refractory CD patients. CDAI and NLR can be used as independent indicators to predict the clinical response of tacrolimus in the treatment of patients with refractory CD, and the combination of CDAI and NLR has higher prediction efficiency.
