英夫利西单克隆抗体治疗克罗恩病疗效与抗核抗体的相关性分析

Analysis on correlation between antinuclear antibodies and the efficacy of infliximab in Crohn's disease patients

目的探讨克罗恩病(CD)患者英夫利西单克隆抗体(IFX)治疗后抗核抗体(ANA)形成与临床应答的相关性。方法采用回顾性病例对照的研究方法,收集2018年1月至2021年9月于南京大学医学院附属鼓楼医院消化科首次接受IFX治疗的CD患者的临床资料。采用相关性分析探究ANA形成与临床应答是否存在相关性。根据治疗25周后ANA的检测结果,分为阴性组和阳性组,采用单因素分析比较两组临床资料的差异,对单因素分析中P<0.15且有临床意义的变量,纳入多因素Logistic回归分析,分析ANA诱导形成的独立危险因素。结果共纳入82例CD患者,41例(50.0%)为阳性组,41例(50.0%)为阴性组。从临床应答情况来看,两组临床应答率分别为68.3%、41.5%,差异有统计学意义(χ^(2)=5.959,P=0.015)。根据ANA滴度高低将阳性组分为1∶100组17例、1∶320组11例和≥1∶1000组13例,3组的临床应答率分别为41.5%、45.5%、7.7%,差异无统计学意义(χ^(2)=5.334,P=0.084)。从不良事件发生情况来看,阳性组和阴性组分别为17.1%、7.3%,差异无统计学意义(χ^(2)=1.822,P=0.177)。单因素分析发现两组治疗前总蛋白差异有统计学意义(P<0.05)。Logistic回归分析发现首次用药年龄(OR=1.060,95%CI:1.015~1.107,P=0.008)和基线总蛋白水平(OR=1.110,95%CI:1.023~1.205,P=0.012)是CD患者IFX治疗后ANA诱导形成的独立危险因素。结论IFX治疗后ANA的诱导形成可在一定程度上影响IFX的临床应答,治疗期间需定期监测ANA滴度。此外,首次用药年龄、基线总蛋白水平可能与治疗后ANA的产生有关。

Objective To investigate the correlation of antinuclear antibody(ANA)with clinical response to infliximab(IFX)in patients with Crohn's disease(CD).Methods Patients who were diagnosed as CD and treated with IFX in Nanjing Drum Tower Hospital from January 2018 to September 2021 were retrospectively studied.The correlation analysis was used to explore the correlation between ANA and clinical response.These patients were divided into two groups according to the ANA titer after 25 weeks of IFX treatment.The differences in clinical data between the two groups were assessed by univariate analysis.The variables with P<0.15 in univariate analysis and having clinical significance were further analyzed by multivariate Logistic regression to determine the independent risk factors of the induction of ANA.Results A total of 82 patients with CD were included.Forty-one(50.0%)patients were set as positive group,and 41(50.0%)patients were set as negative group.In terms of clinical response,the clinical response rates of two groups were 68.3% and 41.5%,and the difference was significant(χ^(2)=5.959,P=0.015).Positive group was divided into 1∶100 subgroup(n=17),1∶320 subgroup(n=11)and≥1∶1000 subgroup(n=13).The clinical response rates of three groups were 41.2%,45.5%and 7.7%respectively,and the difference was not statistically significant(χ^(2)=5.334,P=0.084).The incidences of adverse events in the two groups were 17.1% and 7.3%,and the difference was not significant(χ^(2)=1.822,P=0.177).Univariate analysis showed that the difference of total protein(TP)before IFX treatment between the positive group and negative group was statistically significant(P<0.05).Multivariate logistic regression analysis showed that age(OR=1.060,95%CI:1.015~1.107,P=0.008)and the baseline TP(OR=1.110,95%CI:1.023~1.205,P=0.012)were the independent risk factors for the induction of ANA.Conclusions The formation of ANA may affect the clinical response of IFX,so the ANA titer should be monitored regularly during the IFX therapy.In addition,age and baseline TP are related to the formation of ANA.