英夫利西单抗药物监测对儿童克罗恩病患者54周治疗结局的影响

Effect of Infliximab Drug Monitoring on 54 Weeks Treatment Outcome of Children with Crohn's Disease

关键词:  克罗恩病  儿童  药物浓度监测  英夫利西单抗

Key words:  Crohn's disease  children  therapeutic drug monitoring  infliximab

摘要:

目的 英夫利西单抗药物谷浓度与抗体监测对儿童克罗恩病治疗54周临床结局的影响。方法 回顾分析2017年8月—2023年3月在浙江大学医学院附属儿童医院诊断为克罗恩病的6~17岁患儿的临床资料，根据英夫利西单抗谷浓度及抗体监测方式分为被动监测组和主动监测组，比较2组患儿治疗54周结肠镜下黏膜愈合率、疾病活动度和实验室指标等结局。结果 研究共纳入77例克罗恩病患儿，英夫利西单抗谷浓度及抗体被动监测组34例，主动监测组43例，男性48例，女性29例。治疗54周主动监测组黏膜愈合率较被动监测组高，分别为80%(24/30)和46.43%(13/28)，2组相比差异有统计学意义(P=0.01)。治疗54周2组总的临床缓解率为84.42%(65/77)，被动监测组与主动监测组的临床缓解率分别为76.47%(26/34)和90.70%(39/43)，2组相比差异无统计学意义。实验室指标上，主动监测组超敏C反应蛋白、红细胞沉降率和血清白蛋白水平改善较被动监测组显著。2组患儿抗英夫利西单抗抗体产生率差异无统计学意义。结论 对英夫利西单抗药物谷浓度与抗体进行主动监测与被动监测相比可能提高治疗54周时结肠镜下的黏膜愈合率。

Abstract:

OBJECTIVE To investigate the effect of infliximab through concentration and antibody monitoring on the clinical outcome of children with Crohn's disease after 54 weeks of treatment. METHODS A retrospective analysis was conducted with clinical data of pediatric patients aged 6-17 years who were diagnosed with Crohn's disease at Children's Hospital, Zhejiang University School of Medicine from August 2017 to March 2023. They were divided into a reactive and a proactive monitoring group according to the monitoring method. The mucosal healing rate, disease activity, and laboratory indicators were compared after 54 weeks of treatment. RESULTS There were 77 pediatric patients with Crohn's disease included, with 34 patients from the reactive therapeutic drug monitoring group and 43 from the proactive therapeutic drug monitoring group, including 48 males and 29 females. At 54 weeks, the mucosal healing rate in the proactive therapeutic drug monitoring group was higher than that in the reactive therapeutic drug monitoring group, which was 80%(24/30) and 46.43%(13/28), respectively. The two groups had a statistical difference(P=0.01). The total clinical remission rate at 54 weeks was 84.42%(65/77), while the clinical remission rates at 54 weeks were 76.47%(26/34) in the reactive therapeutic drug monitoring group and 90.70%(39/43) in the proactive therapeutic drug monitoring group, respectively. The two groups had no statistical difference. The improvement of hypersensitive C-reactive protein, erythrocyte sedimentation rate, and serum albumin level in the proactive monitoring group was greater than in the reactive monitoring group. There was no statistical difference in the production rate of antibodies to infliximab between the two groups. CONCLUSION Proactive therapeutic drug monitoring in detecting through concentration of infliximab and antibodies may improve the mucosal healing rate compared with reactive therapeutic drug monitoring after 54 weeks of infliximab treatment.