英夫利西单抗对克罗恩病的疗效和安全性的临床研究

Clinical Study of Infliximab for Crohn's Disease on the Efficacy and Safety

目的探讨英夫利西单抗对克罗恩病的疗效和安全性。方法回顾性分析2013年5月至2015年3月于福建医科大学附属第一医院使用英夫利西治疗13例克罗恩病患者的临床和内镜资料,观察治疗第14周、随访终点的BEST-CDAI评分、CRP、ESR、ALB、SES-CD评分,并记录不良反应。结果研究对象男7例,女6例,平均年龄(26.46±12.45)岁,中位病程2.5年;治疗第14周,13例患者的CDAI评分、CRP、ESR均下降,ALB升高,差异有统计学意义(P<0.05),所有患者获得临床缓解(100%);随访终点,13例患者的CDAI评分下降,ALB升高,差异有统计学意义(P<0.05),维持缓解率达90%。8例患者IFX治疗后复查肠镜,5例(62.5%)患者SES-CD下降≥1分,其中2例(25%)达到黏膜完全愈合。不良反应发生率约3.3%,主要包括过敏和感染。结论 IFX对克罗恩病患者的治疗是有效、安全的。

Objective To analyze efficacy and safety of Infliximab（IFX） on Crohn＇s disease（CD）. Methods From May 2013 to March 2015, the clinical and endoscopic data of 13 CD patients with IFX treatment in the first affiliated hospital of Fujian medical university were retrospectively analyzed. Crohn＇s disease active index（CDAI）, C reactive protein（CRP）, erythrocyte sedimentation rate（ESR）, albumin（ALB） and simple endoscopic score for Crohn＇s disease（SESCD） were investigated at week 14 th after IFX injection and the end of follow-up of this study. Adverse reaction was evaluated. Results Thirteen patients（7 male, 6 female） with the average age of（26.46±12.45） years and the mean disease course of 2.5 years were included in the analysis. At week 14 th, the levels of the scores of CDAI, CRP and ESR all decreased significantly, and the level of ALB increased significantly compared with the before the treatment（P〈 0.05）. All patients achieved clinical remission and the remission rate was 100%. By the end of follow-up, the level of the scores of CDAI decreased significantly and the level of ALB increased significantly（P 〈0.05）. The rate of maintain remission was 90%. Eight patients were reviewed by colonoscopic examination after IFX treatment. Five patients（62.5%） decreased the scores of SES-CD and two patients（25%） attained mucosal healing. The rate of adverse events was about 3.3%, including hypersensitirity reaction and infective. Conclusion IFX has good curative effects and safety in the treatment of CD.