英夫利西单抗治疗儿童溃疡性结肠炎的疗效及安全性

Efficacy and safety of infliximab in the treatmentof ulcerative colitis in children

目的评价英夫利西单抗(IFX)治疗儿童溃疡性结肠炎(UC)的疗效以及安全性。方法回顾性分析2018年1月至2022年12月在济南市儿童医院接受IFX治疗的21例溃疡性结肠炎患儿临床资料。比较治疗前后儿童UC疾病活动指数(PUCAI)、内镜严重程度评分和实验室检查结果,评估IFX疗效及安全性。结果21例UC患儿中男12例、女9例。IFX疗效分析显示,第14周诱导缓解期临床应答率76.2%(16/21),临床缓解率66.7%(14/21)。第30周维持缓解期临床应答率76.4%(13/17),持续缓解率58.5%(10/17)。与治疗前相比,IFX治疗第14周及30周PUCAI、C反应蛋白(CRP)、红细胞沉降率(ESR)、粪便钙卫蛋白均明显下降(P<0.05),血红蛋白、白蛋白均有显著改善(P<0.05)。14周复查结肠镜,8例达到黏膜愈合,6例由重度炎症减轻为中度炎症,4例黏膜炎症中度炎症减轻为轻度炎症,2例黏膜炎症无好转。IFX输液反应发生率为43%(9/21),包括急性输液反应、迟发性输液反应、转氨酶升高,其中治疗期间感染最常见,发生率为38%(8/21)。结论IFX对儿童UC疗效显著,但治疗期间需警惕不良事件的发生。

Objective To evaluate the efficacy and safety of infliximab(IFX)in children with ulcerative colitis(UC).Methods The clinical data of 21 children with ulcerative colitis who received IFX at Jinan Children′s Hospital from January 2018 to December 2022 were analyzed retrospectively.The pediatric ulcerative colitis activity index(PUCAI),ulcerative colitis endoscopic index of severity and laboratory findings were compared to assess the efficacy and safety of IFX.Results There were 12 males and 9 females among 21 children with UC.IFX efficacy analysis showed that the clinical response rate at week 14 was 76.2%(16/21)and the clinical response rate was 66.7%(14/21).The clinical response rate in maintained remission at week 30 was 76.4%(13/17)and the sustained response rate was 58.5%(10/17).PUCAI score,C reactive protein,erythrocyte sedimentation rate and fecal calprotectin were significantly decreased in 14 and 30 weeks of IFX treatment compared with before treatment(P<0.05),and hemoglobin and albumin were significantly improved(P<0.05).At 14 weeks,8 cases achieved mucosal healing,6 cases reduced severe mucosal inflammation to moderate inflammation,4 cases reduced moderate inflammation to mild inflammation,and 2 cases showed no improvement in mucosal inflammation.The incidence of IFX infusion reactions was 43%(9/21),including acute infusion reactions,delayed infusion reactions,and transaminase elevation.Infections were the most common during treatment,with an incidence of 38%(8/21).Conclusion IFX is effective on UC in children,However,we should be alert to the occurrence of adverse events during the treatment.