英夫利西单克隆抗体治疗儿童溃疡性结肠炎的疗效及安全性评价

Efficacy and safety of infliximab in pediatric ulcerative colitis

目的评价英夫利西单克隆抗体(IFX)治疗儿童溃疡性结肠炎(UC)的疗效和安全性。方法回顾性分析2017年1月至2021年12月首都医科大学附属北京儿童医院诊治的17例应用IFX治疗的UC患儿的临床资料, 比较治疗前后儿童UC活动指数(PUCAI)和实验室数据, 评估IFX疗效及安全性。结果共纳入17例UC患儿, 男9例, 女8例, 中位起病年龄12.1(10.7, 12.8)岁, 首次应用IFX的中位年龄12.5(11.8, 13.6)岁, IFX用药持续时间46.1(17.4, 56.9)周, IFX中位注射次数为8.0(4.5, 10.5)次。17例UC患儿IFX治疗前PUCAI评分平均值为(50.6±21.2)分, Mayo内镜评分:重度炎症10例, 中度炎症6例, 轻度炎症1例。IFX疗效分析:第14周诱导缓解期应答率87.5%(14/16), 临床缓解率56.3%(9/16)。第30周维持缓解期持续应答率81.8%(9/11), 持续缓解率36.4%(4/11)。IFX治疗第14周与治疗前相比, PUCAI评分[2.5(0, 10.0)分比50.0(41.3, 70.0)分]和白细胞计数[5.7(4.8, 8.6)×10^(9)/L比8.7(6.4, 13.5)×10^(9)/L]均明显下降(均P<0.05), 血红蛋白[(113.8±20.4) g/L比(99.3±19.4) g/L]和白蛋白水平[42.2(40.0, 44.4) g/L比36.6(28.6, 40.2) g/L]均明显升高, 差异有统计学意义(均P<0.05)。12例活动期UC患儿IFX治疗14周复查结肠镜, 仅2例达到黏膜愈合, 5例由治疗前黏膜重度炎症减轻为中度炎症, 5例黏膜炎症无好转。7例患儿发生10例次不良反应, 2例发生4例次急性输液反应, 5例发生6例次感染。结论 IFX在儿童UC患者的诱导和维持临床缓解方面具有较好的疗效, 且相对安全。

Objective To evaluate the efficacy and safety of infliximab(IFX)in pediatric patients with ulcerative colitis(UC).Methods The clinical data of 17 UC patients who received IFX treatment at Beijing Children′s Hospital,Capital Medical University from January 2017 to December 2021 were retrospectively analyzed,and the pediatric ulcerative colitis activity index(PUCAI)and laboratory data were compared before and after treatment to evaluate the efficacy and safety of IFX.Results A total of 17 UC patients were included,and among them there were 9 boys and 8 girls.The age of onset was 12.1(10.7,12.8)years old,and median age at IFX initiation was 12.5(11.8,13.6)years old.The duration of IFX medication was 46.1(17.4,56.9)weeks,and the times of IFX injections was 8.0(4.5,10.5).The mean PUCAI score of the 17 UC patients at start of IFX treatment was(50.6±21.2)points,and the Mayo endoscopic score showed:ten severe activity,six moderate activity,and one mild activity.IFX efficacy analysis:the clinical response rate was 87.5%(14/16),and the clinical remission rate was 56.3%(9/16)at the 14th week.The sustained response rate was 81.8%(9/11),and the sustained remission rate was 36.4%(4/11)at the 30th week.At the 14th week of IFX treatment,PUCAI score[2.5(0,10.0)points vs.50.0(41.3,70.0)points]and white blood cell count[5.7(4.8,8.6)×10^(9)/L vs.8.7(6.4,13.5)×10^(9)/L]significantly decreased(all P<0.05),hemoglobin[(113.8±20.4)g/L vs.(99.3±19.4)g/L]and albumin level[42.2(40.0,44.4)g/L vs.36.6(28.6,40.2)g/L]significantly increased compared with those before IFX treatment,and the differences were statistically significant(all P<0.05).The Mayo endoscopic scores at 14 weeks of IFX treatment in 12 active UC patients showed:only 2 patients achieved mucosal healing,5 patients had reduced from severe to moderate mucosal inflammation,and 5 patients had no improvement.Seven patients had 10 adverse events,2 cases had 4 times acute infusion reactions,and 5 cases had 6 times infections.Conclusion IFX is effective and relatively safe in inducing and maintaining clinical remission in pediatric UC patients.