Luo Youyou, Yu Jindan, Zhao Hong, Peng Kerong, Lou Jingan, Ma Ming, Chen Jie
Department of Gastroenterology, the Children's Hospital, Zhejiang University, School of Medicine, Hangzhou 310003, China.
Department of Gastroenterology, the Children's Hospital, Zhejiang University, School of Medicine, Hangzhou 310003, China. Email:
Zhonghua Er Ke Za Zhi. 2014 Sep;52(9):688-92.
To investigate the efficacy of infliximab versus corticosteroids in achieving clinical remission in pediatric patients with Crohn's disease in China.
Data of all newly diagnosed active Crohn's disease pediatric cases seen from June 2009 to December 2013 in Children's Hospital, Zhejiang University School of Medicine were retrospectively recorded and reviewed.
the age of the children was less than 18 years; pediatric Crohn's disease activity index (PCDAI) was more than 10; infliximab or corticosteroids were used for inducing remission; infliximab, immunosuppressive medications or mesalamine was prescribed for maintaining remission. Patients in steroids group were followed up for more than 1 year. The enrolled patients were divided into two groups: infliximab group and steroids group. Clinical data, laboratory findings and side effects of the medications were collected at week 2, 4, 12, 24 and 48. PCDAI and Crohn's disease endoscopic index score (CDEIS) were calculated. Clinical response rate, clinical remission rate, relapse rate, mucosal healing and growth were evaluated.
Eleven children received infliximab therapy and 11 subjects received corticosteroids. In Infliximab group, 6, 5 and 7 patients were in clinical remission at week 2, 4, and 8, while so were 6, 9, and 9 patients in steroids group. The difference was not statistically significant (χ² = 0.00, 3.14, 0.92, P > 0.05). In infliximab group, 8, 8, and 11 patients were in clinical remission at week 2, 4, and 8, so were 8, 9, and 9 patients in steroids group. The difference was not statistically significant (χ² = 0.00,0.26, 2.20, P > 0.05). When compared with data at baseline, significant decreases were observed in the median PCDAI between the two groups at week 2, 4, and 8 (all P < 0.05). But there were no significant differences between two groups at week 2, 4, and 8 (all P > 0.05). At week 12, 24 and 48, 8/11, 7/8, 3/5 cases on infliximab versus 7/11, 9/11, 8/11 cases on steroids maintained remission. There was no significant differences between the two groups (all P > 0.05). In 7 patients and 9 patients remission was successfully induced at week 8. The relapse rate was similar at week 12, 24, and 48 (χ² = 0.83, 0.09, 1.00, all P > 0.05). Height for age Z score in infliximab group was significantly higher than that in steroids group at week 24 (P < 0.05). Body mass index Z score between the two groups at week 8, 24, and 48 were not statistically significant (all P > 0.05). Of the children treated with infliximab, 3 developed side effects. All the children treated with steroids got Cushing's syndrome.
In children with Crohn's disease, infliximab therapy is as effective as corticosteroids to induce remission.Less side effects were observed with infliximab therapy compared with immunosuppressive medication and mesalamine.
探讨英夫利昔单抗与皮质类固醇激素对中国克罗恩病患儿实现临床缓解的疗效。
回顾性记录并分析2009年6月至2013年12月在浙江大学医学院附属儿童医院新诊断的所有活动性克罗恩病患儿的数据。
年龄小于18岁;儿童克罗恩病活动指数(PCDAI)大于10;使用英夫利昔单抗或皮质类固醇激素诱导缓解;使用英夫利昔单抗、免疫抑制药物或美沙拉嗪维持缓解。激素组患者随访1年以上。将入选患者分为两组:英夫利昔单抗组和激素组。在第2、4、12、24和48周收集临床数据、实验室检查结果及药物副作用。计算PCDAI和克罗恩病内镜指数评分(CDEIS)。评估临床缓解率、临床应答率、复发率、黏膜愈合及生长情况。
11例患儿接受英夫利昔单抗治疗,11例接受皮质类固醇激素治疗。英夫利昔单抗组在第2、4和8周时分别有6例、5例和7例达到临床缓解,激素组分别有6例、9例和9例,差异无统计学意义(χ² = 0.00、3.14、0.92,P > 0.05)。英夫利昔单抗组在第2、4和8周时分别有8例、8例和11例达到临床缓解,激素组分别有8例、9例和9例,差异无统计学意义(χ² = 0.00、0.26、2.20,P > 0.05)。与基线数据相比,两组在第2、4和8周时PCDAI中位数均显著下降(均P < 0.05),但两组间差异无统计学意义(均P > 0.05)。在第12、24和48周时,英夫利昔单抗组分别有8/11、7/8、3/5例维持缓解,激素组分别有7/11、9/11、8/11例,两组间差异无统计学意义(均P > 0.05)。第8周时,英夫利昔单抗组7例和激素组9例成功诱导缓解。第12、24和48周时复发率相似(χ² = 0.83、0.09、1.00,均P > 0.05)。第24周时,英夫利昔单抗组年龄别身高Z评分显著高于激素组(P < 0.05)。第8、24和48周时两组间体重指数Z评分差异无统计学意义(均P > 0.