英夫利昔单抗治疗儿童克罗恩病的效果分析
영부리석단항치료인동극라은병적효과분석
Efficacy of infliximab in treatment of pediatric Crohn's disease in China
  • 万方数据
    中华儿科杂志 중화인과잡지
    Chinese Journal of Pediatrics
    2014年 9期 688-692 ,共5页

    罗优优%余金丹%赵泓%彭克荣%楼金玕%马鸣%陈洁

    라우우%여금단%조홍%팽극영%루금간%마명%진길

    Crohn病%缓解诱导%激素类%疗效比较研究 Crohn病%緩解誘導%激素類%療效比較研究
    Crohn병%완해유도%격소류%료효비교연구
    Crohn disease%Remission induction%Hormones%Comparative effectiveness research
    目的 观察英夫利昔单抗对儿童克罗恩病的疗效,探讨英夫利昔单抗相对于激素及免疫抑制是否存在治疗优势.方法 将2009年6月至2013年12月浙江大学医学院附属儿童医院收治的＜18岁克罗恩病患儿作为研究对象.纳入标准为:儿童克罗恩病活动指数(PCDAI)＞10;英夫利昔单抗或激素诱导缓解治疗;英夫利昔单抗、免疫抑制剂或美沙拉嗪维持治疗;激素诱导缓解患儿需随访1年以上.将所有患儿分为英夫利昔单抗组和激素组,在治疗后2、4、8、12、24及48周记录相关临床资料、实验室检查及药物不良反应,计算PCDAI、克罗恩病内镜下活动指数(CDEIS).评估患儿的临床应答、临床缓解、复发、黏膜愈合程度及生长发育情况.结果 纳入完整病例22例,其中英夫利昔单抗组和激素组各11例.英夫利昔单抗组在第2、4、8周临床缓解分别为6、5、7例;激素组分别为6、9、9例;两组比较差异均无统计学意义(x2 =0.00、3.14、0.92,P均＞0.05).英夫利昔单抗组在第2、4、8周的临床应答例数分别为8、8、11例;激素组分别为8、9、9例;两组比较差异均无统计学意义(x2 =0.00、0.26、2.20,P均＞0.05).英夫利昔单抗组及激素组患儿PCDAI在第2、4、8周均明显低于第0周(P均＜0.05).在第2、4、8周,两组PCDAI值比较差异均无统计学意义(P均＞0.05).英夫利昔单抗组第12、24、48周的维持缓解比例分别为8/11、7/8、3/5;激素组分别为7/11、9/11、8/11;两组比较差异均无统计学意义(P均＞0.05).在治疗第8周,英夫利昔单抗组及激素组分别中有7例和9例患儿成功诱导缓解.在第12、24、48周两组复发率差异均无统计学意义(x2=0.83、0.09、1.00,P均＞0.05).在第24周,英夫利昔单抗组年龄别身高(HFA)Z评分变化值较激素组显著增高(P＜0.05).其他观察点,两组HFA Z评分的变化值比较及体质指数(BMI)Z评分的变化值比较差异均无统计学意义(P均＞0.05).英夫利昔单抗组中有3例患儿出现不良反应;激素组中所有患儿均出现满月脸等不良反应.结论 英夫利昔单抗对儿童克罗恩病的诱导缓解率与激素类似.英夫利昔单抗治疗不良反应较激素及免疫抑制剂治疗少.
    목적 관찰영부리석단항대인동극라은병적료효,탐토영부리석단항상대우격소급면역억제시부존재치료우세.방법 장2009년6월지2013년12월절강대학의학원부속인동의원수치적＜18세극라은병환인작위연구대상.납입표준위:인동극라은병활동지수(PCDAI)＞10;영부리석단항혹격소유도완해치료;영부리석단항、면역억제제혹미사랍진유지치료;격소유도완해환인수수방1년이상.장소유환인분위영부리석단항조화격소조,재치료후2、4、8、12、24급48주기록상관림상자료、실험실검사급약물불량반응,계산PCDAI、극라은병내경하활동지수(CDEIS).평고환인적림상응답、림상완해、복발、점막유합정도급생장발육정황.결과 납입완정병례22례,기중영부리석단항조화격소조각11례.영부리석단항조재제2、4、8주림상완해분별위6、5、7례;격소조분별위6、9、9례;량조비교차이균무통계학의의(x2 =0.00、3.14、0.92,P균＞0.05).영부리석단항조재제2、4、8주적림상응답례수분별위8、8、11례;격소조분별위8、9、9례;량조비교차이균무통계학의의(x2 =0.00、0.26、2.20,P균＞0.05).영부리석단항조급격소조환인PCDAI재제2、4、8주균명현저우제0주(P균＜0.05).재제2、4、8주,량조PCDAI치비교차이균무통계학의의(P균＞0.05).영부리석단항조제12、24、48주적유지완해비례분별위8/11、7/8、3/5;격소조분별위7/11、9/11、8/11;량조비교차이균무통계학의의(P균＞0.05).재치료제8주,영부리석단항조급격소조분별중유7례화9례환인성공유도완해.재제12、24、48주량조복발솔차이균무통계학의의(x2=0.83、0.09、1.00,P균＞0.05).재제24주,영부리석단항조년령별신고(HFA)Z평분변화치교격소조현저증고(P＜0.05).기타관찰점,량조HFA Z평분적변화치비교급체질지수(BMI)Z평분적변화치비교차이균무통계학의의(P균＞0.05).영부리석단항조중유3례환인출현불량반응;격소조중소유환인균출현만월검등불량반응.결론 영부리석단항대인동극라은병적유도완해솔여격소유사.영부리석단항치료불량반응교격소급면역억제제치료소.
    Objective To investigate the efficacy of infliximab versus corticosteroids in achieving clinical remission in pediatric patients with Crohn's disease in China.Method 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.Inclusion criteria: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.Result 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 (x2 =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 (x2 =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 (x2 =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.Conclusion 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.
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