中华消化杂志
中華消化雜誌
중화소화잡지
Chinese Journal of Digestion
2013年
12期
835-839
,共5页
Crohn病%抗体,单克隆%直肠瘘%肠黏膜
Crohn病%抗體,單剋隆%直腸瘺%腸黏膜
Crohn병%항체,단극륭%직장루%장점막
Crohn disease%Antibodies,monoclonal%Rectal fistula%Intestinal mucosa
目的 评价英夫利西治疗CD患者的疗效及安全性.方法 回顾性分析2009年2月至2013年3月使用英夫利西治疗的62例CD患者的临床资料,选取英夫利西治疗后第14周(英夫利西注射3次后)和本研究随访终点(2013年3月)2个观察点.观察英夫利西治疗后第14周的CRP水平、克罗恩病活动指数(CDAI)评分情况及临床缓解情况.在随访终点,观察英夫利西治疗后的临床缓解情况、肛瘘闭合情况、结肠黏膜愈合情况及不良反应.正态分布数据用x±s表示,t检验比较治疗前后差异.非正态分布数据用中位数(下四分位数,上四分位数)表示,Wilcoxon非参数检验比较治疗前后差异.结果 剔除4例注射未满3次的患者、1例失访的患者、9例术后预防复发的患者,共有48例处于活动期的CD患者纳入疗效研究.第14周时,48例患者的CRP为1.9 (0.5,5.4) mg/L,与治疗前的28.9 (6.4,51.1)mg/L相比下降(Z=一5.468,P＜0.01);CDAI评分为87.0±35.8,与治疗前(245.1±59.1)相比显著下降(t=18.579,P＜0.01).第14周时,46例CD活动患者达到临床缓解,缓解率为95.8％oo.随访终点时,仍有38例患者维持临床缓解,缓解率为79.2％.有26例患者在英夫利西治疗前有活动性肛瘘,7例(26.9％)肛瘘完全闭合,17例(65.4％)部分闭合,2例(7.7％)无反应.15例患者在英夫利西治疗≥6次后肠镜复查,治疗后简化CD内镜评分(SES-CD)为3(0,5),较治疗前[8(7,9)]下降(Z=-3.306,P=0.001).48例CD活动患者中22例采用上阶梯治疗,26例采用下阶梯治疗.第14周时,上阶梯治疗组有20例(90.9％)、下阶梯治疗组有26例(100.0％)进入临床缓解;随访终点时,上阶梯治疗组有14例(63.6％)、下阶梯治疗组有24例(92.3％)维持临床缓解.26例肛瘘患者中2例无反应者均为上阶梯治疗组,完全闭合者7例均为下阶梯治疗组.62例患者中有5例发生不良反应,其中3例为急性输液反应,1例为迟发性输液反应,1例发生贫血.结论 英夫利西在控制CD患者炎性反应活动、诱导临床缓解、促进肛瘘闭合及黏膜愈合方面体现出较好的疗效.对部分高危CD患者使用下阶梯治疗也显现了较好的疗效.
目的 評價英伕利西治療CD患者的療效及安全性.方法 迴顧性分析2009年2月至2013年3月使用英伕利西治療的62例CD患者的臨床資料,選取英伕利西治療後第14週(英伕利西註射3次後)和本研究隨訪終點(2013年3月)2箇觀察點.觀察英伕利西治療後第14週的CRP水平、剋囉恩病活動指數(CDAI)評分情況及臨床緩解情況.在隨訪終點,觀察英伕利西治療後的臨床緩解情況、肛瘺閉閤情況、結腸黏膜愈閤情況及不良反應.正態分佈數據用x±s錶示,t檢驗比較治療前後差異.非正態分佈數據用中位數(下四分位數,上四分位數)錶示,Wilcoxon非參數檢驗比較治療前後差異.結果 剔除4例註射未滿3次的患者、1例失訪的患者、9例術後預防複髮的患者,共有48例處于活動期的CD患者納入療效研究.第14週時,48例患者的CRP為1.9 (0.5,5.4) mg/L,與治療前的28.9 (6.4,51.1)mg/L相比下降(Z=一5.468,P＜0.01);CDAI評分為87.0±35.8,與治療前(245.1±59.1)相比顯著下降(t=18.579,P＜0.01).第14週時,46例CD活動患者達到臨床緩解,緩解率為95.8％oo.隨訪終點時,仍有38例患者維持臨床緩解,緩解率為79.2％.有26例患者在英伕利西治療前有活動性肛瘺,7例(26.9％)肛瘺完全閉閤,17例(65.4％)部分閉閤,2例(7.7％)無反應.15例患者在英伕利西治療≥6次後腸鏡複查,治療後簡化CD內鏡評分(SES-CD)為3(0,5),較治療前[8(7,9)]下降(Z=-3.306,P=0.001).48例CD活動患者中22例採用上階梯治療,26例採用下階梯治療.第14週時,上階梯治療組有20例(90.9％)、下階梯治療組有26例(100.0％)進入臨床緩解;隨訪終點時,上階梯治療組有14例(63.6％)、下階梯治療組有24例(92.3％)維持臨床緩解.26例肛瘺患者中2例無反應者均為上階梯治療組,完全閉閤者7例均為下階梯治療組.62例患者中有5例髮生不良反應,其中3例為急性輸液反應,1例為遲髮性輸液反應,1例髮生貧血.結論 英伕利西在控製CD患者炎性反應活動、誘導臨床緩解、促進肛瘺閉閤及黏膜愈閤方麵體現齣較好的療效.對部分高危CD患者使用下階梯治療也顯現瞭較好的療效.
목적 평개영부리서치료CD환자적료효급안전성.방법 회고성분석2009년2월지2013년3월사용영부리서치료적62례CD환자적림상자료,선취영부리서치료후제14주(영부리서주사3차후)화본연구수방종점(2013년3월)2개관찰점.관찰영부리서치료후제14주적CRP수평、극라은병활동지수(CDAI)평분정황급림상완해정황.재수방종점,관찰영부리서치료후적림상완해정황、항루폐합정황、결장점막유합정황급불량반응.정태분포수거용x±s표시,t검험비교치료전후차이.비정태분포수거용중위수(하사분위수,상사분위수)표시,Wilcoxon비삼수검험비교치료전후차이.결과 척제4례주사미만3차적환자、1례실방적환자、9례술후예방복발적환자,공유48례처우활동기적CD환자납입료효연구.제14주시,48례환자적CRP위1.9 (0.5,5.4) mg/L,여치료전적28.9 (6.4,51.1)mg/L상비하강(Z=일5.468,P＜0.01);CDAI평분위87.0±35.8,여치료전(245.1±59.1)상비현저하강(t=18.579,P＜0.01).제14주시,46례CD활동환자체도림상완해,완해솔위95.8％oo.수방종점시,잉유38례환자유지림상완해,완해솔위79.2％.유26례환자재영부리서치료전유활동성항루,7례(26.9％)항루완전폐합,17례(65.4％)부분폐합,2례(7.7％)무반응.15례환자재영부리서치료≥6차후장경복사,치료후간화CD내경평분(SES-CD)위3(0,5),교치료전[8(7,9)]하강(Z=-3.306,P=0.001).48례CD활동환자중22례채용상계제치료,26례채용하계제치료.제14주시,상계제치료조유20례(90.9％)、하계제치료조유26례(100.0％)진입림상완해;수방종점시,상계제치료조유14례(63.6％)、하계제치료조유24례(92.3％)유지림상완해.26례항루환자중2례무반응자균위상계제치료조,완전폐합자7례균위하계제치료조.62례환자중유5례발생불량반응,기중3례위급성수액반응,1례위지발성수액반응,1례발생빈혈.결론 영부리서재공제CD환자염성반응활동、유도림상완해、촉진항루폐합급점막유합방면체현출교호적료효.대부분고위CD환자사용하계제치료야현현료교호적료효.
Objective To evaluate the clinical efficacy and safety of iMliximab (IFX) in the treatment of Crohn's disease (CD).Methods From February 2009 to March 2013,the clinical data of 62 CD patients with IFX treatment were retrospectively analyzed.At week 14th after IFX injection and the end of follow-up of this study (March 2013) were two observation points.At week 14th after IFX injection (three times of IFX injection),C reactive protein (CRP) level,Crohn's disease activity index (CDAI) score and clinical remission were investigated.At the end of follow-up,clinical remission,fistula closure,mucosal healing and side effects were inspected.Normal distribution data were expressed as 2±s,which were compared with t test.Non normal distribution data were expressed as M (QL-QU) and compared with Wilcoxon test.Results Four cases without complete three times of IFX injection and one case lost to follow-up were eliminated.And nine postoperation cases with IFX treatment to prevent recurrence after surgery were excluded.A total of 48 cases of CD in active period were enrolled in this study on efficacy.At week 14th,CRP level of 48 patients [1.9(0.5,5.4) mg/L]decreased compared with that before treatment [28.9(6.4,51.1) mg/L] (Z=-5.468,P＜0.01);CDAI score (87.0±35.8) also decreased compared with that before treatment (245.1±59.1) (t=18.579,P＜0.01).At week 14th,46 patients in active period achieved clinical remission and the remission rate was 95.8％.By the end of follow-up,38 patients were still in remission period and the remission rate was 79.2％.Among 26 patients with anal fistula before IFX treatment,seven cases (26.9％) were completely closed,17 cases (65.4％) was partially closed and two cases was responseless.Fifteen patients were reviewed by colonoscopic examination after more than six times of IFX treatment.The median of simple endoscopic score for Crohn's disease (SES-CD) was 3 (0,5)after treatment,which decreased compared with that before treatment (8(7,9),Z=-3.306,P=0.001).Twenty-two of 48 cases in active period received,step-up strategy and 26 cases received with top-down strategy.At week 14th,20 cases (90.9％) of group with step-up strategy and 26 cases (100.0％) of group with top-down strategy were in remission period.By the end of follow-up,14 cases (63.6％) of group with step-up strategy and 24 cases (92.3％) of group with top down strategy maintained remission.Among 26 cases with anal fistula,two cases without response were treated with step-up strategy and seven cases with complete closure were all with top-down strategy.Among 62 patients,five had side effects,three of whom had acute infusion reaction,one had delayed infusion reaction and the other had anemia.Conclusions IFX had good clinical efficacy in controlling inflammation,inducing clinical remission,promoting fistula closure and mucosal healing in CD patients.For some CD patients with high risk,the initial top-down strategy showed good clinical efficacy.
