CAJ | 학술논문

目的评价克罗恩病(CD)患者使用英夫利西(IFX)的疗效及对黏膜愈合和促进瘘管闭合的影响.方法收集2007年9月至2011年2月上海交通大学医学院附属瑞金医院消化科使用IFX治疗的CD患者的临床资料,回顾性分析IFX的疗效和安全性.IFX治疗后疗效评价内容包括实验室指标、临床疗效、瘘管治疗疗效和黏膜修复.统计学处理采用t检验和Wilcoxon符号秩和检验.结果共22例患者纳入本次研究,男11例,女11例,平均29.3岁.予IFX 5～I0 mg/kg剂量在第0、2、6周诱导缓解治疗,随后每隔8周维持治疗.22例患者中,有16例活动性CD,1例中途退出,其余15例在治疗第14周时,11例缓解、2例临床有效、2例无效.14周时克罗恩病活动指数(CDAI)评分(112±80)和ESR[( 13±11)mm/1 h]与0周时的(186±88)、(21±15)mm/1 h相比均下降(Z值分别为-2.712和-2.378,P值分别=0.04和0.007).10例有瘘管的患者中2例无效退出,8例患者的瘘管对IFX部分反应;6例在维持治疗期间持续有反应,但未见瘘管完全闭合消失.7例患者在使用IFX治疗5次(24周)后内镜复查,治疗后简化克罗恩病内镜评分(SES-CD)评分(3.21±2.89)较治疗前(5.86±3.02)下降(Z=-2.38,P＝0.018).9例患者共发生11次不良事件,以输注反应、呼吸道感染多见,无严重不良反应发生.结论 IFX可快速改善患者临床症状,安全性高.而且IFX在黏膜愈合和瘘管治疗方面的作用可在用药早期显现.
목적 평개극라은병(CD)환자사용영부리서(IFX)적료효급대점막유합화촉진루관폐합적영향.방법 수집2007년9월지2011년2월상해교통대학의학원부속서금의원소화과사용IFX치료적CD환자적림상자료,회고성분석IFX적료효화안전성.IFX치료후료효평개내용포괄실험실지표、림상료효、루관치료료효화점막수복.통계학처리채용t검험화Wilcoxon부호질화검험.결과 공22례환자납입본차연구,남11례,녀11례,평균29.3세.여IFX 5～I0 mg/kg제량재제0、2、6주유도완해치료,수후매격8주유지치료.22례환자중,유16례활동성CD,1례중도퇴출,기여15례재치료제14주시,11례완해、2례림상유효、2례무효.14주시극라은병활동지수(CDAI)평분(112±80)화ESR[( 13±11)mm/1 h]여0주시적(186±88)、(21±15)mm/1 h상비균하강(Z치분별위-2.712화-2.378,P치분별=0.04화0.007).10례유루관적환자중2례무효퇴출,8례환자적루관대IFX부분반응;6례재유지치료기간지속유반응,단미견루관완전폐합소실.7례환자재사용IFX치료5차(24주)후내경복사,치료후간화극라은병내경평분(SES-CD)평분(3.21±2.89)교치료전(5.86±3.02)하강(Z=-2.38,P＝0.018).9례환자공발생11차불량사건,이수주반응、호흡도감염다견,무엄중불량반응발생.결론 IFX가쾌속개선환자림상증상,안전성고.이차IFX재점막유합화루관치료방면적작용가재용약조기현현.
Objective To evaluate the clinical efficacy of infliximab (IFX) in Crohn′s disease (CD) and its effects on mucosal healing and promoting fistula closure.Methods Between September 2007 and February 2011,relevant clinical data of CD patients treated with IFX in the Department of Gastroenterology,Ruijin Hospital were collected and the efficacy and safety of IFX were retrospectively analyzed.After IFX therapy,the efficacy evaluation included laboratory index,clinical efficacy,efficacy of fistula closure and mucosal healing.The data were analyzed using t test and Wilcoxon signed-rank test.Results A total of 22 patients were enrolled in this study,11 males and 11 females; the mean age was 29.3 years.The dosage of IFX was 5 mg/kg to 10 mg/kg at week 0,2,6to induce remission,and every 8 weeks on maintenance therapy.Of 22 patients,16 patients were active CD.One case dropped out.At week 14,of the remaining 15 cases,11 cases achieved clinical remission,two cases achieved clinically effective and two cases were ineffective.Crohn′s disease activity index (CDAI) (112±80) and ESR [(13±11) mm/1 h] of week 14 decreased compared with that of week 0 [(186±88),(21± 15) mm/1 h,P=0.04 and 0.007].Two cases of 10 patients with fistula dropped out as a result of ineffective,while eight cases had a partial response and six patients sustained response during the maintenance therapy,but no fistula closed and completely disappear.Seven patients reviewed by endoscopy after five times IFX therapy (24 weeks),after therapy the simple endoscopic score for Crohn′ s disease (SES-CD) ( 3.21 ± 2.89 ) decreased compared with that before treatment (5.86±3.02) (Z＝-2.38,P＝0.018).Eleven times of adverse events were found in nine patients,infusion reaction and respiratory tract infection were more common and no severe adverse effect was observed.Conclusions IFX can rapidly improve clinical symptoms and with good safety.The effects in mucosal healing and fistula closure may occur at early medication.