CAJ | 학술논문

目的探讨静脉输注英夫利昔单抗(IFX)联合手术治疗克罗恩病肛瘘的临床疗效和安全性.方法回顾性分析2010年3月至2011年6月间在南京中医药大学附属医院接受IFX联合手术治疗的15例克罗恩病肛瘘患者的临床资料.均在手术后第1周开始接受静脉输注IFX诱导治疗(5 mg/kg,0、2和6周).监测IFX治疗前后克罗恩病活动指数(CDAI)、肛周克罗恩病指数(PCDAI)、体质量指数(BMI)、相关血液学指标及内镜检查结果,并记录肛瘘愈合情况及IFX输注过程中的不良反应.结果 IFX治疗后14周,13例(86.7％)肛瘘完全愈合,1例局部症状改善,1例再次形成皮下瘘;肛瘘瘘管愈合时间20～45(平均32.5)d.4例伴肛管直肠狭窄明显改善.1例患者内镜下可见肠道黏膜完全愈合,其余14例肠道炎性反应显著改善.CDAI由治疗前的230.5±97.5降至114.0±90.3,PCDAI由治疗前的9.9±3.4降至2.8±3.2,BMI由治疗前的(19.1±3.1) kg/m2上升至(21.5±3.0) kg/m2,差异有统计学意义(均P＜0.01).C反应蛋白、红细胞沉降率、血小板及中性粒细胞百分比等血液学指标均较治疗前显著降低(均P＜0.01).IFX治疗期间,1例患者发生低钾血症；1例患者发生严重输液反应;其余13例患者未出现明显不良反应.结论静脉输注IFX联合手术治疗克罗恩病肛瘘安全、有效.
목적 탐토정맥수주영부리석단항(IFX)연합수술치료극라은병항루적림상료효화안전성.방법 회고성분석2010년3월지2011년6월간재남경중의약대학부속의원접수IFX연합수술치료적15례극라은병항루환자적림상자료.균재수술후제1주개시접수정맥수주IFX유도치료(5 mg/kg,0、2화6주).감측IFX치료전후극라은병활동지수(CDAI)、항주극라은병지수(PCDAI)、체질량지수(BMI)、상관혈액학지표급내경검사결과,병기록항루유합정황급IFX수주과정중적불량반응.결과 IFX치료후14주,13례(86.7％)항루완전유합,1례국부증상개선,1례재차형성피하루;항루루관유합시간20～45(평균32.5)d.4례반항관직장협착명현개선.1례환자내경하가견장도점막완전유합,기여14례장도염성반응현저개선.CDAI유치료전적230.5±97.5강지114.0±90.3,PCDAI유치료전적9.9±3.4강지2.8±3.2,BMI유치료전적(19.1±3.1) kg/m2상승지(21.5±3.0) kg/m2,차이유통계학의의(균P＜0.01).C반응단백、홍세포침강솔、혈소판급중성립세포백분비등혈액학지표균교치료전현저강저(균P＜0.01).IFX치료기간,1례환자발생저갑혈증；1례환자발생엄중수액반응;기여13례환자미출현명현불량반응.결론 정맥수주IFX연합수술치료극라은병항루안전、유효.
Objective To evaluate the efficacy of infliximab combined with surgery in the treatment of perianal fistulizing Crohn disease(CD).Methods Clinical data of 15 patients with perianal fistulizing CD receiving inflixmab combined with surgery in the Affiliated Hospital of Nanjing University of Chinese Medicine from March 2010 to June 2011 were analyzed retrospectively.One week after operation,all the patients received infliximab infusion thrice at weeks 0,2,and 6.Crohn disease activity index (CDAI),perianal Crohn disease activity index(PDAI),body mass index(BMI),routine blood test and endoscopy were evaluated at week 0,14.Adverse reactions and healing time were recorded.Results At week 14,the response rate was 100％ with 86.7％(13/15) complete responders.One patient had local improvement and one developed recurrent fistula.The mean healing time was 32.5(20-45) d.Anorectal stenosis in 4 patients was significantly improved.At week 14,CDAI decreased to 114.0±90.3 from 230.5±97.5 after IFX treatment.PCDAI decreased to 2.8±3.2 from 9.9±3.4,and BMI increased to (21.5±3.0) kg/m2 from (19.1 ±3.1) kg/m2.C-reactive protein (CRP),erythrocyte sedimentation rate(ESR),platelet and neutrophil were significantly decreased from baseline (all P＜0.01).Intestinal mucosa healed completely in one patient.There were no serious adverse events except hypopotassaemia in one patient and severe infusion reaction in another.Conclusion Inftiximab combined with surgery is effective and safe for perianal fistulizing CD.