CAJ | 학술논문

目的评价改良括约肌间瘘管结扎术(LIFT-plug)术式在慢性肛瘘治疗中的有效性及安全性.方法选择2011年3月至2013年4月首都医科大学附属北京朝阳医院等5家医院收治的239例慢性肛瘘患者,其中男199例(83.26％),女40例(16.74％),对照表随机分配入试验组(脱细胞黏膜组)或对照组(单纯手术组),试验组和对照组分别完成入组病例1 19例和120例,试验组采用LIFT-plug术式,对照组采用保留括约肌手术(UFT)术式,术后随访180 d.统计术后180 d内的治愈率和中位愈合时间,评估术后复发率、术后疼痛、肛门失禁率及材料安全相关.本研究得到北京朝阳医院伦理委员会批准,患者均签署知情同意书.结果术后第180天脱细胞黏膜组愈合率为96.5％,单纯手术组愈合率为83.7％,脱细胞黏膜组中位术后愈合时间为22 d,单纯手术组中位术后愈合时间为30 d,组间术后愈合率和中位愈合时间差异有统计学意义.本次试验随访180 d期间无复发.术后标准数字评分法(VAS)疼痛评分术后第2、3天差异有统计学意义,其余随访时间VAS评分差异均无统计学意义.术后肛门失禁评分差异无统计学意义,均未发生严重的肛门失禁,试验组未发生与研究器械有关的不良事件.结论 LIFT-plug术式较之LIFT术式愈合率高,愈合时间短,组织损伤程度小,无肛门失禁发生,操作简单,是一种针对经慢性肛瘘更理想的方法.
목적 평개개량괄약기간루관결찰술(LIFT-plug)술식재만성항루치료중적유효성급안전성.방법 선택2011년3월지2013년4월수도의과대학부속북경조양의원등5가의원수치적239례만성항루환자,기중남199례(83.26％),녀40례(16.74％),대조표수궤분배입시험조(탈세포점막조)혹대조조(단순수술조),시험조화대조조분별완성입조병례1 19례화120례,시험조채용LIFT-plug술식,대조조채용보류괄약기수술(UFT)술식,술후수방180 d.통계술후180 d내적치유솔화중위유합시간,평고술후복발솔、술후동통、항문실금솔급재료안전상관.본연구득도북경조양의원윤리위원회비준,환자균첨서지정동의서.결과 술후제180천탈세포점막조유합솔위96.5％,단순수술조유합솔위83.7％,탈세포점막조중위술후유합시간위22 d,단순수술조중위술후유합시간위30 d,조간술후유합솔화중위유합시간차이유통계학의의.본차시험수방180 d기간무복발.술후표준수자평분법(VAS)동통평분술후제2、3천차이유통계학의의,기여수방시간VAS평분차이균무통계학의의.술후항문실금평분차이무통계학의의,균미발생엄중적항문실금,시험조미발생여연구기계유관적불량사건.결론 LIFT-plug술식교지LIFT술식유합솔고,유합시간단,조직손상정도소,무항문실금발생,조작간단,시일충침대경만성항루경이상적방법.
Objective To evaluate the effectiveness and safety of Ligation of the Intersphincteric Fistula Tract Plus Bioprosthetic Anal Fistula Plug (LIFF-plug) in the treatment of chronic anal fistula.Methods A total of 239 patients (199 males,40 females) with chronic anal fistula were recruited from 5 hospitals between March 2011 and April 2013.These patients were randomly assigned to the experimental group (n =119) treated with LIFT-plug or the control group (n =120) treated with LIFT.The follow-up period was 180 days.The collected data included healing rate,the median healing time,the recurrence rate,the Visual Analogue Scale (VAS),the incontinence rate,and the safety indicators associated with the anal fistula plug.Results The healing rate of the experimental group was better than the control group (96.5％ vs 83.7％,P ＜0.05).The median healing time of the experimental group was 22 days and the latter was 30 days (P ＜ 0.05).By the end of the follow-up period,there was no recurrence found in the two groups The VAS and the incontinence rate had no statistically significant difference between the two groups.There were no adverse events associated with the anal fistula plug in the experimental group.Conclusion LIFT-plug is simple,less invasive,and with shorter healing time and more satisfactory healing rate in treating chronic anal fistula compared with LIFT.