环状激光闭合手术联合英夫利西单克隆抗体治疗复杂性克罗恩病肛瘘的有效性和安全性分析  

Efficacy and safety of combined treatment with FiLaC^(TM)surgery and infliximab for complex perianal fistulizing Crohn's disease

作　　者：王晓辉 钱可与 张诚[2] 徐可 何建 朱明明[7] 张晔 崔喆[1,2,3,6] 曹冬兴 Wang Xiaohui;Qian Keyu;Zhang Cheng;Xu Ke;He Jian;Zhu Mingming;Zhang Ye;Cui Zhe;Cao Dongxing(Department of General Surgery,Baoshan Branch,Renji Hospital,School of Medicine,Shanghai Jiaotong University,Shanghai 200444,China;Department of Gastrointestinal Surgery,Renji Hospital,School of Medicine,Shanghai Jiaotong University,Shanghai 200127,China;Institute of Translational Medicine,Shanghai University,Shanghai 200444,China;Organoid Research Center,Shanghai University,Shanghai,200444,China;Wenzhou Institute of Shanghai University,Wenzhou 325000,China;Department of General Surgery,Anhui No.2 Provincial People's Hospital,Hefei 230041,China;Division of Gastroenterology and Hepatology,Renji Hospital,School of Medicine,Shanghai Jiaotong University,Shanghai 200127,China)

机构地区：[1]上海交通大学医学院附属仁济医院宝山分院普通外科,上海200444 [2]上海交通大学医学院附属仁济医院胃肠外科,上海200127 [3]上海大学转化医学研究院,上海200444 [4]上海大学类器官研究中心,上海200444 [5]上海大学温州研究院,温州325000 [6]安徽省第二人民医院普外科,合肥230041 [7]上海交通大学医学院附属仁济医院消化科,上海200127

出　　处：《中华炎性肠病杂志（中英文）》2024年第5期390-394,共5页Chinese Journal of Inflammatory Bowel Diseases

基　　金：上海市科创基金(22S31903500);上海宝山区重点专科(BSZK-2023-A05);上海市宝山区科学技术委员会科技创新专项资金项目(2023-E-11、2023-E-12)。

摘　　要：目的评估环状激光闭合手术(FiLaCTM)联合英夫利西单克隆抗体(IFX)治疗复杂性克罗恩病肛瘘(pfCD)的有效性和安全性。方法回顾性纳入2019年2月至2020年8月期间在上海交通医学院附属仁济医院宝山分院普外科和上海交通大学医学院附属仁济医院胃肠外科接受IFX和FiLaCTM治疗的复杂性pfCD患者。术前采取挂线引流和药物诱导,药物方案为IFX或IFX联合免疫抑制剂,达到CD缓解期后采用FiLaCTM进行确定性手术。术前记录基本信息,定期随访至术后24个月,评估瘘管愈合情况,记录出血、大便失禁、术后疼痛等不良事件评估安全性。术前和术后24个月分别进行Wexner大便失禁评分和克罗恩病肛瘘生活质量评分(CAF-QoL)。结果共纳入30例患者,男性23例,女性7例。中位年龄23.6(18.0,30.5)岁。术后24个月21例(70.0%)患者临床治愈;2例(6.7%)肛瘘临床改善;2例(6.7%)未愈合,其中1例经再次FiLaCTM愈合,另1例重新挂线;5例(16.7%)复发,均重新挂线治疗。术后24个月Wexner大便失禁评分低于术前[2.0(1.8,3.0)分比2.0(2.0,3.0)分,P=0.001]。术后24个月CAF-QoL评分高于术前[39.5(33.8,62.3)分比37.5(30.0,56.3)分,P=0.03]。术后未见大便失禁、尿失禁、出血等并发症;27例(90.0%)出现轻度疼痛、1例(3.3%)中度疼痛,均自行缓解。结论FiLaCTM手术联合IFX治疗复杂性pfCD有效、安全。Objective To evaluate the effectiveness and safety of fistula-tract lase closure(FiLaC TM)surgery combined with the infliximab(IFX)for treating complex perianal fistulizing Crohn's disease(pfCD).Methods A retrospective was conducted.Patients with pfCD undergoing FiLaC TM at Renji Hospital,Shanghai Jiaotong University School of Medicine between February 2019 and August 2020 were retrospectively enrolled.The preoperative protocol included seton drainage and pharmacological induction,utilizing IFX alone or in combination with immunosuppressants.After achieving remission in CD,patients underwent definitive surgery with FiLaC TM.Clinical outcomes and adverse events such as bleeding,pain,and fecal incontinence following FiLaC TM were recorded.The Wexner fecal incontinence score and Crohn's anal fistula quality of life scale(CAF-QoL)were assessed both preoperatively and 24 months postoperatively.Results The study included 30 patients(23 males,7 females)with a median age of 23.6(18.0,30.5)years.At 24 months postoperatively,21 patients(70.0%)achieved clinical cure;2 patients(6.7%)showed improvement;2 patients(6.7%)did not heal,with one eventually healing after a repeat FiLaC TM procedure and the other requiring re-seton placement;5 patients(16.7%)relapsed and required re-seton.The Wexner fecal incontinence score at 24 months postoperatively was lower compared to preoperative scores[2.0(1.8,3.0)vs.2.0(2.0,3.0),P=0.001].The postoperative CAF-QoL scores were higher as compared to the preoperative score[39.5(33.8,62.3)vs.37.5(30.0,56.3),P=0.03].There were no complications such as fecal incontinence,urinary incontinence,or bleeding postoperatively.Twenty-seven patients(90%)experienced mild pain,and 1(3.3%)reported moderate pain,all resolving without intervention.Conclusion Combined treatment with FiLaC TM and IFX is both effective and safe for managing complex pfCD.

关 键 词：克罗恩病 肛瘘 环状激光闭合技术 英夫利西单克隆抗体 瘘管愈合 

分 类 号：R657.16[医药卫生—外科学]