中国实用外科杂志

中国实用外科杂志 ›› 2023, Vol. 43 ›› Issue (07): 791-795.DOI: 10.19538/j.cjps.issn1005-2208.2023.07.16

• 论著 • 上一篇    下一篇

阿达木单抗联合肛周挂线引流术治疗克罗恩病肛瘘临床疗效分析

王    浩1，卢    璐2，谷云飞1，孙晓梅3，李悠然1   

  1. 1 江苏省中医院 南京中医药大学附属医院肛肠科，江苏南京 210029；2 绍兴市中医院 浙江中医药大学附属绍兴中医院消化科，浙江绍兴 312000；3青岛大学附属医院肛肠科，山东青岛 266003
  • 出版日期:2023-07-01 发布日期:2023-07-23

  • Online:2023-07-01 Published:2023-07-23

摘要： 目的    评估阿达木单抗联合肛周挂线引流术治疗克罗恩病肛瘘的临床疗效和安全性，并分析影响瘘管应答的因素。方法    回顾性分析2020年1月至2022年3月南京中医药大学附属医院肛肠科收治的45例克罗恩病肛瘘病人的临床资料，计算克罗恩病活动指数（CDAI）、肛周疾病活动指数（PDAI）、克罗恩病简化内镜评分（SES-CD），评估瘘管愈合情况，比较治疗前后C反应蛋白（CRP）、红细胞沉降率（ESR）变化，分析可能影响瘘管应答的因素。结果    随访时间为8.9（6~16）个月。观察终点时瘘管应答率为73.3%（33/45），瘘管临床愈合率为46.7%（21/45），瘘管影像学愈合率为31.1%（14/45）；临床应答率为62.2%（28/45），临床缓解率为46.7%（21/45）。其中23例病人复查内镜，内镜应答率为69.6%（16/23），内镜缓解率为60.9%（14/23）。治疗3个月后，CDAI ［316（249，413.5）分 vs. 175（123.5，334）分］、PDAI ［8（7，12）分 vs. 6（3，9）分］、SES-CD ［5（3.0，6.3）分 vs. 2（0，5）分］、CRP ［7.85（4.3，15.5）mg/L vs. 3.86（1.4，9.7）mg/L］、ESR ［27（16.0，45.5）mm/h vs. 17（9.0，34.5）mm/h］较治疗前明显下降，差异有统计学意义（P<0.05）。不良事件发生率为13.3%。多因素Logistic回归分析显示，阿达木单抗作为一线用药（OR=5.199，95%CI 1.033-26.155，P=0.046）是瘘管应答的独立保护因素。结论    阿达木单抗联合肛周挂线引流术治疗克罗恩病肛瘘安全有效，可有效改善肛周症状。

关键词: 肛瘘, 克罗恩病, 阿达木单抗, 安全性, 缓解, 应答

Abstract: The safety and efficacy of Adalimumab combined with perianal loose seton for perianal fistulizing Crohn disease        WANG Hao*, LU Lu, GU Yun-fei, et al. *Department of Anorectum, Jiangsu Provincial Hospital of Chinese Medicine & Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China
Corresponding author: LI You-ran, E-mail: magic8811@sina.com
Abstract    Objective    To assess the clinical efficacy and safety of adalimumab (ADA) combined with a perianal loose seton in the treatment of perianal fistulizing Crohn’s disease (pfCD) and to analyze risk factors that affect the fistula response. Methods    A single-center retrospective study. The baseline data of pfCD patients who met the inclusion and exclusion criteria and visited the Anorectal Department of the Affiliated Hospital of Nanjing University of Traditional Chinese Medicine from January 2020 to March 2022 were collected. Crohn’s Disease activity index, perianal disease activity index, simplified endoscopic score for Crohn’s Disease, fistula response and remission were assessed.The differences in inflammatory parameters, including C-reactive protein and Erythrocyte sedimentation rate, at 3 months after treatment were statistically analyzed. The incidence of adverse events was recorded. Risk factors affecting fistula response were analyzed. Results    A total of 45 pfCD patients were included, with a median follow-up of 8.9(6~16)months. At endpoint of observation. 73.3%(33/45) of patients achieved fistula response, 46.7%(21/45)achieved fistula remission, and 31.1%(14/45) achieved fistula remission under MRI; 62.2%(28/45) achieved clinical response and 46.7%(21/45) achieved clinical remission. A total of 23 patients completed endoscopic reexamination, including 69.6% of patients (16/23) with endoscopic response and 60.9%(14/23) with endoscopic remission. After 3 months of treatment, CDAI ［316(249, 413.5) vs. 175(123.5, 334)］, PDAI ［8(7, 12) vs. 6(3, 9)］, SES-CD ［5(3.0, 6.3) vs. 2(0, 5)］, CRP ［7.85(4.3, 15.5)mg/L vs. 3.86(1.4, 9.7)mg/L］ and ESR ［27(16.0, 45.5) mm/h vs. 17(9.0, 34.5)mm/h］ were significantly lower than those before treatment (P < 0.05). The incidence of adverse events was 13.3%. Multivariate Logistic regression analysis showed that adalimumab as first-line treatment (OR=5.199, 95%CI 1.033-26.155, P=0.046) was an independent protective factor of fistula response. Conclusion    ADA combined with perianal loose seton is safe and effective in the treatment of pfCD.This therapy can effectively improve the fistula condition in pfCD patients.

Key words: perianal fistulizing, Crohn disease, adalimumab, safety, remission, response