Objective: To evaluate the long-term healing rate of transsphincteric anal fistula treated with anal fistula plug procedure and the risk factors affecting the healing of anal fistula. Methods: A retrospective case-control study was conducted to analyze the clinical data of 207 patients with transsphincteric anal fistulas who received anal fistula plug procedure at the Department of General Surgery, Beijing Chaoyang Hospital of Capital Medical University from August 2008 to September 2012. Inclusion criteria: (1) consistent with the diagnosis of transsphincteric anal fistula: the anal fistula passed through the internal and external sphincter; (2) complete data; (3) initial treatment with anal fistula plug procedure. Exclusion criteria: (1) acute rectal or perianal infection or poorly controlled focal infection; (2) recent incision and drainage of perianal abscess or spontaneous rupture of abscess; (3) patients with malignant tumor; (4) patients with Crohn's disease or ulcerative colitis; (5) patients with heart, liver, brain, lung or renal insufficiency; (6) cachexia due to various chronic wasting diseases; (7) patients could not tolerate surgery. Patients were followed up for anal fistula healing. The cumulative healing rate of patients with transsphincteric anal fistula was plotted using the Kaplan-Meier method, and the factors affecting anal fistula healing were explored by univariate and multivariate logistic regression analysis. Results: There were 186 males and 21 females with age of 15 to 69 (mean 38) years. The duration of anal fistula was 3-60 (mean 15) months. Three patients had a history of previous episodes of perianal abscess and underwent incision and drainage of perianal abscess (all more than 3 months). During follow-up ending on October 31, 2018, 72 patients (34.8%) were lost to follow-up. Among 135 patients who were successfully followed up, the average follow-up period was 96 (75-124) months. Seventy-five patients had anal fistula healing, with healing rate of 55.6%. Kaplan-Meier survival curve showed that the healing time of anal fistula was prolonged and finally stabilized at 55.6%. In the patients who failed initial treatment with anal fistula plug packing, there were 6 cases whose anal fistula healed spontaneously without other treatment. Among them, 3 cases healed spontaneously 2 years and 3 cases 3 years after operation without recurrence. From 2008 to 2012, the annual healing rates of anal fistula plug treatment were 3/6, 61.5% (24/39), 42.1% (24/57), 12/15 and 12/18, respectively. Multivariate logistic regression analysis showed that the duration of anal fistula≥6 months (OR=3.187, 95% CI: 1.361-7.466, P=0.008) was an independent risk factor for anal fistula healing after treatment with anal fistula plug. Conclusion: The long-term efficacy of anal fistula plug procedure in the treatment of transsphincteric anal fistula is positive, and this procedure should be implemented as soon as possible.
目的： 评估肛瘘栓填塞治疗经括约肌型肛瘘的长期愈合率及影响肛瘘愈合的因素。 方法： 采用回顾性病例对照研究方法，分析2008年8月至2012年9月期间于首都医科大学附属北京朝阳医院普通外科接受肛瘘栓填塞治疗的207例经括约肌型肛瘘患者的临床资料。患者纳入标准：（1）符合经括约肌型肛瘘的诊断：即瘘管穿越内括约肌及外括约肌的浅、深部之间；（2）患者病例资料完整；（3）初始接受肛瘘栓填塞治疗。排除标准：（1）直肠肛管周围急性感染或病灶感染控制不佳；（2）近期行直肠肛管周围脓肿切开引流术或自行破溃者；（3）合并有恶性肿瘤；（4）克罗恩病、炎性肠病者；（5）心、肝、脑、肺、肾功能不全者；（6）各种慢性消耗性疾病造成恶病质；（7）不能耐受手术者。随访患者的肛瘘愈合情况，采用Kaplan-Meier法绘制肛瘘患者累计治愈率，并用单因素和多因素logistic回归分析探究影响肛瘘愈合的因素。 结果： 全组男性186例，女性21例，年龄15~69（平均数38）岁。肛瘘病程3~60（平均数15）个月。有3例患者既往有肛周脓肿发作史并且行肛周脓肿切开引流术（均超过3个月）。随访截至2018年10月31日，失访72例（34.8%）。在135例成功随访的患者中，平均随访时间为96（75~124）个月，肛瘘愈合75例，愈合率为55.6%。Kaplan-Meier生存曲线显示，肛瘘治愈率随时间延长，最终稳定在55.6%。在初次接受肛瘘栓填塞治疗失败的患者中，有6例在未接受其他治疗的情况下，肛瘘自行愈合。其中，3例于术后2年、3例于术后3年自行愈合，并未再复发。2008—2012年，肛瘘栓填塞治疗的年治愈率分别为3/6、61.5%(24/39)、42.1%(24/57)、12/15和12/18。多因素logistic回归分析显示，肛瘘病程≥6个月（OR=3.187，95%CI：1.361~7.466，P=0.008）是影响肛瘘栓填塞治疗后肛瘘愈合的独立危险因素。 结论： 肛瘘栓填塞治疗经括约肌型肛瘘长期疗效肯定，宜尽早实施。.
Keywords: Anal fistula plug; Anal fistulas, transsphincteric; Long-term efficacy.