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纤维蛋白胶注射治疗克罗恩病患者肛周瘘的长期疗效。

Long-term efficacy of fibrin glue injection for perianal fistulas in patients with Crohn's disease.

机构信息

Service de Gastroentérologie, Hôpital Saint-Louis, Paris, France.

Service de Chirurgie Digestive, Hôpital Saint-Louis, Paris, France.

出版信息

Colorectal Dis. 2021 Apr;23(4):894-900. doi: 10.1111/codi.15477. Epub 2020 Dec 29.

Abstract

AIM

The treatment of perianal fistulas in Crohn's disease remains challenging. Fibrin glue injection has previously shown short-term efficacy in a randomized controlled trial. No long-term data are available to assess the benefit of this treatment.

METHODS

This retrospective multicentre study included all patients with drained fistulas treated by at least one fibrin glue injection between January 2004 and June 2015 in three tertiary French centres. The primary end-point was the rate of complete clinical remission at 1 year after injection defined by the closure of all fistula tracts with no need for iterative anal surgery or for optimization of immunosuppressants and/or biologics.

RESULTS

In all, 119 patients (median age 33 years, complex fistulas 65%, median previous anal surgery two, median Harvey Bradshaw score 3, immunosuppressants exposure 50%, anti-tumor necrosis factor exposure 60% with median time of administration of 1.1 year) were analysed with a median follow-up of 18.3 months. The complete clinical remission rate at 1 year was 45.4%. The primary end-point was achieved in 63% of the cases in the combination therapy group and 37% in other patients. The only predictor of complete clinical remission at 1 year was combination therapy at the time of injection (P = 0.01). The rate of early reintervention after glue injection was 2.5%. The cumulative incidence of iterative anal surgery and ostomy in the whole population was 54% and 5.6% respectively at 5 years.

CONCLUSION

An adjunct of fibrin glue to conventional medical therapy may be an effective and safe treatment for perianal fistulas in patients with Crohn's disease.

摘要

目的

克罗恩病肛周瘘的治疗仍然具有挑战性。纤维蛋白胶注射在一项随机对照试验中显示出短期疗效。目前尚无长期数据评估这种治疗的益处。

方法

本回顾性多中心研究纳入了 2004 年 1 月至 2015 年 6 月期间在法国三个三级中心接受至少一次纤维蛋白胶注射治疗的所有引流性瘘患者。主要终点是注射后 1 年完全临床缓解的发生率,定义为所有瘘道闭合,无需反复行肛门手术,也无需优化免疫抑制剂和/或生物制剂。

结果

共分析了 119 例患者(中位年龄 33 岁,复杂瘘管占 65%,中位既往肛门手术 2 次,中位 Harvey Bradshaw 评分 3 分,免疫抑制剂暴露 50%,抗 TNF 暴露 60%,中位治疗时间为 1.1 年),中位随访时间为 18.3 个月。1 年时完全临床缓解率为 45.4%。联合治疗组和其他患者中,主要终点的实现率分别为 63%和 37%。1 年时完全临床缓解的唯一预测因素是注射时联合治疗(P=0.01)。注射后早期再次干预的发生率为 2.5%。在整个研究人群中,5 年内再次行肛门手术和造口术的累积发生率分别为 54%和 5.6%。

结论

纤维蛋白胶联合常规药物治疗可能是克罗恩病肛周瘘的有效、安全的治疗方法。

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