引流后辅助抗生素治疗是否可预防肛门直肠脓肿发展为肛瘘？一项随机、安慰剂对照、双盲、多中心研究。

Does adjuvant antibiotic treatment after drainage of anorectal abscess prevent development of anal fistulas? A randomized, placebo-controlled, double-blind, multicenter study.

机构信息

Department of General Surgery, Ankara University School of Medicine, Ankara, Turkey.

出版信息

Dis Colon Rectum. 2011 Aug;54(8):923-9. doi: 10.1097/DCR.0b013e31821cc1f9.

DOI:10.1097/DCR.0b013e31821cc1f9

PMID:21730779

Abstract

BACKGROUND

The risk of fistula formation is a major concern after incision and drainage of an anorectal abscess.

OBJECTIVE

Our objective was to the test the effects of antibiotic treatment on fistula formation after incision and drainage of anorectal abscesses.

DESIGN

Randomized, placebo-controlled, double-blind study.

SETTING

Multicenter trial at 3 teaching hospitals in Turkey.

PATIENTS

Patients who underwent abscess drainage between September 2005 and January 2008 were evaluated for eligibility. Exclusion criteria included penicillin allergy, antimicrobial agent usage before enrolment, other infection, previous anorectal surgery, inflammatory bowel disease, suspicion of Fournier gangrene, secondary and recurrent anorectal abscesses, anal fistula at time of the surgery, immune compromised states, and pregnancy.

INTERVENTION

Patients were randomly assigned to receive placebo or amoxicillin-clavulanic acid combination treatment for 10 days after abscess drainage.

MAIN OUTCOME MEASURES

The primary end point was rate of anorectal fistula formation at 1-year follow-up.

RESULTS

: Of 334 patients assessed for eligibility, 183 entered the study (placebo, 92; antibiotics, 91). Data were available for per-protocol analysis from 151 patients (placebo, 76; antibiotics, 75) with a mean age of 37.6 years; 118 patients (78.1%) were men. Overall, 45 patients (29.8%) developed anal fistulas during 1-year follow-up. Fistula formation occurred in 17 patients (22.4%) in the placebo group and in 28 patients (37.3%) in the antibiotic group (P = .044). Risk of fistula formation was increased in patients with ischiorectal abscess (odds ratio, 7.82) or intersphincteric abscess (odds ratio, 3.35) compared with perianal abscess.

CONCLUSION

Antibiotic treatment following the drainage of an anorectal abscess has no protective effect regarding risk of fistula formation.

摘要

背景

肛门直肠脓肿切开引流后，瘘管形成的风险是一个主要关注点。

目的

我们旨在检验抗生素治疗对肛门直肠脓肿切开引流后瘘管形成的影响。

设计

随机、安慰剂对照、双盲研究。

地点

土耳其 3 所教学医院的多中心试验。

患者

评估 2005 年 9 月至 2008 年 1 月期间接受脓肿引流的患者是否符合入选标准。排除标准包括青霉素过敏、入组前使用抗菌药物、其他感染、既往肛门直肠手术、炎症性肠病、怀疑 Fournier 坏疽、继发和复发性肛门直肠脓肿、手术时存在肛瘘、免疫功能低下状态和妊娠。

干预

患者在脓肿引流后随机分配接受安慰剂或阿莫西林-克拉维酸联合治疗 10 天。

主要结局测量

主要终点是 1 年随访时肛瘘形成率。

结果

共评估了 334 例符合条件的患者，其中 183 例进入研究（安慰剂组 92 例，抗生素组 91 例）。151 例患者（安慰剂组 76 例，抗生素组 75 例）的数据可用于意向治疗分析，平均年龄为 37.6 岁；118 例患者（78.1%）为男性。总体而言，1 年随访期间有 45 例（29.8%）患者发生肛瘘。安慰剂组有 17 例（22.4%）患者和抗生素组有 28 例（37.3%）患者发生瘘管（P =.044）。与肛周脓肿相比，坐骨直肠脓肿（比值比，7.82）或括约肌间脓肿（比值比，3.35）患者的瘘管形成风险增加。