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局部庆大霉素-胶原蛋白治疗在肛瘘推进皮瓣修复中的随机临床试验。

Randomized clinical trial of local gentamicin-collagen treatment in advancement flap repair for anal fistula.

作者信息

Gustafsson U-M, Graf W

机构信息

Department of Surgery, University Hospital, S-751 85 Uppsala, Sweden.

出版信息

Br J Surg. 2006 Oct;93(10):1202-7. doi: 10.1002/bjs.5398.

DOI:10.1002/bjs.5398
PMID:16952209
Abstract

BACKGROUND

Endoanal advancement flap repair is widely used in sphincter-preserving surgery for anal fistula, but the high recurrence rate is a major problem. A possible cause of non-healing is local infection of the flap. The aim of this study was to evaluate whether local antibiotic treatment with gentamicin-collagen improves healing after endoanal advancement flap repair for anal fistula.

METHODS

Eighty-three patients (52 men and 31 women; mean age 47 (range 17-71) years) who had endoanal advancement flap repair for anal fistula between September 1998 and January 2004 were randomized to surgery with (42 patients) or without (41 patients) application of gentamicin-collagen beneath the flap. Patients were evaluated at 1-3 and 12 months after surgery for healing and/or recurrence.

RESULTS

The overall healing rate with no recurrence at 1 year after surgery was 57 per cent (47 of 83). Twenty-six of 42 patients randomized to gentamicin-collagen healed primarily compared with 21 of 41 patients randomized to surgery only. There were no overall differences in healing rate according to sex, previous fistula surgery, complexity of fistula, smoking habit or body mass index.

CONCLUSION

Endoanal advancement flap repair for anal fistula has a fairly high primary recurrence rate. Healing was not significantly improved by local application of gentamicin-collagen.

摘要

背景

肛管推进皮瓣修复术在肛瘘保留括约肌手术中广泛应用,但高复发率是一个主要问题。皮瓣不愈合的一个可能原因是局部感染。本研究的目的是评估庆大霉素 - 胶原局部抗生素治疗是否能改善肛瘘肛管推进皮瓣修复术后的愈合情况。

方法

1998年9月至2004年1月期间接受肛瘘肛管推进皮瓣修复术的83例患者(52例男性和31例女性;平均年龄47岁(范围17 - 71岁))被随机分为两组,一组42例在皮瓣下应用庆大霉素 - 胶原进行手术,另一组41例未应用。在术后1 - 3个月和12个月对患者进行愈合和/或复发情况评估。

结果

术后1年无复发的总体愈合率为57%(83例中的47例)。随机分组接受庆大霉素 - 胶原治疗的42例患者中,26例一期愈合,而随机分组仅接受手术的41例患者中,有21例一期愈合。根据性别、既往肛瘘手术史、肛瘘复杂性、吸烟习惯或体重指数,愈合率无总体差异。

结论

肛瘘肛管推进皮瓣修复术的原发性复发率相当高。局部应用庆大霉素 - 胶原并未显著改善愈合情况。

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