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经鼻内镜外路鼻腔泪囊吻合术治疗原发性鼻泪管阻塞术后术区局部应用 vs 单次静脉推注抗生素预防手术部位感染的随机对照研究

Oral versus single intravenous bolus dose antibiotic prophylaxis against postoperative surgical site infection in external dacryocystorhinostomy for primary acquired nasolacrimal duct obstruction - A randomized study.

机构信息

Ophthalmic Plastics, Orbit and Ocular Oncology Services, LV Prasad Eye Institute, Bhubaneswar, Odisha, India.

出版信息

Indian J Ophthalmol. 2019 Mar;67(3):382-385. doi: 10.4103/ijo.IJO_616_18.

Abstract

PURPOSE

To compare the efficacy of a single perioperative bolus dose of intravenous antibiotic versus postoperative oral antibiotic prophylaxis for prevention of surgical site infection (SSI) in external dacryocystorhinostomy (DCR) for primary acquired nasolacrimal duct obstruction (PANDO).

METHODS

This was a prospective randomized controlled study with a noninferiority design. Patients undergoing external DCR surgery were randomized into two groups A and B. Patients in group A received a single bolus dose of intravenous cefazolin 1 g at surgery, whereas those in group B received oral cephalexin 500 mg postoperatively twice a day for 5 days. Allocation concealment was ensured by sequentially numbered opaque sealed envelopes (SNOSEs). Both groups were advised identical postoperative local wound care regimens. Any clinical evidence of SSI at 4 weeks of follow-up in either group was the main outcome measure.

RESULTS

In all, 338 patients randomized into two groups of 169 patients each participated in this study. At follow-up of 4 weeks, only one patient in group B developed postoperative SSI. None in group A developed postoperative SSI. Other potential risk factors for postoperative SSI were also analyzed by univariate and multivariate analyses but none achieved statistical significance in either group.

CONCLUSION

Our results demonstrate that a single bolus dose of perioperative intravenous antibiotic offers adequate prophylaxis against postoperative SSI and compares favorably with the more commonly used oral antibiotic prophylaxis in external DCR for PANDO in our population and our practice scenario.

摘要

目的

比较单次围手术期静脉注射抗生素与术后口服抗生素预防原发性获得性鼻泪管阻塞(PANDO)外 DCR 术后手术部位感染(SSI)的疗效。

方法

这是一项前瞻性随机对照研究,采用非劣效性设计。接受外 DCR 手术的患者被随机分为两组 A 和 B。组 A 患者在手术时接受 1 g 头孢唑啉静脉单次推注,而组 B 患者在手术后每天口服头孢氨苄 500 mg,分两次,共 5 天。通过连续编号的不透明密封信封(SNOSE)确保分配隐藏。两组均建议采用相同的术后局部伤口护理方案。任何一组在 4 周随访时出现的 SSI 的临床证据均为主要观察指标。

结果

共有 338 名患者随机分为两组,每组 169 名患者。在 4 周的随访中,只有 1 名组 B 患者发生术后 SSI。组 A 无患者发生术后 SSI。通过单因素和多因素分析也分析了其他可能导致术后 SSI 的危险因素,但在两组中均无统计学意义。

结论

我们的结果表明,单次围手术期静脉注射抗生素可提供足够的预防术后 SSI 的效果,与我们人群中 PANDO 外 DCR 中更常用的口服抗生素预防相比具有优势,并且符合我们的实践情况。

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