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常规第三磨牙手术切除时的围手术期预防性抗生素应用是否仍合理?一项随机、双盲、安慰剂对照、劈裂口腔设计的临床试验。

Is perioperative antibiotic prophylaxis in the case of routine surgical removal of the third molar still justified? A randomized, double-blind, placebo-controlled clinical trial with a split-mouth design.

机构信息

Department of Dental Medicine and Oral Health, Division of Oral Surgery and Orthodontics, Medical University of Graz, Billrothgasse 4, 8010, Graz, Austria.

Department of Oral Surgery, University Center for Dental Medicine Basel (UZB), University of Basel, Mattenstrasse 40, 4058, Basel, Switzerland.

出版信息

Clin Oral Investig. 2022 Oct;26(10):6409-6421. doi: 10.1007/s00784-022-04597-5. Epub 2022 Jul 6.

DOI:10.1007/s00784-022-04597-5
PMID:35792962
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9525439/
Abstract

INTRODUCTION

Since antimicrobial resistance, caused by various factors including antibiotic overuse and abuse, is a severe challenge, the necessity of perioperative antibiotic prophylactic for surgical third molar removal remains a contentious topic. This study determined whether perioperative antibiotic prophylaxis can reduce surgical site infections (SSIs), swelling, and pain in the case of surgical removal of wisdom teeth.

MATERIAL AND METHODS

A randomized, double-blind, placebo-controlled clinical trial with a split-mouth design. A study medication of 2 g amoxicillin, administered 1 h before the third molar removal, followed by 1.5 g each for the first 3 postoperative days, was compared with placebo medication. The primary outcome variable (SSI), secondary clinical parameters (swelling and trismus), and patient-centered outcome measures (bleeding, swelling, pain, and pain medication intake) were documented until postoperative day 7. Statistical analyses were done with a paired t test, t test for independent samples, Chi-square test, and McNemar test, including effect sizes.

RESULTS

Primary outcome SSI, in total 11%, and clinical parameters swelling and trismus were not significantly different between the two groups. The patient-centered outcome measures (bleeding, swelling, and pain) did not significantly differ, except for postoperative bleeding in the EG on day 0. No significant result was found with pain medication intake postoperative on days 0-7.

CONCLUSIONS

Perioperative administration of oral antibiotics neither revealed additional benefits in patient-related outcome measures nor reduced postoperative complications compared with the placebo group indicated at routine surgical removal of noninflamed wisdom teeth.

CLINICAL RELEVANCE

Taking antimicrobial resistance into account, clear recommendations for administering drugs, particularly antibiotics, are critical in oral surgery.

摘要

简介

由于抗生素耐药性是一个严重的挑战,其由抗生素过度使用和滥用等多种因素引起,因此,对于第三磨牙手术切除是否需要进行围手术期预防性使用抗生素仍存在争议。本研究旨在确定围手术期预防性使用抗生素是否可以降低手术部位感染(SSI)、肿胀和疼痛的风险,从而改善接受第三磨牙手术切除的患者的预后。

材料和方法

采用随机、双盲、安慰剂对照的临床试验设计,裂口腔设计。研究药物为 2 g 阿莫西林,在第三磨牙拔除前 1 小时给药,然后在术后第 1、2、3 天各给予 1.5 g,与安慰剂药物进行比较。主要结局变量(SSI)、次要临床参数(肿胀和牙关紧闭)和以患者为中心的结局指标(出血、肿胀、疼痛和止痛药摄入)记录至术后第 7 天。统计分析采用配对 t 检验、独立样本 t 检验、卡方检验和 McNemar 检验,包括效应大小。

结果

主要结局 SSI 总发生率为 11%,两组间无统计学差异,且肿胀和牙关紧闭等临床参数也无显著差异。以患者为中心的结局指标(出血、肿胀和疼痛)无显著差异,除了 EG 组在术后第 0 天的术后出血。术后第 0-7 天止痛药摄入无显著差异。

结论

与安慰剂组相比,在常规切除非炎症性第三磨牙的手术中,围手术期给予口服抗生素并没有在患者相关结局测量方面显示出额外的益处,也没有减少术后并发症。

临床意义

考虑到抗菌药物耐药性,在口腔外科中,给予药物特别是抗生素的明确建议非常重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7eb1/9525439/d342925c8bd0/784_2022_4597_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7eb1/9525439/d342925c8bd0/784_2022_4597_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7eb1/9525439/d342925c8bd0/784_2022_4597_Fig2_HTML.jpg

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