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缺失牙修复干预措施:种植牙植入时使用抗生素预防并发症。

Interventions for replacing missing teeth: antibiotics at dental implant placement to prevent complications.

作者信息

Esposito Marco, Grusovin Maria Gabriella, Worthington Helen V

机构信息

Cochrane Oral Health Group, School of Dentistry, The University of Manchester, Manchester, UK.

出版信息

Cochrane Database Syst Rev. 2013 Jul 31;2013(7):CD004152. doi: 10.1002/14651858.CD004152.pub4.

DOI:10.1002/14651858.CD004152.pub4
PMID:23904048
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6786879/
Abstract

BACKGROUND

Some dental implant failures may be due to bacterial contamination at implant insertion. Infections around biomaterials are difficult to treat, and almost all infected implants have to be removed. In general, antibiotic prophylaxis in surgery is only indicated for patients at risk of infectious endocarditis; with reduced host-response; when surgery is performed in infected sites; in cases of extensive and prolonged surgical interventions; and when large foreign materials are implanted. A variety of prophylactic systemic antibiotic regimens have been suggested to minimise infections after dental implant placement. More recent protocols recommended short-term prophylaxis, if antibiotics have to be used. Adverse events may occur with the administration of antibiotics, and can range from diarrhoea to life-threatening allergic reactions. Another major concern associated with the widespread use of antibiotics is the selection of antibiotic-resistant bacteria. The use of prophylactic antibiotics in implant dentistry is controversial.

OBJECTIVES

To assess the beneficial or harmful effects of systemic prophylactic antibiotics at dental implant placement versus no antibiotic or placebo administration and, if antibiotics are beneficial, to determine which type, dosage and duration is the most effective.

SEARCH METHODS

We searched the Cochrane Oral Health Group's Trials Register (to 17 June 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 5), MEDLINE via OVID (1946 to 17 June 2013) and EMBASE via OVID (1980 to 17 June 2013). There were no language or date restrictions placed on the searches of the electronic databases.

SELECTION CRITERIA

Randomised controlled clinical trials (RCTs) with a follow-up of at least three months, that compared the administration of various prophylactic antibiotic regimens versus no antibiotics to people undergoing dental implant placement. Outcome measures included prosthesis failures, implant failures, postoperative infections and adverse events (gastrointestinal, hypersensitivity, etc).

DATA COLLECTION AND ANALYSIS

Screening of eligible studies, assessment of the risk of bias of the trials and data extraction were conducted in duplicate and independently by two review authors. Results were expressed as risk ratios (RRs) using a random-effects model for dichotomous outcomes with 95% confidence intervals (CIs). Heterogeneity, including both clinical and methodological factors, was to be investigated.

MAIN RESULTS

Six RCTs with 1162 participants were included: three trials compared 2 g of preoperative amoxicillin versus placebo (927 participants), one compared 3 g of preoperative amoxicillin versus placebo (55 participants), one compared 1 g of preoperative amoxicillin plus 500 mg four times a day for two days versus no antibiotics (80 participants), and one compared four groups: (1) 2 g of preoperative amoxicillin; (2) 2 g of preoperative amoxicillin plus 1 g twice a day for seven days; (3) 1 g of postoperative amoxicillin twice a day for seven days, and (4) no antibiotics (100 participants). The overall body of evidence was considered to be of moderate quality. The meta-analyses of the six trials showed a statistically significant higher number of participants experiencing implant failures in the group not receiving antibiotics (RR 0.33; 95% CI 0.16 to 0.67, P value 0.002, heterogeneity: Tau(2) 0.00; Chi(2) 2.87, df = 5 (P value 0.57); I(2) 0%). The number needed to treat for one additional beneficial outcome (NNTB) to prevent one person having an implant failure is 25 (95% CI 14 to 100), based on an implant failure rate of 6% in participants not receiving antibiotics. There was borderline statistical significance for prosthesis failures (RR 0.44; 95% CI 0.19 to 1.00), with no statistically significant differences for infections (RR 0.69; 95% CI 0.36 to 1.35), or adverse events (RR 1; 95% CI 0.06 to 15.85) (only two minor adverse events were recorded, one in the placebo group). No conclusive information can be derived from the only trial that compared three different durations of antibiotic prophylaxis since no event (implant/prosthesis failures, infections or adverse events) occurred in any of the 25 participants included in each study group. There were no trials that evaluated different antibiotics or different antibiotic dosages.

AUTHORS' CONCLUSIONS: Scientific evidence suggests that, in general, antibiotics are beneficial for reducing failure of dental implants placed in ordinary conditions. Specifically 2 g or 3 g of amoxicillin given orally, as a single administration, one hour preoperatively significantly reduces failure of dental implants. No significant adverse events were reported. It might be sensible to suggest the use of a single dose of 2 g prophylactic amoxicillin prior to dental implant placement. It is still unknown whether postoperative antibiotics are beneficial, and which antibiotic is the most effective.

摘要

背景

部分牙种植失败可能归因于种植体植入时的细菌污染。生物材料周围的感染难以治疗,几乎所有受感染的种植体都必须移除。一般而言,手术中的抗生素预防仅适用于有感染性心内膜炎风险的患者;宿主反应降低时;在感染部位进行手术时;进行广泛且长时间的手术干预时;以及植入大型异物时。为尽量减少牙种植术后感染,已提出多种预防性全身抗生素治疗方案。最新方案建议,如果必须使用抗生素,应进行短期预防。抗生素给药可能会出现不良事件,范围从腹泻到危及生命的过敏反应。与抗生素广泛使用相关的另一个主要问题是抗生素耐药菌的产生。种植牙科中预防性使用抗生素存在争议。

目的

评估在牙种植时全身预防性使用抗生素与不使用抗生素或使用安慰剂相比的有益或有害影响,若抗生素有益,则确定哪种类型、剂量和疗程最有效。

检索方法

我们检索了Cochrane口腔健康组试验注册库(截至2013年6月17日)、Cochrane对照试验中央注册库(CENTRAL)(《Cochrane图书馆》2013年第5期)、通过OVID检索的MEDLINE(1946年至2013年6月17日)以及通过OVID检索的EMBASE(1980年至2013年6月17日)。电子数据库检索未设语言或日期限制。

选择标准

随机对照临床试验(RCT),随访至少三个月,比较各种预防性抗生素治疗方案与不使用抗生素对接受牙种植者的效果。结局指标包括假体失败、种植体失败、术后感染和不良事件(胃肠道、超敏反应等)。

数据收集与分析

由两位综述作者独立进行重复筛选符合条件的研究、评估试验偏倚风险和数据提取。结果以风险比(RRs)表示,采用随机效应模型分析二分结局,95%置信区间(CIs)。需调查包括临床和方法学因素在内的异质性。

主要结果

纳入6项RCT,共1162名参与者:3项试验比较术前2g阿莫西林与安慰剂(927名参与者),1项比较术前3g阿莫西林与安慰剂(55名参与者),1项比较术前1g阿莫西林加每日4次每次500mg共两天与不使用抗生素(80名参与者),1项比较四组:(1)术前2g阿莫西林;(2)术前2g阿莫西林加每日2次每次1g共七天;(3)术后1g阿莫西林每日2次共七天;(4)不使用抗生素(100名参与者)。整体证据质量被认为中等。六项试验的荟萃分析显示,未接受抗生素组的种植体失败参与者数量在统计学上显著更多(RR 0.33;95% CI 0.16至0.67,P值0.002,异质性:Tau(2) 0.00;Chi(2) 2.87,自由度 = 5(P值0.57);I(2) 0%)。基于未接受抗生素参与者6%的种植体失败率,预防一人发生种植体失败所需的额外有益结局治疗人数(NNTB)为25(95% CI 14至100)。假体失败有边缘统计学意义(RR 0.44;95% CI 0.19至1.00),感染(RR 0.69;95% CI 0.36至1.35)或不良事件(RR 1;95% CI 0.06至15.85)无统计学显著差异(仅记录到两例轻微不良事件,一例在安慰剂组)。比较三种不同抗生素预防疗程的唯一试验未得出确凿信息,因为每个研究组纳入的25名参与者中均未发生任何事件(种植体/假体失败、感染或不良事件)。没有试验评估不同抗生素或不同抗生素剂量。

作者结论

科学证据表明,一般而言,抗生素有利于减少在普通情况下植入牙种植体的失败。具体而言,术前一小时口服2g或3g阿莫西林单次给药可显著降低牙种植体失败率。未报告显著不良事件。建议在牙种植术前使用单剂量2g预防性阿莫西林可能是合理的。术后使用抗生素是否有益以及哪种抗生素最有效仍未知。

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Cochrane Database Syst Rev. 2013 Jul 31;2013(7):CD004152. doi: 10.1002/14651858.CD004152.pub4.
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本文引用的文献

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Effect of systemic antibiotics on clinical and patient-reported outcomes of implant therapy - a multicenter randomized controlled clinical trial.系统抗生素对种植体治疗的临床和患者报告结局的影响——一项多中心随机对照临床试验。
Clin Oral Implants Res. 2014 Feb;25(2):185-93. doi: 10.1111/clr.12098. Epub 2013 Jan 24.
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Effectiveness of prophylactic antibiotics at placement of dental implants: a pragmatic multicentre placebo-controlled randomised clinical trial.种植牙植入时预防性使用抗生素的有效性:一项实用的多中心安慰剂对照随机临床试验。
Eur J Oral Implantol. 2010 Summer;3(2):135-43.
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Does antibiotic prophylaxis at implant placement decrease early implant failures? A Cochrane systematic review.种植体植入时使用抗生素预防措施是否能降低早期种植体失败率?一项Cochrane系统评价。
Eur J Oral Implantol. 2010 Summer;3(2):101-10.
5
Interventions for replacing missing teeth: antibiotics at dental implant placement to prevent complications.缺失牙修复干预措施:种植牙植入时使用抗生素预防并发症。
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A pilot study to determine the effectiveness of different amoxicillin regimens in implant surgery.一项旨在确定不同阿莫西林治疗方案在种植手术中有效性的试点研究。
J Oral Implantol. 2011 Dec;37(6):691-6. doi: 10.1563/AAID-JOI-D-09-00134.1. Epub 2010 Jun 16.
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The efficacy of antibiotic prophylaxis at placement of dental implants: a Cochrane systematic review of randomised controlled clinical trials.牙种植体植入时抗生素预防的疗效:Cochrane对随机对照临床试验的系统评价
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Efficacy of prophylactic antibiotics for dental implants: a multicentre placebo-controlled randomised clinical trial.预防性抗生素用于牙种植体的疗效:一项多中心安慰剂对照随机临床试验。
Eur J Oral Implantol. 2008 Spring;1(1):23-31.
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A multicentre placebo-controlled randomised clinical trial of antibiotic prophylaxis for placement of single dental implants.单颗牙种植体植入抗生素预防的多中心安慰剂对照随机临床试验。
Eur J Oral Implantol. 2009 Winter;2(4):283-92.
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Interventions for replacing missing teeth: antibiotics at dental implant placement to prevent complications.缺失牙修复干预措施:种植牙植入时使用抗生素预防并发症。
Cochrane Database Syst Rev. 2008 Jul 16(3):CD004152. doi: 10.1002/14651858.CD004152.pub2.