Scottish Dental Clinical Effectiveness Programme, NHS Education for Scotland, Dundee, UK.
Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.
Cochrane Database Syst Rev. 2022 May 10;5(5):CD003813. doi: 10.1002/14651858.CD003813.pub5.
Infective endocarditis is a severe infection arising in the lining of the chambers of the heart. It can be caused by fungi, but most often is caused by bacteria. Many dental procedures cause bacteraemia, which could lead to bacterial endocarditis in a small proportion of people. The incidence of bacterial endocarditis is low, but it has a high mortality rate. Guidelines in many countries have recommended that antibiotics be administered to people at high risk of endocarditis prior to invasive dental procedures. However, guidance by the National Institute for Health and Care Excellence (NICE) in England and Wales states that antibiotic prophylaxis against infective endocarditis is not recommended routinely for people undergoing dental procedures. This is an update of a review that we first conducted in 2004 and last updated in 2013.
Primary objective To determine whether prophylactic antibiotic administration, compared to no antibiotic administration or placebo, before invasive dental procedures in people at risk or at high risk of bacterial endocarditis, influences mortality, serious illness or the incidence of endocarditis. Secondary objectives To determine whether the effect of dental antibiotic prophylaxis differs in people with different cardiac conditions predisposing them to increased risk of endocarditis, and in people undergoing different high risk dental procedures. Harms Had we foundno evidence from randomised controlled trials or cohort studies on whether prophylactic antibiotics affected mortality or serious illness, and we had found evidence from these or case-control studies suggesting that prophylaxis with antibiotics reduced the incidence of endocarditis, then we would also have assessed whether the harms of prophylaxis with single antibiotic doses, such as with penicillin (amoxicillin 2 g or 3 g) before invasive dental procedures, compared with no antibiotic or placebo, equalled the benefits in prevention of endocarditis in people at high risk of this disease.
An information specialist searched four bibliographic databases up to 10 May 2021 and used additional search methods to identify published, unpublished and ongoing studies SELECTION CRITERIA: Due to the low incidence of bacterial endocarditis, we anticipated that few if any trials would be located. For this reason, we included cohort and case-control studies with suitably matched control or comparison groups. The intervention was antibiotic prophylaxis, compared to no antibiotic prophylaxis or placebo, before a dental procedure in people with an increased risk of bacterial endocarditis. Cohort studies would need to follow at-risk individuals and assess outcomes following any invasive dental procedures, grouping participants according to whether or not they had received prophylaxis. Case-control studies would need to match people who had developed endocarditis after undergoing an invasive dental procedure (and who were known to be at increased risk before undergoing the procedure) with those at similar risk who had not developed endocarditis. Our outcomes of interest were mortality or serious adverse events requiring hospital admission; development of endocarditis following any dental procedure in a defined time period; development of endocarditis due to other non-dental causes; any recorded adverse effects of the antibiotics; and the cost of antibiotic provision compared to that of caring for patients who developed endocarditis.
Two review authors independently screened search records, selected studies for inclusion, assessed the risk of bias in the included study and extracted data from the included study. As an author team, we judged the certainty of the evidence identified for the main comparison and key outcomes using GRADE criteria. We presented the main results in a summary of findings table.
Our new search did not find any new studies for inclusion since the last version of the review in 2013. No randomised controlled trials (RCTs), controlled clinical trials (CCTs) or cohort studies were included in the previous versions of the review, but one case-control study met the inclusion criteria. The trial authors collected information on 48 people who had contracted bacterial endocarditis over a specific two-year period and had undergone a medical or dental procedure with an indication for prophylaxis within the past 180 days. These people were matched to a similar group of people who had not contracted bacterial endocarditis. All study participants had undergone an invasive medical or dental procedure. The two groups were compared to establish whether those who had received preventive antibiotics (penicillin) were less likely to have developed endocarditis. The authors found no significant effect of penicillin prophylaxis on the incidence of endocarditis. No data on other outcomes were reported. The level of certainty we have about the evidence is very low.
AUTHORS' CONCLUSIONS: There remains no clear evidence about whether antibiotic prophylaxis is effective or ineffective against bacterial endocarditis in at-risk people who are about to undergo an invasive dental procedure. We cannot determine whether the potential harms and costs of antibiotic administration outweigh any beneficial effect. Ethically, practitioners should discuss the potential benefits and harms of antibiotic prophylaxis with their patients before a decision is made about administration.
感染性心内膜炎是一种发生在心脏腔室衬里的严重感染。它可以由真菌引起,但最常见的是由细菌引起。许多牙科手术都会引起菌血症,这可能导致少数人发生细菌性心内膜炎。细菌性心内膜炎的发病率较低,但死亡率较高。许多国家的指南都建议,在进行有创性牙科手术之前,对心内膜炎高危人群使用抗生素。然而,英格兰和威尔士国家卫生与保健卓越研究所(NICE)的指南指出,对于接受牙科手术的人,常规使用抗生素预防感染性心内膜炎并不推荐。这是我们于 2004 年首次进行的审查的更新,最后一次更新于 2013 年。
主要目的是确定在有细菌性心内膜炎风险或高危人群中,在有创性牙科手术前使用抗生素预防治疗,与不使用抗生素或安慰剂相比,是否会影响死亡率、严重疾病或心内膜炎的发生率。次要目的是确定在具有不同易患心内膜炎风险的心脏疾病患者和接受不同高风险牙科手术的患者中,牙科抗生素预防治疗的效果是否不同。危害:如果我们没有从随机对照试验或队列研究中发现抗生素预防治疗是否影响死亡率或严重疾病的证据,并且我们从这些研究或病例对照研究中发现了证据,表明抗生素预防治疗可以降低高危人群心内膜炎的发生率,那么我们还将评估在高风险牙科手术前单次使用抗生素(如青霉素[阿莫西林 2 克或 3 克])的预防治疗的危害是否等于预防这种疾病在心内膜炎高危人群中的益处。
一名信息专家检索了四个文献数据库,截至 2021 年 5 月 10 日,并使用了其他搜索方法来确定已发表、未发表和正在进行的研究。
由于细菌性心内膜炎的发病率较低,预计几乎找不到任何试验。因此,我们纳入了队列研究和病例对照研究,这些研究具有适当匹配的对照组或比较组。干预措施是在有细菌性心内膜炎风险的人群中,在有创性牙科手术前使用抗生素预防治疗,与不使用抗生素预防治疗或安慰剂相比。队列研究需要随访有风险的个体,并在任何有创性牙科手术后评估结局,根据是否接受预防治疗对参与者进行分组。病例对照研究需要将接受有创性牙科手术后发生心内膜炎的患者(已知在接受手术前有较高风险)与未发生心内膜炎的风险相似的患者进行匹配。我们感兴趣的结果是任何牙科手术后的死亡率或需要住院的严重不良事件;在规定的时间内因任何牙科手术导致的心内膜炎的发生;因其他非牙科原因导致的心内膜炎;抗生素的任何记录不良影响;以及与治疗发生心内膜炎的患者相比,提供抗生素治疗的成本。
两名综述作者独立筛选检索记录,选择纳入的研究,评估纳入研究的偏倚风险,并从纳入的研究中提取数据。作为一个作者团队,我们使用 GRADE 标准评估了主要比较和关键结局的证据确定性。我们在一个总结表中呈现了主要结果。
我们的新搜索自 2013 年上次审查以来没有发现任何新的研究纳入。以前的版本中没有包括随机对照试验(RCT)、对照临床试验(CCT)或队列研究,但有一项病例对照研究符合纳入标准。试验作者收集了在特定的两年期间内患有细菌性心内膜炎并在过去 180 天内接受过有预防用药指征的医学或牙科手术的 48 名患者的信息。这些患者与没有患细菌性心内膜炎的类似患者相匹配。所有研究参与者都接受了有创性的医学或牙科手术。两组患者进行了比较,以确定接受预防性抗生素(青霉素)治疗的患者是否不太可能发生心内膜炎。作者发现,青霉素预防治疗对心内膜炎的发生率没有显著影响。没有报告其他结果的数据。我们对证据的确定性水平非常低。
仍然没有明确的证据表明,在即将接受有创性牙科手术的高危人群中,抗生素预防治疗对细菌性心内膜炎是否有效或无效。我们无法确定抗生素给药的潜在危害和成本是否超过任何有益效果。从伦理上讲,在决定给药之前,医生应该与患者讨论抗生素预防治疗的潜在益处和危害。