A Before and After Study of the Effect of Ceasing to Give Antibiotic Prophylaxis

停止给予抗生素预防效果的前后研究

• 批准号: 8423913
• 负责人: MARTIN H THORNHILL
• 金额: $ 10.8万
• 依托单位: UNIVERSITY OF SHEFFIELD
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-18 至 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8423913
• 关键词: Admission activity; Adverse reactions; American Heart Association; Antibiotic Prophylaxis; Antibiotic Resistance; Antibiotics; Bacteremia; Blood Circulation; Cardiovascular system; Categories; Cessation of life; Clinical; Clinical Trials; Data; Death Rate; Dental; Dental Care; Development; Disease; Eating; Guidelines; Heart Valve Prosthesis; Heart Valves; Hospitals; Incidence; Infection; Infective endocarditis; Length of Stay; Link; Methods; Oral; Oral cavity; Organism; Patients; Placebos; Prevention; Public Health; Randomized Controlled Trials; Recommendation; Recording of previous events; Risk; Solid; Toothbrushing; United Kingdom; United States National Institutes of Health; clinical practice; evidence base; falls; high risk; killings; mortality; prevent; public health relevance; standard of care; statistics; toothbrush

DESCRIPTION (provided by applicant): Infective endocarditis (IE) is an infection of the heart valves, most often caused by circulating bacteria (bacteremia). There are ~27,000 cases a year in the USA and it is associated with high mortality (~30% within the first year) and serious long-term complications. Oral bacteria are implicated in 35-45% of IE cases. It is well documented that bacteremia occur during eating, tooth-brushing and invasive dental procedures. Because of this, the American Heart Association (AHA) guideline committee recommends that patients at highest risk from developing IE should be given antibiotic prophylaxis (AP) before invasive dental procedures, with the aim of killing bacteria that enter the circulation. Most cardiovascular guidelines committees around the world recommend AP for these people. However, there has never been a clinical trial of AP and there is a lack of scientific evidence to support the practic of giving AP. In the UK, AP was the 'standard of care' until March 2008 when the National Institute for Health and Clinical Excellence (NICE) introduced new guidelines recommending the complete cessation of AP prescribing in the UK. Since then the 'standard of care' has been NOT to prescribe AP prior to dental procedures. Objectives: To determine the efficacy of AP in preventing IE by performing a before and after study comparing the incidence of IE when AP was the 'standard of care' in the UK (before March 2008) with the incidence of IE when the 'standard of care' was NOT to give AP (after March 2008). Specific Aims: To perform a before and after study of the impact of the recommendation in the UK to stop giving AP, prior to invasive dental procedures, on the incidence of IE. Methods: We will: (1) Analyze National Prescribing data to determine the level of AP prescribing prior to and in the 4 years after the introduction of the NICE guidelines. (2) Analyze national Hospital Episode Statistics (HES) data to determine the incidence of IE prior to and in the 4 years after the introduction of the NICE guidelines. (3) Analyze links between HES data and Office of National Statistics data to determine the incidence of IE related mortality, during the hospital stay to treat IE and within 90 days of hospital admission, before and after the introduction of the NICE guidelines. (5) In addition, we will do the following sub-analysis of the IE incidence and mortality data: (a) In orde to more directly assess the benefit of AP in preventing IE caused by oral bacteria, we will determine the incidence of IE and IE related mortality for those patients where the causal organism was recorded as being of oral origin. (b) To more directly evaluate the potential benefit of the current AHA guidelines, we will also determine the incidence of IE and IE related mortality in those patients with a pre-existing prosthetic heart valve or previous history of IE, and who therefore fall into the AHA 'High-Risk' category indicated to receive AP under the current AHA guidelines.

描述（由申请人提供）：感染性心内膜炎（IE）是心脏瓣膜的感染，最常由循环细菌（菌血症）引起。美国每年约有 27,000 例病例，并且与高死亡率（第一年内约 30%）和严重的长期并发症相关。 35-45% 的 IE 病例与口腔细菌有关。有充分证据表明，菌血症发生在进食、刷牙和侵入性牙科手术过程中。因此，美国心脏协会 (AHA) 指南委员会建议，患 IE 风险最高的患者应在侵入性牙科手术前接受抗生素预防 (AP)，目的是杀死进入循环系统的细菌。大多数心血管 世界各地的指导委员会向这些人推荐 AP。然而，从未有过AP的临床试验，也缺乏科学证据支持给予AP的做法。在英国，AP 一直是“护理标准”，直到 2008 年 3 月，国家健康与临床卓越研究所 (NICE) 推出了新指南，建议在英国完全停止使用 AP 处方。从那时起，“护理标准”就不再是在牙科手术之前开 AP 处方。目的：通过进行一项前后研究，比较 AP 为英国“护理标准”（2008 年 3 月之前）时 IE 的发生率与“标准护理”时 IE 的发生率，以确定 AP 在预防 IE 方面的功效。 “照顾”不是给予 AP（2008 年 3 月之后）。具体目标：对英国建议在侵入性牙科手术前停止给予 AP 的建议对 IE 发生率的影响进行前后研究。方法：我们将： (1) 分析国家处方数据，以确定 NICE 指南引入之前和之后 4 年的 AP 处方水平。 (2) 分析国家医院发病统计 (HES) 数据，以确定 NICE 指南推出之前和之后 4 年的 IE 发病率。 (3) 分析 HES 数据与国家统计局数据之间的联系，以确定 IE 住院治疗期间和 90 年内 IE 相关死亡率的发生率 NICE 指南出台之前和之后的入院天数。 (5) 此外，我们将对 IE 的发病率和死亡率数据进行以下亚分析： (a) 为了更直接地评估 AP 在预防口腔细菌引起的 IE 方面的益处，我们将确定 IE 的发病率以及那些病原微生物被记录为口腔来源的患者的 IE 相关死亡率。 (b) 为了更直接地评估当前 AHA 指南的潜在益处，我们还将确定那些预先存在人工心脏瓣膜或既往有 IE 病史的患者的 IE 发生率和 IE 相关死亡率，因此属于AHA“高风险”类别表明根据当前的 AHA 指南接受 AP。