Bach David S
University of Michigan, Ann Arbor, Michigan, USA.
Methodist Debakey Cardiovasc J. 2010;6(4):48-52. doi: 10.14797/mdcj-6-4-48.
Beginning in 1955, the American Heart Association recommended antibiotic prophylaxis among patients with certain structural heart diseases to decrease the likelihood of infective endocarditis (IE) following dental procedures. Over the ensuing 52 years, the American College of Cardiology/American Heart Association (ACC/AHA) guidelines were revised to address gastrointestinal and genitourinary procedures and to modify the assessment of relative risks and specific regimens for prophylaxis. Throughout the various revisions, prophylaxis was recommended for individuals who were at increased risk of developing IE based on best evidence and consensus opinion, albeit in the absence of randomized controlled trials. In 2007, the AHA published a revised guideline statement dramatically restricting its recommendations for antibiotic prophylaxis against IE. In 2008, these views were incorporated in an ACC/AHA guideline update on the management of patients with heart valve disease. The revisions represent a dramatic shift in terms of the patients for whom antibiotic prophylaxis is recommended and the procedures for which it is recommended. What is striking about the new guidelines is that the change in recommendations was based not on new data, but on a change in philosophy despite the lack of new data. To some degree, the arguments for and against antibiotic prophylaxis become those of philosophy, ethics, and the role of evidence-based medicine. This manuscript attempts to briefly examine those arguments and discuss why the revised guidelines may fail to respect the ethical principles of beneficence and patient autonomy.
从1955年开始,美国心脏协会建议某些患有结构性心脏病的患者进行抗生素预防,以降低牙科手术后感染性心内膜炎(IE)的发生可能性。在随后的52年里,美国心脏病学会/美国心脏协会(ACC/AHA)指南不断修订,以涵盖胃肠道和泌尿生殖系统手术,并对预防的相对风险评估和具体方案进行调整。在历次修订过程中,尽管缺乏随机对照试验,但基于最佳证据和共识意见,仍建议对发生IE风险增加的个体进行预防。2007年,美国心脏协会发布了一份修订后的指南声明,大幅限制了其针对IE的抗生素预防建议。2008年,这些观点被纳入ACC/AHA关于心脏瓣膜病患者管理的指南更新中。这些修订在推荐进行抗生素预防的患者以及推荐进行预防的手术方面都代表了巨大转变。新指南令人惊讶的是,推荐的改变并非基于新数据,而是在缺乏新数据的情况下基于理念的转变。在某种程度上,支持和反对抗生素预防的争论变成了关于理念、伦理以及循证医学作用的争论。本手稿试图简要审视这些争论,并讨论修订后的指南为何可能未能尊重有益和患者自主的伦理原则。