Abstract：
Myocarditis and/or pericarditis (also known as myopericarditis) are inflammatory diseases involving the myocardium (with non-ischemic myocyte necrosis) and/or the pericardial sac. Myocarditis/pericarditis (MPC) may present with variable clinical signs, symptoms, etiologies and outcomes, including acute heart failure, sudden death, and chronic dilated cardiomyopathy. Possible undiagnosed and/or subclinical acute myocarditis, with undefined potential for delayed manifestations, presents further challenges for diagnosing an acute disease and may go undetected in the setting of infection as well as adverse drug/vaccine reactions. The most common causes of MPC are viral, with non-infectious, drug/vaccine associated hypersensitivity and/or autoimmune causes being less well defined and with potentially different inflammatory mechanisms and treatment responses. Potential cardiac adverse events following immunization (AEFIs) encompass a larger scope of diagnoses such as triggering or exacerbating ischemic cardiac events, cardiomyopathy with potential heart failure, arrhythmias and sudden death. The current published experience does not support a potential causal association with vaccines based on epidemiologic evidence of relative risk increases compared with background unvaccinated incidence. The only evidence supporting a possible causal association of MPC with a vaccine comes from case reports. Hypersensitivity MPC as a drug/vaccine induced cardiac adverse event has long been a concern for post-licensure safety surveillance, as well as safety data submission for licensure. Other cardiac adverse events, such as dilated cardiomyopathy, were also defined in the CDC definitions for adverse events after smallpox vaccination in 2006. In addition, several groups have attempted to develop and improve the definition and adjudication of post-vaccination cardiovascular events. We developed the current case definitions for myocarditis and pericarditis as an AEFI building on experience and lessons learnt, as well as a comprehensive literature review. Considerations of other etiologies and causal relationships are outside the scope of this document.
摘要：
心肌炎和/或心包炎(也称为心肌心包炎)是涉及心肌(具有非缺血性心肌细胞坏死)和/或心包囊的炎性疾病。心肌炎/心包炎（MPC）可能存在各种临床体征，症状,病因和结果，包括急性心力衰竭,猝死,和慢性扩张型心肌病.可能未诊断和/或亚临床急性心肌炎，具有不确定的延迟表现潜力，对诊断急性疾病提出了进一步的挑战，并且在感染以及不良药物/疫苗反应的情况下可能未被发现。MPC的最常见原因是病毒，非传染性的，药物/疫苗相关的超敏反应和/或自身免疫原因不太明确，并且具有潜在不同的炎症机制和治疗反应。免疫接种后的潜在心脏不良事件（AEFI）包括更大范围的诊断，如引发或加剧缺血性心脏事件，有潜在心力衰竭的心肌病,心律失常和猝死。目前发表的经验不支持与疫苗的潜在因果关系，基于流行病学证据的相对风险增加，与未接种疫苗的背景发生率相比。支持MPC与疫苗之间可能存在因果关系的唯一证据来自病例报告。作为药物/疫苗引起的心脏不良事件的超敏反应MPC长期以来一直是执照后安全性监测的关注，以及提交许可证的安全数据。其他心脏不良事件，比如扩张型心肌病,在2006年CDC对天花疫苗接种后不良事件的定义中也有定义.此外,一些研究小组试图发展和改进疫苗接种后心血管事件的定义和判定.我们开发了心肌炎和心包炎的当前病例定义，作为AEFI的经验和教训，以及全面的文献综述。其他病因和因果关系的考虑不在本文件的范围之内。
