Howland Robert H
University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
J Psychosoc Nurs Ment Health Serv. 2011 Oct;49(10):13-5. doi: 10.3928/02793695-20110915-01. Epub 2011 Sep 28.
Establishing causality between a medication exposure and the development of an adverse event (AE) is a difficult process. If a causal relationship can be confirmed, an AE is referred to as an adverse drug reaction (ADR). The reported signs or symptoms of an AE could be due to the drug, the underlying disorder, or other unrelated or concurrent factors. The conventional approach to defining ADRs is based on a clinical judgment that the link between drug exposure and AE is definite, probable, possible, or doubtful. The validity and reliability of this assessment varies according to the knowledge, background, and experience of the clinician making the assessment. A systematic and validated method for estimating the probability of an ADR has been described by Naranjo et al. This method solicits answers to 10 questions; the total score is then used to quantify the probability of an ADR.
确定药物暴露与不良事件（AE）发生之间的因果关系是一个困难的过程。如果能够确认因果关系，则该AE被称为药物不良反应（ADR）。报告的AE体征或症状可能归因于药物、潜在疾病或其他不相关或并发因素。定义ADR的传统方法基于临床判断，即药物暴露与AE之间的关联是确定的、很可能的、可能的或可疑的。这种评估的有效性和可靠性因进行评估的临床医生的知识、背景和经验而异。Naranjo等人描述了一种用于估计ADR可能性的系统且经过验证的方法。该方法提出10个问题；然后将总分用于量化ADR的可能性。
