Clinical importance of drug-drug-interactions

药物相互作用的临床重要性

• 批准号: 7032605
• 负责人: Sean Hennessy
• 金额: $ 47.44万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-15 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7032605
• 关键词: Medicare /Medicaid; aging; behavioral /social science research tag; chemotherapy; clinical research; disease /disorder proneness /risk; drug adverse effect; drug interactions; geriatrics; health services research tag; human data; human morbidity; human mortality; iatrogenic disease; medical records; patient safety /medical error; pharmacokinetics; statistics /biometry

DESCRIPTION (provided by applicant): Drug-drug interactions (DDIs) are an important public health problem, especially in the elderly, who are the largest consumers of medications. Nearly all existing knowledge about the clinical importance of potential DDIs comes from pharmacokinetic studies or case reports, both of which have limited utility for identifying clinically important DDIs. As a result, there is a great deal of disagreement among standard DDI reference texts regarding the clinical importance of most potential DDIs. Systematic efforts such as drug utilization review programs and computerized physician order entry that seek to improve medication use depend entirely upon a valid set of clinical rules, and are thus severely hampered by this knowledge gap. To address these critical gaps in existing knowledge of the clinical importance of DDIs, the investigators will perform controlled epidemiologic studies of high-priority potential DDIs that have been selected based on a formal process involving consultation with an Expert Panel of clinicians and clinical pharmacologists. We will use and expand upon an existing, very large pharmacoepidemiologic database consisting of Medicaid data from five large programs, supplemented by Medicare data to ensure complete capture of outcomes in the elderly, together with the General Practice Research Database from the UK. We will examine the validity of our outcome measures using medical record review. Our research strategy will include nested case-control and case-crossover designs, and will yield relative risks, risk differences, and number needed to harm (NNH). Patient and treatment factors associated with developing the adverse outcome of interest will be studied. The results of this study will have important implications for public health, clinical care, and the elucidation of the pharmacology of DDIs, and will serve as a basis for future studies examining factors not recorded in administrative and medical records data.

描述（由申请人提供）：药物相互作用（DDI）是一个重要的公共卫生问题，特别是对于老年人来说，他们是药物的最大消费者。几乎所有关于潜在 DDI 的临床重要性的现有知识都来自药代动力学研究或病例报告，这两者对于识别临床上重要的 DDI 的作用有限。因此，标准 DDI 参考文本对于大多数潜在 DDI 的临床重要性存在很大分歧。寻求改善药物使用的系统性努力，例如药物使用审查计划和计算机化医嘱输入，完全依赖于一套有效的临床规则，因此受到这种知识差距的严重阻碍。为了解决 DDI 临床重要性现有知识中的这些关键差距，研究人员将对高优先级潜在 DDI 进行受控流行病学研究，这些研究是根据涉及临床医生和临床药理学家专家小组咨询的正式程序选择的。我们将使用并扩展现有的非常大的药物流行病学数据库，该数据库由来自五个大型计划的医疗补助数据组成，并辅以医疗保险数据，以确保完整捕获老年人的结果，以及英国的全科实践研究数据库。我们将通过病历审查来检查我们的结果测量的有效性。我们的研究策略将包括嵌套病例对照和病例交叉设计，并将产生相对风险、风险差异和造成伤害所需的数量（NNH）。将研究与产生感兴趣的不良结果相关的患者和治疗因素。这项研究的结果将对公共卫生、临床护理和 DDI 药理学的阐明产生重要影响，并将作为未来研究检查行政和医疗记录数据中未记录因素的基础。