老年人体药动学研究必要性分析

Analysis of the necessity of conducting pharmacokinetic study in the elderly

20世纪80年代初苯恶洛芬在英国及美国引发的致死性不良事件绝大多数发生于老年人群,这一事件的直接原因是老年人群药动学特殊性的忽视。人体药动学的研究对象应该能够代表临床实际应用人群。然而无论当时或是现在,老年人群的药动学研究数据都是严重缺失或不足的。尤其对于老年疾病的治疗药物,相关数据的缺失将限制其临床治疗,极易引发潜在的大范围安全性事件。随着人口老龄化进程的加速,监管机构、研发人员、临床医师和药师逐渐意识到老年人体药代研究的重要性和必要性。本文对老年人体药动学研究的现状和必要性加以分析,期望为药物的临床合理应用提供必需的数据支持。

The fatal adverse events caused by benoxaprofen in the 19~0s in the UK and the United States mostly occurred in the elderly. Ignoring the special pharmacokinetic property in the elderly population was the di rect cause of this event. The study object of clinical pharmacokinetics should represent the practical clinical popula tions. However, either in the past or present, the pharmacokinetic data in the elderly population was seriously inad equate or missing, especially for drugs targeting agerelated diseases. The lack of clinical research data in the elder ly population will limit the clinical treatment of the elderly population, and may easily lead to potential safety risks. With the acceleration of the process of population aging, regulators, sponsors, physicians and pharmacists come to re alize the importance and necessity of pharmacokinetic studies in the elderly. Understanding the pharmacokinetics of drugs in special populations such as the elderly can provide the necessary data to support rational drug therapy.