Whitehouse P J
Alzheimer Center, University Hospitals of Cleveland, Case Western Reserve University, Ohio 44106, USA.
Acta Neurol Scand Suppl. 1996;165:145-9. doi: 10.1111/j.1600-0404.1996.tb05885.x.
In addition to being driven by basic scientific research and the preclinical and clinical evaluation of promising new compounds, the development of drugs for patients with Alzheimer's disease (AD) must also be guided by public policy and ethical considerations. More carefully coordinated efforts should be devoted to reducing caregiver burden and providing community-based health care services for patients with chronic as opposed to acute diseases. Important ethical issues include the appropriate duration of double-blind, placebo-controlled clinical trials, the determination of the meaning of "informed consent" when dealing with patients with dementia, the establishment of outcome goals for various stages of the disease process, and the provision of appropriate hospice-type care. The establishment of the International Working Group on Harmonization of Dementia Drug Guidelines is an important step in the process of achieving an international approach toward the development and evaluation of drugs for patients with AD.
除了受到基础科学研究以及对有前景的新化合物进行临床前和临床评估的推动外，阿尔茨海默病（AD）患者用药的研发还必须以公共政策和伦理考量为导向。应更加精心地协调各方努力，以减轻照护者负担，并为慢性病而非急性病患者提供基于社区的医疗服务。重要的伦理问题包括双盲、安慰剂对照临床试验的适当持续时间、在应对痴呆症患者时对“知情同意”含义的判定、确定疾病进程各阶段的结局目标，以及提供适当的临终关怀式护理。成立痴呆症药物指南协调国际工作组是在实现针对AD患者药物研发和评估的国际方法进程中的重要一步。
