健康志愿者每周一次多奈哌齐透皮系统与口服多奈哌齐的生物等效性研究:通俗易懂的摘要。

IF 2.3 Q3 CLINICAL NEUROLOGY
Neurodegenerative disease management Pub Date : 2023-12-01 Epub Date: 2023-09-06 DOI:10.2217/nmt-2023-0012
Rene Braeckman, Charles Oh
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引用次数: 0

摘要

这是一篇发表在《阿尔茨海默病杂志》(Journal of Alzheimer's Disease)上的文章的简明摘要。它描述了一种贴在皮肤表面的粘合贴片,也称为透皮给药系统(或 TDS),可通过轻度、中度和重度阿尔茨海默型痴呆患者的皮肤给药多奈哌齐(今后称为多奈哌齐 TDS)。本摘要的重点是多奈哌齐通过皮肤进入人体的速度和剂量,以及它与口服药(口服多奈哌齐)的比较。本摘要还研究了使用每周一次的多奈哌齐 TDS 与每天一次的多奈哌齐药片相比,有多少多奈哌齐在体内循环。我们的研究表明,每周使用一次多奈哌齐 TDS 和每天口服一次多奈哌齐药片时,多奈哌齐在体内的循环量相同:痴呆症是一个术语,用来描述一个人的记忆、思考或决策能力下降,无法顺利完成日常活动。阿尔茨海默氏症是一种进展缓慢的疾病,痴呆症的症状会在多年后逐渐加重。在显微镜下观察,阿尔茨海默氏症在大脑中的明显特征是脑细胞之间出现称为斑块的蛋白质沉积,以及脑细胞内出现称为缠结的蛋白质链。在阿尔茨海默氏症患者的大脑中,有许多肉眼无法看到的特征,其中之一就是一种叫做乙酰胆碱的化学物质含量很低,而乙酰胆碱能让大脑中某些与记忆有关的神经细胞相互沟通。多奈哌齐是一种广泛用于治疗与阿尔茨海默病有关的痴呆症的药物,它能增加大脑中乙酰胆碱的含量。多奈哌齐通常为药丸状,口服。然而,口服多奈哌齐的一个问题是,它可能会引起腹泻、恶心和呕吐等胃肠道副作用。这些副作用可能会严重到人们停止服药。2022 年,美国食品和药物管理局首次批准了一种多奈哌齐 TDS,上市名称为 Adlarity。多奈哌齐 TDS 用于阿尔茨海默病引起的轻度、中度和重度痴呆患者。每周在患者背部、臀部上方或大腿皮肤上涂抹一次。多奈哌齐 TDS 允许药物多奈哌齐直接通过皮肤被人体吸收,这意味着药物不经过消化系统。结果如何?在健康的志愿者身上,我们发现多奈哌齐 TDS 进入人体的药量与口服多奈哌齐药片相似。这是通过一种称为药代动力学(多奈哌齐进入血液的量、速度和稳定性)的检查来实现的。在健康的参与者中,多奈哌齐 TDS 对胃肠的副作用(如便秘、腹泻、恶心和呕吐)总体上要少于口服多奈哌齐药片,不过与口服多奈哌齐药片相比,更多的参与者表示服用多奈哌齐 TDS 会出现腹痛。多奈哌齐 TDS 对神经系统的副作用(如头晕和嗜睡)也比口服多奈哌齐药片少。这些发现支持使用多奈哌齐 TDS 治疗阿尔茨海默病患者。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A study of once-a-week donepezil transdermal system's bioequivalence to oral donepezil in healthy volunteers: a plain language summary.

What is this summary about?: This is a plain language summary of an article published in the Journal of Alzheimer's Disease. It describes an adhesive patch placed on the skin's surface, also referred to as a transdermal delivery system (or TDS), that delivers donepezil (called donepezil TDS going forward) through the skin of patients with mild, moderate, and severe dementia of the Alzheimer's type. This summary focuses on how fast and how much of the medication donepezil enters the body through the skin, and how it compares with taking a pill form of donepezil by mouth (oral donepezil). This summary also looks at how much donepezil is circulating through the body with the use of the once-a-week donepezil TDS versus the once-a-day donepezil pill. We show that the same amount of donepezil circulates through the body when donepezil TDS is used once a week as when a participant takes an oral donepezil pill once a day.

Why is this study important?: Dementia is a term used to describe a person's decreasing ability to remember, think, or make decisions necessary to successfully complete daily activities. Alzheimer's disease is a disorder that progresses slowly, with the symptoms of dementia getting worse over many years. When viewed under a microscope, the visible features of Alzheimer's disease within the brain are protein deposits called plaques between brain cells and protein strands within brain cells that appear as tangles. One of the many features that cannot be seen with the naked eye in the Alzheimer's brain is the low level of a chemical called acetylcholine that allows certain nerve cells in the brain involved with memory to communicate with one another. Donepezil, a drug that is widely used to treat dementia associated with Alzheimer's disease, increases the amount of acetylcholine in the brain. Donepezil is usually in pill form and taken by mouth. However, one problem with taking oral donepezil is that it can cause stomach or intestinal side effects like diarrhea, nausea, and vomiting. These side effects may be bad enough that people stop taking their medication. In 2022, for the first time, the United States Food and Drug Administration approved a donepezil TDS marketed under the name Adlarity. Donepezil TDS is for use in patients who have mild, moderate, and severe dementia caused by Alzheimer's disease. It is applied once a week to skin on the patient's back, upper buttocks, or thigh. Donepezil TDS allows the drug donepezil to be absorbed into the body directly through the skin, which means that the drug does not go through the digestive system. This means that many stomach and intestinal side effects (the undesirable effects of the drug) can potentially be reduced.

What were the results?: In healthy volunteers, we showed that donepezil TDS allows a similar amount of the drug into the body as the oral donepezil pill. This is done using a type of examination known as pharmacokinetics (how much, how fast, and how steadily donepezil is taken into the bloodstream). In healthy participants, donepezil TDS had overall fewer stomach and intestinal side effects (like constipation, diarrhea, nausea, and vomiting) than the oral donepezil pill, although more participants reported abdominal pain with donepezil TDS than with oral donepezil. Donepezil TDS also had fewer instances of nervous system side effects (like dizziness and sleepiness) than the oral donepezil pill. These findings support using donepezil TDS to treat patients with Alzheimer's disease.

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