减缓认知衰退！Alzheimer’s新药被证有效！

译介 2023-06-20

收录于合集 #双语精选 46个

阿尔茨海默病（Alzheimer’s disease，简称AD），俗称“老年痴呆症”，一直威胁着全球数千万老年人的健康，也给患者及患者家属带来巨大的痛苦。如今，一种新药的出现，为他们带来了福音。

2022年9月28日，美国和日本两家制药公司宣布，由他们联合研发的新药成为首个明确能改善阿尔茨海默病症状的药物。这个药真有如此神奇的效果吗？我们一起看文章。

Alzheimer’s drug slows progression of cognitive decline in clinical trial, drugmakers say

制药商：临床试验发现阿尔茨海默病新药能减缓认知衰退

A monoclonal antibody treatment for Alzheimer’s disease called lecanemab slows the progression of cognitive decline by 27% compared with a placebo, drugmakers Biogen and Eisai said Tuesday.

日本制药公司卫材（Eisai）和美国生物技术巨头渤健（Biogen）在周二联合宣布，比起安慰剂，一种治疗阿尔茨海默病的单克隆抗体新药Lecanemab可以使患者认知能力下降的速度减缓27%。

The drug, tested in a Phase 3 global clinical trial, also met all secondary endpoints, showing “target engagement” with reduced amyloid levels – a protein that is one of the hallmarks of Alzheimer’s – and positive effects on cognition and the ability to perform everyday tasks when compared with a placebo.

该药物在经历了III期Clarity AD全球临床试验后，也达到了所有次要终点，。结果表明，该药表现出“靶向参与作用”，使得患者体内淀粉样蛋白水平降低。淀粉样蛋白是阿尔茨海默病的病理特征之一。同时，该药还表现出对患者的认知和执行日常任务的能力有积极影响。

“We believe that helping to alleviate these burdens will positively impact society as a whole,” Eisai CEO Haruo Naito said in a statement. “Additionally, the lecanemab Clarity AD study results prove the amyloid hypothesis, in which the abnormal accumulation of Aβ in the brain is one of the main causes of Alzheimer’s disease.”

“我们相信，帮助这些患者减轻负担将对整个社会产生积极的影响。”卫材首席执行官Haruo Naito在声明中说道：“另外，新药lecanemab 在Clarity AD的临床试验结果也能证明淀粉样蛋白导致阿尔茨海默病的假说，即大脑中Aβ淀粉样蛋白的沉积是导致阿尔茨海默病的主要原因之一。”

However, Dr. Richard Isaacson, director of the Alzheimer’s Prevention Clinic in the Center for Brain Health at Florida Atlantic University’s Schmidt College of Medicine, told CNN that the trial results are not proof of the amyloid hypothesis.

然而，佛罗里达大西洋大学（Florida Atlantic University）薛密特医学院（Schmidt College of Medicine）大脑健康中心阿尔茨海默病预防诊所主任理查德·艾萨克森博士告诉CNN，实验结果不一定能成为淀粉样蛋白假说的证据。

“It proves that, in people with a certain amount of amyloid in their brain at a certain stage of the disease, that this drug works. In terms of proving a mechanism by using a drug, no. Alzheimer’s is a very heterogeneous disease.”

他指出：“该实验结果证明，当患者处于疾病某一个阶段，且大脑内的淀粉样蛋白达到一定量时，该药才能起作用。但是通过使用药物来证明一种机制，这是不够的。阿尔茨海默病是一种异质性疾病。

But he says that does not diminish the potential significance of the trial.

不过他也说到，这并不会影响此次试验所带来的潜在意义。

“In the past, reducing amyloid in the brain has not always been tied to cognitive improvements or any meaningful clinical improvements. In this study, every endpoint was positive. That’s never happened before.”

“在过去，减少大脑中的淀粉样蛋白并不一定能与认知能力的改善或任何有意义的临床改善联系在一起。在这项研究中，每个结果都是积极的。这在以前从未发生过。”

About 2.8% of trial participants who took the drug had a symptomatic side effect called ARIA-E, swelling in the brain, but none of those taking the placebo did. The rate of symptomatic ARIA-H, brain bleeding and iron buildup in tissue, was 0.7% in the drug group and 0.2% in the placebo group.

大约2.8%服用该药物的试验参与者出现了一种叫做ARIA-E的症状性副作用（脑部发生肿胀），但服用安慰剂的试验参与者均未出现该副作用。ARIA-H症状性副作用（脑出血和组织中的铁积聚）在药物组的发生比率为0.7%，在安慰剂组中为0.2%。

Overall, there were ARIA side effects in 21.3% of the trial participants taking lecanemab, but Isaacson cautions that when people receive this type of treatment, they need to be monitored closely throughout the process. Symptomatic side effects are a more important measure, he says.

总的来说，在服用lecanemab的试验参与者中，有21.3%出现了ARIA副作用，但艾萨克森博士提醒，当人们接受这种类型的治疗时，他们需要在整个过程中受到密切监测。症状性副作用是更重要的衡量标准。

“When this drug is used correctly, the side effects are manageable, and the negative outcomes are preventable in most cases,” he said.

艾萨克森博士说道：“只要药物使用得当，那么副作用就是可控的，并且在大多数情况下，消极结果也是可以避免的。”

The Alzheimer’s Association expressed hope over the results.

美国阿尔茨海默病协会对新药试验结果表达了希望。

“For people in the earliest stages of Alzheimer’s, this treatment has the potential to change the course of the disease in a clinically meaningful way,” the association said in a statement. “These results indicate lecanamab may give people more time at or near their full abilities to participate in daily life, remain independent and make future health care decisions. Treatments that deliver these benefits to those with mild cognitive impairment (MCI) due to Alzheimer’s disease and early Alzheimer’s dementia are just as valuable as treatments that extend the lives of those with other terminal diseases.”

该协会在一项声明中表示：“对于阿尔茨海默病早期患者来说，这种治疗方法有可能以具有临床意义的方式改变疾病进程。这些试验结果表明，lecanamab药物能帮助患者有更多时间完全达到或接近达到参与日常生活、保持独立并做出未来医疗健康决定的能力。对早期阿尔茨海默病患者和由阿尔茨海默病导致的轻度认知障碍（MCI）患者来说，这种治疗方法带来的好处就像延长其他绝症患者生命的治疗方法一样有价值。

Isaacson agreed: “I’m envisioning a world where, in the years to come, this will, this type of treatment will be one of the many tools in our toolbox in the management of Alzheimer’s disease.”

艾萨克森博士赞同道：“我正在设想一个世界，在未来的几年里，这种治疗方法将成为我们治疗阿尔茨海默病的众多工具之一。”

Although the findings come from only preliminary data, the companies say they plan to publish them in a peer-reviewed journal and plan to present the data in order to seek approval from US regulatory authorities by the end of March.

尽管这些发现仅来自于初步数据，但这两家公司表示，他们计划在3月底前在同行评议期刊上发表研究结果并提交数据，希望获得美国监管机构对新药的批准。

Biogen is also the company behind another Alzheimer’s drug, Aduhelm, which was controversially approved by the FDA in June 2021. Aduhelm was the first new Alzheimer’s drug approved in nearly 20 years, but there were questions about its efficacy and cost. The FDA quickly narrowed the group of people who could receive it, and it’s unclear how many doctors will prescribe it because of uncertainty surrounding its results.

渤健公司还有一款治疗阿尔茨海默病的药物，叫做Aduhelm。该药在2021年6月由美国食品药品监督管理局（FDA）审批通过，却引发业内争议。Aduhelm是近20年来第一个被批准的阿尔茨海默病新药，但其疗效和成本仍然存疑。FDA很快就缩小该药的适用人群，而且由于其药效存在不确定性，目前还不清楚有多少医生会开这种药。

Aduhelm was also the driving force behind a massive increase in Medicare Part B premiums for 2022, and Medicare restricted coverage in April.

Aduhelm也是2022年美国医保Medicare Part B保费大幅增加的原因，而且4月份时该药的医疗保险覆盖受限。

今日词汇

Alzheimer’s / ˈæltsˈhaɪməz / 阿尔茨海默病

cognitive decline 认知衰退

clinical trial 临床试验

monoclonal antibody 单克隆抗体

endpoint n. 终点

target engagement 靶向参与作用

amyloid / ˈæmɪlɔɪd / n. 淀粉样蛋白

heterogeneous / ˌhetərəˈdʒiːniəs /

adj. 各种各样的；混杂的