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美国批准将一减肥药用于降低心脏病风险

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In 2021, the U.S. food and drug agency approved the drug Wegovy for weight loss.

2021 年,美国食品药品监督管理局批准了用于减肥的药物Wegovy。

Now, the Food and Drug Administration (or, FDA) says the drug can reduce the risk of death from stroke or heart attack in adults who have cardiovascular disease or are overweight.

现在,该机构表示,对于患有心血管疾病或超重的成年人,服用这种药物可以降低死于中风或心脏病发作的风险。

The FDA approved a usage change requested by drugmaker Novo Nordisk.

美国食品药品监督管理局批准了制药商诺和诺德(Novo Nordisk)提出的一项用途变更申请。

The change expands the use of semaglutide, the general or generic name of the drug.

这一变更扩大了semaglutide(该药的通用名称)的使用范围。

Wegovy is the brand name given by the company that sells it.

Wegovy是销售公司给该药物定的品牌名称。

The FDA based its decision on the results of a study that found Wegovy cut the risk of serious heart problems.

美国食品药品监督管理局的决定是基于一项研究结果,即Wegovy可降低出现严重心脏问题的风险。

The study also found that overweight patients with heart disease but not diabetes were 20 percent less likely to experience those problems.

该研究还发现,服用该药后,患有心脏病但未患糖尿病的超重患者出现严重心脏问题的可能性降低了20%。

Researchers compared the results of patients who took the drug with those who took a placebo, or inactive injections.

研究人员比较了服用这种药物的病人和服用安慰剂或非活性注射剂的病人的结果。

Wegovy is the first medication approved to help prevent possibly life-threatening disease in overweight people, the agency said.

该机构表示,Wegovy是首个获准用于帮助超重人群预防可能危及生命的疾病的药物。

Dr. John Sharretts directs the FDA's Division of Diabetes, Lipid Disorders, and Obesity.

约翰·沙雷茨(John Sharretts)博士是该机构糖尿病、血脂紊乱和肥胖症部门的负责人。

He said, "Providing a treatment option that is proven to lower this cardiovascular risk" is good for public health.

他说:“提供一种经证实能降低心血管疾病风险的治疗选择”对公众健康有益。

Dr. Martha Gulati said the decision will change the way many heart patients are treated.

玛莎·古拉蒂(Martha Gulati)博士说,美国食品药品监督管理局的这一决定将改变许多心脏病患者的治疗方式。

Gulati is a cardiologist at Cedars-Sinai Medical Center in Los Angeles.

古拉蒂是洛杉矶西达赛奈医疗中心的心脏病专家。

The research also confirms that the new class of obesity medications are useful for improving health, not just losing weight.

这项研究还证实,新型肥胖症药物有助于改善健康状况,而不仅仅是减轻体重。

"The hope is that insurers will start understanding that this is not a vanity drug," Gulati said.

古拉蒂说:“我们希望保险公司开始认识到,这不是一种虚荣药物。”

So-called vanity drugs are drugs that serve no medical purpose.

所谓“虚荣药物”是指不满足医疗用途的药物。

Some researchers call them "lifestyle" drugs.

一些研究人员称其为“生活方式”药物。

Gulati estimates that nearly 70 percent of her heart patients could be eligible for treatment.

古拉蒂估计,她的心脏病患者中,近70%都具备接受治疗的条件。

Wegovy is a high-dose version of the drug Ozempic.

Wegovy是药物Ozempic的高剂量版本。

Ozempic is a diabetes treatment.

Ozempic 是一种治疗糖尿病的药物。

The FDA approved the drug to cut the risk of serious heart problems in people with disease.

美国食品药品监督管理局批准将该药用于降低心脏病患者出现严重心脏问题的风险。

The weight-loss drug costs about $1,300 a month.

这种减肥药每月的价格约为1300美元。

Novo Nordisk has also asked European Union officials to expand the use of the drug for heart problems.

诺和诺德公司还请求欧盟官员扩大该药物使用范围,用于治疗心脏病。

The FDA warned that Wegovy carries the risk of serious side effects.

美国食品药品监督管理局警告说,Wegovy可能产生严重的副作用。

These included thyroid tumors and certain cancers.

这些副作用包括引发甲状腺肿瘤和某些癌症。

Other possible side effects can include low blood sugar.

其他可能的副作用还包括引发低血糖。

Organs in the body can be affected such as the pancreas, gallbladder, kidney, or eye.

体内器官可能受到影响,如胰腺、胆囊、肾脏或眼睛。

Another possible side effect is suicidal behavior or thinking.

还有一种可能的副作用是引发自杀行为或想法。

The clinical trial, which resulted in the drug's approval, involved more than 17,600 people.

促成该药物获得批准的临床试验涉及 17600 多人。

About one third of them reported serious side effects.

其中约三分之一的人报告了严重的副作用。

About 17 percent of the group that took Wegovy and about eight percent of those who received a placebo left the study because of reported side effects.

约有17%服用了Wegovy的人和8%服用了安慰剂的人因报告的副作用而退出研究。

The new approval could mean that Medicare might increase coverage to the drug.

这一新批准可能意味着医疗保险(Medicare)会将该药物纳入覆盖范围。

Medicare is the federal health coverage program for retirement-aged citizens.

医疗保险是针对退休公民的联邦医疗保险项目。

U.S. law bars Medicare from covering drugs for weight loss alone.

美国法律禁止联邦医疗保险承保单一用途的减肥药物。

Recent estimates say nearly $3 billion was spent in 2021 covering Ozempic to treat diabetes.

据最近的估计,2021年,为将用于治疗糖尿病的Ozempic纳入保险,花费了近30亿美元。

Tricia Neuman is a Medicare expert at KFF, a nonprofit organization based in San Francisco that researches health policy.

特里西娅·纽曼(Tricia Neuman)是旧金山一家研究医疗政策的非营利组织KFF的医疗保险专家。

She said the change "... will open the door to allow more people on Medicare to gain access to Wegovy."

她说,这一变化“......将为更多的医疗保险患者获得Wegovy打开大门。”

A spokesperson for the industry group America's Health Insurance Plans said private health coverage companies will consider the new guidance for Wegovy.

行业组织“美国健康保险计划”(America's Health Insurance Plans)的一位发言人说,私营医疗保险公司将考虑为Wegovy提供新的指导。

Drugmakers and activists for lower obesity rates have been pushing for expanded coverage.

药品制造商和呼吁降低肥胖率的活动家一直在推动扩大保险的覆盖范围。

This includes legislation that would require Medicare to pay for the obesity drug.

这包括通过立法让医疗保险覆盖减肥药物的费用。

The cost of the drug needs to be balanced by reduced spending on medical care related to obesity and heart disease.

药物成本需要通过减少与肥胖症和心脏病有关的医疗支出来平衡。

Another problem is a limited supply of the drug.

另一个问题是药物供应有限。

The FDA said there has been a shortage for more than a year.

美国食品药品监督管理局表示,这种药物的短缺已经持续了一年多。

Novo Nordisk officials said they are aiming to increase production.

诺和诺德公司的高级职员表示,他们正致力于提高产量。

For Gulati, the heart specialist, wider use cannot come soon enough.

对于心脏专家古拉蒂来说,扩大这种药物的使用范围已经刻不容缓。

"Everybody (is) waiting to get this medication," she said.

她说:“每个人都在等着获得这种药物。”

"Lower the cost, do (not) be greedy and make sure the drug is available for use."

“降低成本,(不要)贪婪,确保有药物可以使用”。

And that's the Health & Lifestyle report. I'm Anna Matteo.

以上就是《健康与生活方式》的报道。我是安娜·马蒂奥。

译文为可可英语翻译,未经授权请勿转载!

重点单词   查看全部解释    
cardiologist

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n. 心脏病学家;心脏病科医师

 
option ['ɔpʃən]

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n. 选择权,可选物,优先购买权
v. 给予选

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diabetes [.daiə'bi:ti:z]

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n. 糖尿病

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plastic ['plæstik, plɑ:stik]

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adj. 塑料的,可塑的,造型的,整形的,易受影响的

 
brand [brænd]

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n. 商标,牌子,烙印,标记
vt. 打烙印,

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supply [sə'plai]

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n. 补给,供给,供应,贮备
vt. 补给,供

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affect [ə'fekt]

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vt. 影响,作用,感动

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artery ['ɑ:təri]

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n. 动脉,主流,干道

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placebo [plə'si:bəu]

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n. 安慰剂,安慰话

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administration [əd.mini'streiʃən]

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n. 行政,管理,行政部门

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