第1948期:Experts Say a Common Cold Medicine is Ineffective

American government experts who studied a popular medicine used for colds say the drug is likely not effective and should not be taken by mouth. Sixteen experts for the U.S. Food and Drug Administration examined the drug phenylephrine. The drug is in many medicines that treat nasal congestion, a condition also known as a stuffy nose. The medicines include Sudafed, Allegra and Dayquil among others. The experts read a scientific review released by the FDA before they met. The scientific study said there were many mistakes in earlier tests of phenylephrine’s effectiveness. It said the FDA no longer accepted the earlier testing results.研究一种用于治疗感冒的流行药物的美国政府专家表示，该药物可能无效，不应口服。美国食品和药物管理局的十六名专家检查了这种药物去氧肾上腺素。许多治疗鼻塞（也称为鼻塞）的药物中都含有这种药物。这些药物包括 Sudafed、Allegra 和 Dayquil 等。专家们在会面前阅读了 FDA 发布的科学评论。这项科学研究称，早期对去氧肾上腺素有效性的测试存在许多错误。据称，FDA 不再接受之前的检测结果。One of the experts was Dr. Mark Dykewicz. He is an allergy specialist at Saint Louis University School of Medicine. Dykewicz said, “Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine.” Phenylephrine is an over-the-counter drug. Anyone can buy it at a store. A doctor’s order is not required to purchase it. Phenylephrine is the most popular decongestant in a market valued at $2.2 billion dollars. If the FDA follows the advice of the experts, companies that make the medicine will have to remove it from stores. These companies include Johnson & Johnson, Bayer and other leading drug makers.Mark Dykewicz 博士就是其中一位专家。他是圣路易斯大学医学院的过敏专家。 Dykewicz 说：“现代研究，如果进行得当，并没有显示去氧肾上腺素对充血有任何改善。”去氧肾上腺素是一种非处方药。任何人都可以在商店购买。购买不需要医生的处方。去氧肾上腺素是市场价值 22 亿美元中最受欢迎的减充血剂。如果 FDA 听从专家的建议，生产该药物的公司将不得不将其从商店下架。这些公司包括强生公司、拜耳公司和其他领先的制药商。The drug would remain in medicines taken through the nose, however. The nasal spray form of phenylephrine is considered effective and there are no plans to review it. But offering higher amounts of the drug by mouth is not possible because it can increase blood pressure to dangerous levels. Researchers at the University of Florida first requested that the FDA remove phenylephrine from a list of approved drugs. The same researchers questioned the drug’s effectiveness in 2007. They said they found no difference between using the drug and using an inactive substance called a placebo.然而，这种药物将保留在通过鼻子服用的药物中。去氧肾上腺素鼻喷雾剂被认为是有效的，并且没有计划对其进行审查。但通过口服提供更高剂量的药物是不可能的，因为它会使血压升高到危险水平。佛罗里达大学的研究人员首先要求 FDA 将去氧肾上腺素从批准的药物清单中删除。同样的研究人员在 2007 年对该药物的有效性提出了质疑。他们表示，他们发现使用该药物和使用一种称为安慰剂的非活性物质没有区别。Phenylephrine has been sold in different forms for 75 years. Dr. Theresa Michele leads the FDA’s office of nonprescription drugs. She said, “Any time a product has been on the market that long, it’s human nature to make assumptions about what we know about the product.” The FDA reviewers said the studies they examined showed how quickly the body processes phenylephrine. The research shows that too little of the drug reaches the area of the nose when the medicine is taken by mouth. Forms of the drug sprayed into the nose appear more effective.去氧肾上腺素已以不同形式销售 75 年。 Theresa Michele 博士领导 FDA 非处方药办公室。她说：“任何时候，只要一种产品在市场上上市了这么长时间，我们就会对我们对该产品的了解做出假设，这是人类的本性。” FDA 审查人员表示，他们检查的研究表明身体处理去氧肾上腺素的速度有多快。研究表明，当口服药物时，到达鼻子区域的药物太少。喷入鼻子的药物形式似乎更有效。The reviewers said barring the drug from medicine taken by mouth would avoid the “unnecessary costs and delay in care of taking a drug that has no benefit. The FDA has not updated its list of approved drugs to treat nasal congestion since 1995. The process for changing the list takes years. But Congress passed a law in 2020 that would speed the process for drugs that do not require a doctor’s permission to use.审查人员表示，禁止口服该药物将避免“不必要的费用和延迟服用没有益处的药物。”自 1995 年以来，FDA 就没有更新过批准治疗鼻塞的药物清单。更改清单的过程需要数年时间。但国会在 2020 年通过了一项法律，将加快无需医生许可即可使用的药物的审批流程。