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作者：未知 来自：路透社 发布时间：2004-3-30 |
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 一个美国顾问小组3月25日表示，支持使用一种注射药物来修复某些爱滋病毒（HIV）感染者受损的脸部，但他们也警告，这种疗法不应普遍用于美容辅助。虽然顾问小组一致同意推荐以上述药物治疗患有脸部损毁症（face-wasting disease）的HIV病人，但也同时向美国食品和药物管理局（FDA）建议，应当采取措施限制这种产品的使用。FDA通常会采纳专家顾问小组的建议。Aventis的子公司Dermik Laboratories正在设法让这种名为Sculptra的药物得到有限的核准，但有些专家认为，这种合成聚合物可能会成为广受欢迎的抗皱纹产品。用于治疗HIV的抗逆转录病毒药物（antiretroviral drug）也会导致面部脂肪流失，进而造成深深的皱纹和面颊深陷。试用过Sculptra的HIV患者透过顾问小组要求FDA尽快核准这种产品。他们表示，Sculptra挽救了他们的尊严，让他们免于走上自杀之途。在欧洲，Sculptra已经作为治疗皱纹的药物上市，其商品名为New-Fill，目前已行销30多个国家。不过，顾问小组成员表示，如果美国医生想让非HIV患者使用这种药物，必须认真考虑。他们还呼吁在药品标签上加上明显的警告。 Wrinkle Filler Only for HIV Patients, FDA Panel SaysThu Mar 25, 2004 06:22 PM ETGAITHERSBURG, Md. (Reuters) - A U.S. advisory panel on Thursday backed an injectable treatment that helps restore the disfigured faces of some HIV patients, but warned against its use as a general beauty aid. While the panel unanimously voted to recommend what could become the first U.S. approved treatment for so-called face-wasting disease in HIV patients, it said the Food and Drug Administration should take steps to limit the product's use. The agency usually follows the advice of its expert panels. Dermik Laboratories, an Aventis subsidiary, is seeking limited approval for Sculptra, but some experts say the synthetic polymer could become a popular wrinkle aid. Once a drug is approved, doctors are free to prescribe it for other "off-label" uses. "Twenty-four hours after this is available, it's going to be used off-label," said panelist Dr. Neal Penneys. Antiretroviral drugs that are used to treat the virus causing AIDS can also lead to fat loss in the face, causing deep wrinkles and sunken cheeks. At the panel, HIV patients who tried Sculptra pleaded with FDA to quickly approve it, saying it had restored their dignity and saved them from suicide. Some testified anonymously, adding that a healthy-looking face was key to concealing their disease. "This is my face. This is my calling card and it is who I am," one woman diagnosed with HIV in 1996 said through tears. Bradley Land, who contracted HIV in the early 1980s, said even though he could cope with the infection, "By 1998, I looked as if I was on my deathbed." Sculptra is already marketed in Europe as a wrinkle-filler under the name New-Fill and is used in more than 30 countries. But panel members said U.S. doctors who might use it on anyone other than HIV patients should think twice, calling for strong label warnings and other conditions. They also called for further trials including minorities and women. Most trial patients studied were white men in their early forties who had HIV for more than 10 years. The company said it plans to start cosmetic trials this year and will eventually seek U.S. approval for Sculptra as a wrinkle treatment. Aventis has said Sculptra could be a blockbuster drug in the United States with more than $1 billion in potential annual sales. Shares of Aventis closed down 83 cents, or 1.1 percent, to $74.53 on the New York Stock Exchange.  |
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