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【drug-news】FDA极可能批准HIV治疗新药
April 25, 2007 7:34 a.m. EST
Nidhi Sharma - AHN Staff Writer
Washington D.C. (AHN) - The U.S. Food and Drug Administration is likely to approve maraviroc, a novel drug that targets the cells of HIV-infected patients and not the virus itself.
Manufactured by Pfizer, the drug received a unanimous vote from 12 health advisers to sell under the brand name Celsentri. It would represent the first so-called CCR5 receptor antagonist to be sold.
If approved, maraviroc would be the first member of a new class of oral HIV medicines in more than a decade that block a secondary but crucial doorway typically used by the human immunodeficiency virus to enter white blood cells, which are important in the immune system.
Additional studies are underway to determine maraviroc's effectiveness in treatment-naive patients and also its interaction with other drugs and its effects on women and minorities.
According to earlier studies, adding Celsentri to a traditional HIV treatment regimen was more effective in dropping the virus below detectable levels. HIV is the virus that causes AIDS.
However, the federal authorities are worried over possibility of greater risk of infection, lymphoma or liver damage in HIV patients. The drugs also have been linked to heart rhythm changes in laboratory animals.
Though no increase in lymphomas or infections was detected among patients given Celsentri, but there was a modest increase in liver problems. Also, the drug has no significant impact on the heart, and no increased incidence of liver problems, cancer or infection compared with treatment involving other HIV drugs.
http://www.allheadlinenews.com/articles/7007149726 本人认领此文。如在48小时内未能提交译文，其他战友可自由认领。 FDA极可能批准HIV治疗新药
FDA Likely To Approve New Drug For HIV Treatment
April 25, 2007 7:34 a.m. EST
Nidhi Sharma - AHN Staff Writer
Washington D.C. (AHN) - The U.S. Food and Drug Administration is likely to approve maraviroc, a novel drug that targets the cells of HIV-infected patients and not the virus itself.
美国食品与药品管理局（FDA）可能批准一种作用于HIV感染的病人的细胞而不是病毒本身的新药maraviroc。
Manufactured by Pfizer, the drug received a unanimous vote from 12 health advisers to sell under the brand name Celsentri. It would represent the first so-called CCR5 receptor antagonist to be sold.
辉瑞药厂生产的药物在12个健康顾问一致同意的情况下，以Celsentri作为商品名进行销售。它将是销售的第一代的CCR5受体拮抗。
If approved, maraviroc would be the first member of a new class of oral HIV medicines in more than a decade that block a secondary but crucial doorway typically used by the human immunodeficiency virus to enter white blood cells, which are important in the immune system.
如果能够得到批准，maraviroc将是在十年中HIV口服药物中可以封锁人类免疫缺陷病毒进入白细胞的通道的新的种类的第一个成员。
Additional studies are underway to determine maraviroc's effectiveness in treatment-naive patients and also its interaction with other drugs and its effects on women and minorities.
另外还有研究用于测试maraviroc在首次用于治疗的病人和在妇女儿童身上的效应和与其他药物之间的相互作用。
According to earlier studies, adding Celsentri to a traditional HIV treatment regimen was more effective in dropping the virus below detectable levels. HIV is the virus that causes AIDS.
根据先前的研究，在传统的HIV治疗基础上加用Celsentri将更有效的将病毒减少致检测水平以下。HIV是AIDS的致病病毒。
However, the federal authorities are worried over possibility of greater risk of infection, lymphoma or liver damage in HIV patients. The drugs also have been linked to heart rhythm changes in laboratory animals.
然而，联邦当局担心可能造成HIV病人的更高的感染率、淋巴瘤或肝细胞损伤。这个药物在实验动物身上引起心脏节律的改变。
Though no increase in lymphomas or infections was detected among patients given Celsentri, but there was a modest increase in liver problems. Also, the drug has no significant impact on the heart, and no increased incidence of liver problems, cancer or infection compared with treatment involving other HIV drugs.
虽然在病人身上应用Celsentri并增加没有淋巴瘤或感染的发生，但是增加了肝脏问题的发生。并且，这个药物与其他的HIV药物合用，对心脏没有明显的影响，也不会增加肝脏、癌症或感染。
http://www.allheadlinenews.com/articles/7007149726
编译：FDA极可能批准HIV治疗新药
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作者:admin@医学,生命科学 2011-06-27 05:17
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