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  3. A Food and Drug Administration (FDA)advisory committee has concluded that a novel new treatment can greatly help rheumatoid arth

A Food and Drug Administration (FDA)advisory committee has concluded that a novel new treatment can greatly help rheumatoid arth

admin2019-04-08  66
问题     A Food and Drug Administration (FDA)advisory committee has concluded that a novel new treatment can greatly help rheumatoid arthritis patients.
    The panel recommended approving Enbrel for use alone in patients who haven’ t responded to other drugs or in combination with methotrexate, a cancer drug that has been the main treatment for rheumatoid arthritis.
    The FDA must make a final decision by early November, and the drug’ s maker says it could be on the market by year’ s end.
    In rheumatoid arthritis, which affects 2.1 million Americans, the immune system attacks healthy joints. A major wrongdoer in this process is a protein called "tumor killing factor" , or TNF, which interacts with a special molecule, or TNF receptor, on cells’ surfaces.
    To keep inflammation in check, cells normally release some receptors to mop up excess TNF, rendering it inactive. Apparently, rheumatoid arthritis patients don’t have enough free-floating TNF receptors.
    Enbrel consists of genetically engineered TNF receptors. In a six-month study, 234 patients with advanced rheumatoid arthritis received one of two doses of Enbrel or a placebo (harmless substance given as if it were medicine)in twice-a-week injections. They took injections for six months. By the end, 40% of patients on the larger Enbrel dose saw symptoms, such as swelling and joint pain, cut in half. Only 5% on the placebo did that well. The main side effect was minor irritation at the injection site.
    Because some TNF is needed for a normal immune response, there is at least a theoretical risk of infections or even cancer in patients who take Enbrel, so the FDA panel urged long-term safety studies.
    Last week, the FDA approved Arava, an oral treatment for rheumatoid arthritis that is similar to methotrexate. While calling both Enbrel and Arava "potentially very important" , Brian Butcher, vice president for research at the Arthritis Foundation, notes they have been tested in relatively few patients.
    Butcher says their safety should be closely monitored once they’ re widely available.
The wide use of the new drug Enbrel relies much on
选项 A、justification of the new treatment.
B、a new monitoring system.
C、mass production of the drug.
D、long-term safety studies.
答案D
解析 该题为推理题。由第七段“Because some TNF…so the FDA panel urged long-term safety studies．”可知，因为一些肿瘤坏死因子对正常的免疫反应是必需的，使用恩利的患者至少在理论上会遭受感染或者甚至癌症的风险，因此，食品药品管理局专门小组敦促进行长期的安全性研究。由最后一段“Butcher says their safety should be closely monitored once they’re widely available”可知，一旦它们被广泛使用，它们的安全性应得到严密监测。由此可推断，恩利的广泛应用取决于长期的安全性研究，故选D。
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