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A Food and Drug Administration( FDA) advisory committee has concluded that a novel new treatment can greatly help rheumatoid art
A Food and Drug Administration( FDA) advisory committee has concluded that a novel new treatment can greatly help rheumatoid art
admin
2022-05-19
39
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.
Which of the following might be an appropriate title for the text?
选项
A、TNF and Immune System
B、Enbrel versus Methotrexate
C、Arthritis Drug on Path to Approval
D、Study on Rheumatoid Arthritis
答案
C
解析
全篇文章介绍一种治疗风湿性关节炎的新药恩利的药理作用以及可能造成的风险,并说明由于新药的风险。食品药品管理局对于审批十分谨慎,敦促进行长期的安全性研究。C项“关节炎药物的审批之路”涵盖了文章的主要内容,为正确选项。
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