| <DIV align=left><FONT size=4> （翻译稿，翻译的不好，请参考原文）</FONT></DIV>
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<DIV align=left><FONT size=4> 2009年五月20号----美国FDA已经批准了治疗克罗恩病的药物Cimzia，该药用于治疗成年人常规治疗无效的中度至重度类风湿关节炎。</FONT></DIV>
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<DIV align=left><FONT size=4> 这一消息来自UCB，Cimzia的制造公司 。</FONT></DIV>
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<DIV align=left><FONT size=4> Cimzia的靶位是称为TNF-α的炎症复合物 。该药每隔两周或四周注射一次，可以单独或与甲氨蝶呤一起使用。</FONT></DIV>
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<DIV align=left><FONT size=4> FDA首次批准是在2008年4月，用于成年人其他治疗无效的克罗恩病。</FONT></DIV>
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<DIV align=left><FONT size=4> 在新闻发布会上，UCB公司指出，FDA是在临床试验的基础上批准Cimzia用于治疗类风湿关节炎，试验中超过2300类风湿关节炎患者使用了Cimzia和甲氨蝶呤，与单独使用甲氨蝶呤组相比较，治疗24周后在类风湿性关节炎症状和体征上有较大的减轻，有些患者在使用一到两个星期后就表现出临床疗效。</FONT></DIV>
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<DIV align=left><FONT size=4> 该公司还指出与单独使用甲氨喋呤相比，联用Cimzia和甲氨蝶呤也能延缓关节损伤进展。</FONT></DIV>
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<DIV align=left><FONT size=4> Cimzia临床试验中偶见的不良反应包括感染，如结核病，和恶性肿瘤，如淋巴瘤。这两个风险都在Cimzia的说明书上已经注明。</FONT></DIV>
<P><FONT size=4> 最常见的不良反应则是上呼吸道感染，皮疹，及尿路感染。</FONT></P>
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<P>原文</P>
<DIV>May 20, 2009 — The FDA has approved the Crohn’s disease drug Cimzia to treat moderate to severe rheumatoid arthritis in adults who have had an inadequate response to conventional therapy.</DIV>
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<DIV>That news comes from UCB, the drug company that makes Cimzia.</DIV>
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<DIV>Cimzia targets an inflammatory compound called TNF-alpha. It’s given by injection at intervals of every two weeks or every four weeks, alone or with another drug called methotrexate.</DIV>
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<DIV>The FDA first approved it in April 2008 to treat Crohn’s disease in adults who haven’t responded to other treatments.</DIV>
<DIV> </DIV>
<DIV>In a news release, UCB states that the FDA approved Cimzia to treat rheumatoid arthritis based on clinical trials in which more than 2,300 rheumatoid arthritis patients taking Cimzia with another drug, methotrexate, had a greater reduction in signs and symptoms of RA after 24 weeks of treatment, compared to patients only taking methotrexate. Some patients showed clinical responses to Cimzia plus methotrexate within one to two weeks.</DIV>
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<DIV>Patients taking Cimzia and methotrexate also had a slower progression of joint damage during the trial than patients only taking methotrexate, according to UCB.</DIV>
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<DIV>Adverse events seen in Cimzia’s clinical trials included infections such as tuberculosis and malignancies such as lymphoma. Both of those risks are noted on Cimzia’s label.</DIV>
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<DIV>The most commonly reported adverse events in Cimzia’s clinical trials were upper respiratory tract infections, rash, and urinary tract infections.</DIV> |
