THURSDAY, Dec. 20, 2012 (HealthDay News) —A U.S. Food and Drug Administration advisory committee will meet Thursday to consider approval of the first drug to treatchronic fatigue syndrome。
专家们将讨论与静脉内药物rintatolimod（拟议的品牌Sampigen）相关的风险和益处。这drug'smaker, Hemispherx Biopharma of Philadelphia, failed to win the FDA's OK in 2009 because of concerns about study methodology.
Experts said they would welcome a treatment for chronic fatigue, a disabling condition that affects as many as 4 million Americans, mostly women. There is no cure, but the drug appears to reduce symptoms for some patients.
"It does seem to help at least a subset of patients significantly. For others, there isn't a significant response," said K. Kimberly McCleary, president of the Chronic Fatigue and Immune Dysfunction Syndrome Association of America.
"This drug has been studied in chronic fatigue syndrome since the late 1980s, so it's been around for a while," McCleary added.
Dr. Nancy Klimas, professor of medicine at Nova Southeastern University College of Osteopathic Medicine in Fort Lauderdale, Fla., who is part of an ongoing trial of the drug, said some of her patients have benefitted from the drug. Now there needs to be a way to identify which patients will do well on the drug, she added.
Klimas说，慢性疲劳综合征很少明朗地理解，并且Ampligen的批准将使患者与保险公司有些人说。
“即使是单一批准的治疗，即使是我选择不使用的批准治疗，当我与保险公司争论合法化条件时，也会非常有帮助，并且它足够严重需要进行干预，”Klimas说。
According to the drug company, Ampligen is a new type of drug called a nucleic acid compound, which uses specially made RNA to target a variety of diseases. Hemispherx believes the drug has the potential to fight艾滋病病毒, kidney cancer and黑色瘤除了慢性疲劳综合征。
通过调节患病细胞的免疫和抗病毒功能来调节该药物。
One drawback of the treatment is that it needs to be infused twice a week, Klimas said. It also is very expensive, she said.
这maker of the drug couldn't estimate the retail cost but said the manufacturing cost is about $1,000 a month per patient.
这FDA denied approval for Ampligen in November 2009 because of concerns about the way two studies were conducted -- too few patients, a protocol change and an early end to one study. This time around, the FDA will review a new analysis of one trial result submitted in 2009, but not a new study.
缺乏支持数据可能再次抵押批准。“试验的多项行为问题表明，结果应谨慎解释，”该机构在委员会的一封信中表示。“确认试验未能复制”第一次试验的结果。
9月，FDA进行了一个电话会议慢性疲劳综合征的人谁用过药物。这些轶事报告主要是积极的。如果有的话，这些患者经历将对药物的批准有何重视。
一些专家认为慢性疲劳综合征是病毒;其他人认为它是一种细菌。麦克喀蒂说，患者从中患者患者患病并不完全恢复的疾病，或者症状可能会出现症状。
通常包括流感样症状的弱点。一个common thread is the inability to do almost anything without becoming totally exhausted, McCleary said. Even simple tasks like reading a magazine can set off a cascade of symptoms that last for days or weeks, she said.
“这是一个骨髓疲惫，”麦克蒂说。“肌肉和关节有疼痛，可以从一个身体部位移动到另一个身体，sore throat，头痛就像偏头痛，麻烦睡着或睡着了。“
麦克湿指出，有精神症状，包括难以处理信息和“大问题”，麦克蒂。
FDA的决定预计明年初。原子能机构不得遵循其咨询面板的建议，但通常会这样做。
