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【drug-news】FDA批准增加适用范围用于重度阿尔茨
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P06-168
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FDA Approves Expanded Use of Treatment for Patients
With Severe Alzheimer's Disease
FDA批准了扩大适应症的申请以用于治疗重度阿尔茨海默病患者
The Food and Drug Administration (FDA) today approved Aricept (donepezil hydrochloride) for the treatment of severe dementia in patients with Alzheimer's Disease.
今天美国食物和药品管理( FDA )批准了Aricept (盐酸多奈哌齐)可适用于治疗重度痴呆的阿尔茨海默病患者。
Aricept was previously approved for the treatment of mild to moderate dementia of the Alzheimer's type. It now becomes the first product approved for the treatment of all degrees of severity of the disease.
"Alzheimer's Disease is a devastating, age-associated brain disorder that affects an estimated 4.5 million Americans -- and, as our population grows older, this number is expected to multiply," said Dr. Steven Galson, director of the Center for Drug Evaluation and Research. "Today's approva Aricept l makes available another treatment for those with severe dementia."
Aricept早先批准用于治疗轻度和中度的痴呆阿尔茨海默病患者类型,.现在它批准成为治疗阿尔茨海默所有程度包括严重痴呆的一线产品.
“阿尔茨海默病是一种致命的，与年龄相关的脑功能紊乱疾病,估计它影响了大约450万个美国人--；同时随着老年人口的数量增加,这个数值估计是成倍增加的，”美国药物评价和研究中心Galson Steven博士说。 “今天的批准是为了那些严重的痴呆患者可获得不同的治疗”。
approved Aricept to treat patients with mild to moderate Alzheimer's Disease ten years ago after two clinical trials demonstrated that patients receiving the drug performed better than patients who received placebo. Today's approval is based on two additional randomized, placebo-controlled, 24-week clinical studies conducted in Sweden and Japan in more than 500 patients with severe Alzheimer's Disease.
在10年前,经过两个结果显示为药物组疗效优于安慰剂组的临床实验,FDA批准Aricept治疗轻度和中度痴呆阿尔茨海默病,,现在的批准是基于另外的两个随机安慰-对照组实验,此实验对瑞典和日本超过500个重度阿尔茨海默病人进行了24周临床研究.
In these studies, the effectiveness of treatment with Aricept was determined by evaluating the patients' cognitive functions such as memory, language, orientation and attention, as well as their overall functioning. The results showed that patients on Aricept performed better on both measures compared to placebo.
在这些研究中，接受Aricept治疗的有效性是通过病人的诸如记忆，语言,方向和注意力等的认知功能来评价,认知的全部机能来用来综合评价。 结果显示那些用Aricept治疗的病人,在两种评价方法下,效果均比安慰剂组强.
Aricept is manufactured by Eisai Inc., Teaneck, N.J.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01491.html 个人觉得有些地方不太妥当，供参考讨论。
FDA Approves Expanded Use of Treatment for Patients With Severe Alzheimer's Disease
FDA批准扩大Aricept 适应症范围，用于治疗重度阿尔茨海默病患者
Aricept was previously approved for the treatment of mild to moderate dementia of the Alzheimer's type. It now becomes the first product approved for the treatment of all degrees of severity of the disease.
.......现在它批准成为治疗阿尔茨海默所有程度包括严重痴呆的一线产品.
此处的first ，我觉得从句子的结构上看，不是指第一线，而是说 Aricept成为第一个被批准可以用来治疗所有程度阿尔茨海默病的药。
"Alzheimer's Disease is a devastating, age-associated brain disorder that affects an estimated 4.5 million Americans -- and, as our population grows older, this number is expected to multiply," said Dr. Steven Galson, director of the Center for Drug Evaluation and Research. "Today's approval makes available another treatment for those with severe dementia."
美国药物评价和研究中心Galson Steven博士说：“阿尔茨海默病是一种致命的与年龄相关的脑功能紊乱，它影响了大约450万美国人。随着人口老龄化，这个数值可能成倍增加。现在Aricept被批准（应用于所有阿尔茨海默病），使那些严重的痴呆患者可获得另一种治疗”。
approved Aricept to treat patients with mild to moderate Alzheimer's Disease ten years ago after two clinical trials demonstrated that patients receiving the drug performed better than patients who received placebo. Today's approval is based on two additional randomized, placebo-controlled, 24-week clinical studies conducted in Sweden and Japan in more than 500 patients with severe Alzheimer's Disease.
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作者:admin@医学,生命科学 2010-12-19 17:11
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