海淘家园 - 海淘GNC/高血压/糖尿病/减肥等保健品

标题: 美国FDA：糖尿病-在新的降糖疗法治疗2型糖尿病评估心血管疾病风险 [打印本页]

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作者: michaelr    时间: 2013-11-22 11:25
标题: 美国FDA：糖尿病-在新的降糖疗法治疗2型糖尿病评估心血管疾病风险
糖尿病-在新的降糖疗法治疗2型糖尿病评估心血管疾病风险2008年10月
Diabetes Mellitus — Evaluating Cardiovascular Risk in New
& }- k7 j5 a/ Q) L0 [6 AAntidiabetic Therapies to
* ~' M1 G, i+ n/ q9 B9 ^Treat Type 2 Diabetes
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这个文件比较大，先翻译一段，有兴趣的TX可以下载自己去看看：
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9 F1 _6 x& O1 ~! c* O1 t' z3 G5 H  KI. INTRODUCTION
This guidance provides recommendations for the development of drugs and therapeutic biologics
. H8 n+ f$ i( ~3 C3 oregulated within the Center for Drug Evaluation and Research at the Food and Drug
: X- t$ ?* [# f6 |& V& a& t2 Y3 V5 ~. ?Administration (FDA) for the treatment of diabetes mellitus.2
" z8 @  C6 \( C/ u9 j Specifically, this guidance makes
8 g/ F2 F! y, I; krecommendations about how to demonstrate that a new antidiabetic therapy to treat type 2
diabetes is not associated with an unacceptable increase in cardiovascular risk.

I 介绍
本指导提供了FDA关于治疗糖尿病，在药物和治疗性生物制品的开发方面的一些建议。尤其本指导会对II型糖尿病人介绍一种新型的降糖治疗，对心血管方面不会有无法接收的风险提高。
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$ O8 t) g% b8 x3 R. F) cII. BACKGROUND
Diabetes mellitus has reached epidemic proportions in the United States and more recently
! M6 _+ X8 s1 a$ |9 W& a/ cworldwide. The morbidity and mortality associated with diabetes is anticipated to account for a
substantial proportion of health care expenditures. Although several drug treatments currently
are available, we recognize the need for new agents for the prevention and treatment of diabetes
  T4 o+ b9 a$ ~1 s; u(e.g., development of drugs and therapeutic biologics).
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II 背景
在美国乃至全世界，糖尿病已经达到了流行病的程度。由糖尿病引发的发病率和死亡率，在医疗费用支出中已经占相当大的比例。虽然现在已经有很多的治疗药物，我们意识到需要新的药品来阻止和治疗糖尿病（如，药物和治疗性生物制品）。

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