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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
0 S6 ^4 y# q: l2 H1 H- r& SDiabetes Mellitus — Evaluating Cardiovascular Risk in New + f( E C4 i6 v: T! q
Antidiabetic Therapies to g6 B1 D& ~% z4 R9 ? t8 _
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：7 W% b# Z/ f: S6 k. a/ B0 l
( S! m; E8 m0 \$ I3 ?7 {& TI. INTRODUCTION
. P; T! z" Z; m9 X' X$ XThis guidance provides recommendations for the development of drugs and therapeutic biologics
$ G8 v5 o6 r: ?& l6 |7 Yregulated within the Center for Drug Evaluation and Research at the Food and Drug 3 ]6 [1 G' ?/ I u {8 e
Administration (FDA) for the treatment of diabetes mellitus.2
9 K# n5 [. }! \3 x- q U: y Specifically, this guidance makes ; i, o1 o3 _& M# s7 l
recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2
7 i* x7 g+ N" ?3 K8 |( v3 |diabetes is not associated with an unacceptable increase in cardiovascular risk.
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3 U/ _+ R) _* }( {9 VI 介绍0 `. ?, N1 h/ K1 T
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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II. BACKGROUND $ G+ m R% A/ \( {5 P
Diabetes mellitus has reached epidemic proportions in the United States and more recently
$ e; [7 S& d2 o8 z# Qworldwide. The morbidity and mortality associated with diabetes is anticipated to account for a ) x( B5 r6 E$ T. t& z
substantial proportion of health care expenditures. Although several drug treatments currently 6 U' V3 o8 ^9 T9 D
are available, we recognize the need for new agents for the prevention and treatment of diabetes
) t; X/ B. F: @/ x" G4 R8 `(e.g., development of drugs and therapeutic biologics).
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II 背景% e- j- K, |0 Q1 k
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）。( H: v8 p- s }" X7 V$ @8 j
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发表于 2013-11-22 11:25:59
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发表于 2013-11-22 23:06:17
