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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
) r" L7 }$ k5 s% y5 f! aDiabetes Mellitus — Evaluating Cardiovascular Risk in New 4 k9 e4 s; G% X! p# \; R
Antidiabetic Therapies to
( n8 X+ ^$ ^$ n/ b: BTreat 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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6 r/ n; o: M# r6 u1 G+ w9 nI. INTRODUCTION
! o; }1 W D- y, Z# F1 Z2 ^1 Y2 EThis guidance provides recommendations for the development of drugs and therapeutic biologics
- h$ v8 B* P( u* o. Z, Z2 Pregulated within the Center for Drug Evaluation and Research at the Food and Drug
! S8 Y( W1 E0 u; \" fAdministration (FDA) for the treatment of diabetes mellitus.2
9 B Z5 @- }/ C! S. s1 v+ t. L Specifically, this guidance makes 2 U" c5 f ]4 ^0 W$ U% u
recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2 7 B3 d: B) A* L% X* o) ?4 Z5 R2 N
diabetes is not associated with an unacceptable increase in cardiovascular risk.
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I 介绍5 S) m# ]% N0 i, V a
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。! C! g d3 f) Z2 X5 G
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II. BACKGROUND . R2 d- Z t: P3 @. Q
Diabetes mellitus has reached epidemic proportions in the United States and more recently ' Z" {$ ^5 X: M0 U; f' l
worldwide. The morbidity and mortality associated with diabetes is anticipated to account for a 1 _) @1 i" }7 _0 }
substantial proportion of health care expenditures. Although several drug treatments currently 3 J7 Z( d3 \3 l& P4 P
are available, we recognize the need for new agents for the prevention and treatment of diabetes
1 b6 q, H6 E+ l& O% Q(e.g., development of drugs and therapeutic biologics). ! V2 _/ }1 _# O
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II 背景
5 p9 h' @# j" \2 t# P$ A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）。8 B2 i: b5 {* z$ w" n
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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
