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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- v$ r! B" |$ E
Diabetes Mellitus — Evaluating Cardiovascular Risk in New 8 I: h/ R" ?4 ?7 g, Q
Antidiabetic Therapies to
* @, s: i3 A/ o% c7 d# KTreat 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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I. INTRODUCTION
; P; [) _) z. TThis guidance provides recommendations for the development of drugs and therapeutic biologics
; S7 t" L) M8 pregulated within the Center for Drug Evaluation and Research at the Food and Drug 3 L, a; a4 w0 O1 e( S
Administration (FDA) for the treatment of diabetes mellitus.2
" H' p+ m& R4 }8 a- i Specifically, this guidance makes
+ ]3 B0 u# |3 w6 Jrecommendations about how to demonstrate that a new antidiabetic therapy to treat type 2
$ g0 p/ B" F1 Tdiabetes is not associated with an unacceptable increase in cardiovascular risk. ; _ k; D% N( ^# [6 e L$ I& N1 a$ K4 F
: s, V; r3 W9 x$ F; z8 Y& VI 介绍" R% Y8 M; b7 z. K9 T1 W1 ^& G
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。$ x# _% K. T0 B- ]5 W
r( i* l' g+ {5 YII. BACKGROUND
1 R$ M5 x. b ] m" T9 d' o4 h- iDiabetes mellitus has reached epidemic proportions in the United States and more recently
5 {! K/ S! W- n4 M3 s; L: Q2 ^. zworldwide. The morbidity and mortality associated with diabetes is anticipated to account for a
- k9 f; r6 Z, x& e2 i; Rsubstantial proportion of health care expenditures. Although several drug treatments currently . P# N! _3 [. _! b/ z: ]2 P
are available, we recognize the need for new agents for the prevention and treatment of diabetes
% t* l& n: w4 H6 d(e.g., development of drugs and therapeutic biologics). 5 S. B0 R4 j# T* ]' v
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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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发表于 2013-11-22 11:25:59
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发表于 2013-11-22 23:06:17
