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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
1 W1 ?: G& _* R8 wDiabetes Mellitus — Evaluating Cardiovascular Risk in New & j% s, O+ S: h" \. D7 P( X
Antidiabetic Therapies to * O3 M8 I8 a$ @1 p0 G% F6 O; g
Treat Type 2 Diabetes* K! F; j( Y& m( p
! o9 w U) r" k7 q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：; O0 s4 D z/ ?4 Z* I
6 o7 u* u% C' o8 O: L, DI. INTRODUCTION - p+ f E; \9 g, v) I( S* v5 v
This guidance provides recommendations for the development of drugs and therapeutic biologics & t% u4 |% \! f9 Z
regulated within the Center for Drug Evaluation and Research at the Food and Drug
% l' f5 ?; V) w) a* o! D4 Q% @6 t* nAdministration (FDA) for the treatment of diabetes mellitus.2
; Q+ A" J2 A6 k$ @ Specifically, this guidance makes
: _9 m* M! z, C+ K5 M6 I) Mrecommendations about how to demonstrate that a new antidiabetic therapy to treat type 2
N) ?( S0 l( g9 y5 Xdiabetes is not associated with an unacceptable increase in cardiovascular risk. ! u0 y Y3 a: g4 f5 D' j, R
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I 介绍
; V2 Y2 p E2 Z2 f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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' l) R; _+ r+ W( w% O5 ^II. BACKGROUND , V/ |4 J1 [1 s1 h" S
Diabetes mellitus has reached epidemic proportions in the United States and more recently
9 i% j; g. \3 L Aworldwide. The morbidity and mortality associated with diabetes is anticipated to account for a * k* _. i/ y3 h" o- o4 e* d
substantial proportion of health care expenditures. Although several drug treatments currently ! ?4 s1 _1 d5 r. P, V3 {/ L$ W
are available, we recognize the need for new agents for the prevention and treatment of diabetes u; U K I- ~; P$ G
(e.g., development of drugs and therapeutic biologics). ( j. G) n0 k0 a+ t) [ Y
" K8 D# l L9 MII 背景
% O& _% ~; Z7 U2 H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
