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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
& O* g/ P+ u3 a* u! l1 ]Diabetes Mellitus — Evaluating Cardiovascular Risk in New 6 V8 H/ Q: L4 \9 Q# B% e" N5 ?: U
Antidiabetic Therapies to
9 ]+ r; L O) e! O6 k% cTreat 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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! d( F9 z: y. i* v4 y+ l1 D: K5 |I. INTRODUCTION ( f3 ~: q$ l7 Z, j
This guidance provides recommendations for the development of drugs and therapeutic biologics
% Q2 E# v T- m2 T0 S7 K0 yregulated within the Center for Drug Evaluation and Research at the Food and Drug - { W9 J6 g3 p# j
Administration (FDA) for the treatment of diabetes mellitus.2$ \ [8 v6 I9 M7 w& m* U; W
Specifically, this guidance makes 1 J R8 m! f' t5 A
recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2
! X! T9 q0 J! f9 z* X6 ?6 p- Qdiabetes is not associated with an unacceptable increase in cardiovascular risk. % [! f/ K% c: B
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I 介绍5 r$ C5 t& w/ y" }$ P: V" X
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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! Z: B. d, z+ Y: ^6 i& p5 `" VII. BACKGROUND
! I$ a! ?: j( A3 M8 @* C* c! vDiabetes mellitus has reached epidemic proportions in the United States and more recently
* [/ s9 W# k/ i! f& _* @, |" jworldwide. The morbidity and mortality associated with diabetes is anticipated to account for a
1 A+ V+ Q+ m7 M1 qsubstantial proportion of health care expenditures. Although several drug treatments currently 0 d1 x4 A4 U0 O, @! O
are available, we recognize the need for new agents for the prevention and treatment of diabetes
& ~9 a5 o. `' \$ v(e.g., development of drugs and therapeutic biologics).
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II 背景
$ C$ J4 t$ _ v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
