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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( ]& ?0 i, R, ]0 Q0 s) i/ h
Diabetes Mellitus — Evaluating Cardiovascular Risk in New $ X/ K6 j0 F, u
Antidiabetic Therapies to 2 _. \$ t, r n, T
Treat Type 2 Diabetes
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; i7 i( b, e8 w( a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：- V4 c7 a6 f1 M" T K7 j$ v# j2 P, ?
5 f) g* Y" ~/ q1 g) b6 i3 vI. INTRODUCTION & A2 L* l" k4 ?; [6 M
This guidance provides recommendations for the development of drugs and therapeutic biologics ) r9 P* y5 m+ ^- N% s5 }
regulated within the Center for Drug Evaluation and Research at the Food and Drug & }9 o4 n V' X. i5 J
Administration (FDA) for the treatment of diabetes mellitus.2
* z7 u) w- q% L `3 s Specifically, this guidance makes 8 \9 j8 r) _% R" i
recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2
; e4 A* r3 q, j8 D1 B. g, s3 wdiabetes is not associated with an unacceptable increase in cardiovascular risk.
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I 介绍
3 V, U( z% c: 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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0 q$ m$ O7 e6 T S0 hII. BACKGROUND
2 p6 ]2 c0 a1 F9 TDiabetes mellitus has reached epidemic proportions in the United States and more recently % W7 Z% Q% {% E& ~' I
worldwide. The morbidity and mortality associated with diabetes is anticipated to account for a 7 w0 M% ^, [8 c L
substantial proportion of health care expenditures. Although several drug treatments currently
7 K8 L$ j& t4 F) ]/ M- @) oare available, we recognize the need for new agents for the prevention and treatment of diabetes ) H. v& V" N5 P* O, Z
(e.g., development of drugs and therapeutic biologics). $ t+ o3 W q0 |6 c
7 G$ A5 n' N* b: R0 `II 背景
& z8 b' T9 i3 \( ]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
