|
|
|
只花1分钟注册，更多海淘保健品信息等着你
您需要 登录 才可以下载或查看，没有帐号？立即注册
x
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5 ` n$ R* b2 s
Diabetes Mellitus — Evaluating Cardiovascular Risk in New 5 i7 C/ ?+ {) ~- _" N/ C' ?% h9 {# R
Antidiabetic Therapies to / F3 A' X, V: S6 ^, o" U* H
Treat Type 2 Diabetes u% c% o X) J# j( i4 K
- _; O5 N2 L Z' d- l: k/ h
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：2 a0 Y% {' F* X+ k' ?1 F) A9 Y4 l
* _/ D* Y/ c7 h( X9 X
I. INTRODUCTION
( k# t( o E1 g) ^This guidance provides recommendations for the development of drugs and therapeutic biologics
- J. ?" _6 q3 E0 N$ r8 qregulated within the Center for Drug Evaluation and Research at the Food and Drug ! v# C# P, M; p
Administration (FDA) for the treatment of diabetes mellitus.24 w0 |* v Y7 G9 ?
Specifically, this guidance makes
9 I- _' V- @1 D4 H3 y# L1 D5 ]recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2 + z- C$ |8 H& X
diabetes is not associated with an unacceptable increase in cardiovascular risk.
- z4 }. | g8 l7 I7 P) {; k; x8 d; c' Z$ {4 u! t: Y3 P
I 介绍
: P) F! q7 H. v9 Y5 b5 {- l0 q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。
; \ Y0 ]0 L" Y# M- z) p: j& E+ O3 z, w5 d+ o$ W: h8 R
II. BACKGROUND 9 q$ ~- Z4 x ]2 A9 z
Diabetes mellitus has reached epidemic proportions in the United States and more recently
1 o6 M! M5 }0 uworldwide. The morbidity and mortality associated with diabetes is anticipated to account for a
3 m0 A0 K. I: Ksubstantial proportion of health care expenditures. Although several drug treatments currently
, S5 ~* y# Z. Aare available, we recognize the need for new agents for the prevention and treatment of diabetes
" d3 Z7 i+ ~$ j. G w% v- [3 d(e.g., development of drugs and therapeutic biologics).
9 w2 F. V4 M2 T; Y4 S w$ i5 w2 `9 s1 y' {* r7 T: `8 O
II 背景
0 W" }7 U7 X$ M! U/ 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）。% [# |+ H7 G; B$ w# p/ W7 O
|
|
发表于 2013-11-22 11:25:59
收藏
分享
微信分享
发表于 2013-12-6 22:56:05
楼主
