|
|
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
" ?, o! v( M% t) }* eDiabetes Mellitus — Evaluating Cardiovascular Risk in New
7 A2 b0 s7 q9 a9 p' t9 YAntidiabetic Therapies to
7 s4 u' F9 N C/ D+ oTreat Type 2 Diabetes1 @+ U& k) b* ?; R+ t' N& i+ Z
' k5 {6 x$ J0 u# b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：
' S/ N7 g- F1 j2 v6 P5 g
4 n) V4 ^% Q2 u/ KI. INTRODUCTION N7 q$ Z8 G9 @7 w- T D' N
This guidance provides recommendations for the development of drugs and therapeutic biologics
' }& d" N8 m( c7 o' V" L) s6 ^* eregulated within the Center for Drug Evaluation and Research at the Food and Drug * D( O: a9 |8 A; }
Administration (FDA) for the treatment of diabetes mellitus.20 \9 b0 N$ ^. u( w5 j2 G. D" v
Specifically, this guidance makes : ^# z0 {7 Y: h# x
recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2
4 z& H4 _; ?7 L0 `' d# B7 B. |diabetes is not associated with an unacceptable increase in cardiovascular risk. 1 B9 X$ C+ b5 o2 v( [
- Q# H7 ^4 `3 L8 ~. h
I 介绍
, J/ i' ?+ i! r- v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。
2 t6 M4 L, E! G2 u/ w3 n# V
% \6 f1 E3 p) { J" JII. BACKGROUND $ Q3 \, t: E. a, B9 K, `2 q
Diabetes mellitus has reached epidemic proportions in the United States and more recently
1 \. J4 ^3 w8 k! }worldwide. The morbidity and mortality associated with diabetes is anticipated to account for a ( P8 @- J. g) m" `
substantial proportion of health care expenditures. Although several drug treatments currently
1 B7 l/ s. T& A6 Q3 Fare available, we recognize the need for new agents for the prevention and treatment of diabetes ) L9 x" z2 E& {* _
(e.g., development of drugs and therapeutic biologics). " ^8 j$ p! s; ]' P4 \
0 g7 w; U- {3 ]; ?0 x, P, J. p2 O
II 背景
9 ^0 D- X/ p; |8 i: J$ Z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）。
2 a) p* F' `: U5 p
|
|
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
