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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
" Z2 f! n7 I7 C( o r9 u# qDiabetes Mellitus — Evaluating Cardiovascular Risk in New % O! {1 Y. C8 T! w2 C0 M" G
Antidiabetic Therapies to
' V; C7 T( w9 oTreat Type 2 Diabetes3 `" w/ P- r' [' @; o" B, _& T
6 m& R* w8 j# @8 {8 v% j- F
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：
4 d5 o/ O9 b: G6 x
) u! Q1 P" D& t' FI. INTRODUCTION
9 g" w. y5 I1 Z, b" x/ d4 A# bThis guidance provides recommendations for the development of drugs and therapeutic biologics
6 j5 ?0 r0 m7 q& A+ B& f; S) oregulated within the Center for Drug Evaluation and Research at the Food and Drug : _* h: a0 w W4 X9 ?* m
Administration (FDA) for the treatment of diabetes mellitus.2
' S+ }4 I6 B% J( ]) x/ {$ v Specifically, this guidance makes 4 O( h. Z- x7 T& j7 W/ @2 a
recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2 ! |6 u& W8 ?, ~
diabetes is not associated with an unacceptable increase in cardiovascular risk. \8 K+ E7 D: c) W5 j: {
7 Q+ g$ E5 i( z
I 介绍
2 u( H3 Z, `, ^% t" `+ w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。0 Q# E; i" u; u% \$ d
& D, h8 O7 {% Q1 KII. BACKGROUND 0 P6 Q8 s) g3 \, N1 V* ~; L
Diabetes mellitus has reached epidemic proportions in the United States and more recently ]# T' T' G9 q' W) R
worldwide. The morbidity and mortality associated with diabetes is anticipated to account for a : q$ P: Z, ~ {' G
substantial proportion of health care expenditures. Although several drug treatments currently 1 n5 b1 l! u$ E. j
are available, we recognize the need for new agents for the prevention and treatment of diabetes
5 c( `1 G9 Q* I7 M4 a! S0 ^, v- U(e.g., development of drugs and therapeutic biologics).
5 w6 H+ Z: M5 S* J( K) q# g! r W: T7 I$ k3 f. [
II 背景/ S0 x% Q+ K8 G3 j: n* z% D
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）。& ]" j: E0 g, W% ?/ r
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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
