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ƿ ...賭 񸸾 丮
Ȱ 2020-02-20 06:20:52
ƿ ...賭 񸸾 丮
Ȱ 2020-02-20 06:20:52
[DP] 񸸾 úƮ 䵿

10⸸ 1õ ... Ǵٽ ٶ



[ϸ=Ȱ ] 10Ⱓ ġ Ҵ. 1 'ƿ' 2010 ۿ Ǹ鼭 ڸ ä 鰣 Ż ġߴ. ' ġ ü߰ ȿ پ ϴ' ǰ ϰ, 索 ġ 뷮 ٲ '輾' ġ ó Ȱ⸦ ã ̴.

׷ '' Ϲߺ ö 鼭 . Ѷ ָ ǰ ޾ ߸ 鼭 ü 𸥴ٴ 尨 . ݻ ǰ ɵ .

ߺ񸸽 10⸸ Ըȸ...''

20 Ǿǰ ťƿ 3б ġ Ը 354 ⵿ 45.4% þ. 2017 4б ¼ ϸ鼭 2 70% ̻ Ȯƴ. 3б Ը 1009̴. 2009 10⸸ ó 1000 Ѿ.

ϵ '' ̾ ƿƼ 'Ʈ'(и ǿ/Ʈ) ߸ϴ ۷ι 簡 񸸽ž ϰ, ģ ̾ GLP-1 索 ġ 뷮 ٲ '輾' ϸ鼭 ⼼ ȸߴٴ м̴.

  2010-2019 ġ б⺰ (: , ڷ: ť)

׷ ó Ȱ⸦ ã ġ 忡 ٽñ ο ׸ڰ 帮. Ѷ ġ 1 ö ''(и ī) 鼭.

̱ǰǾǰ(FDA) 13(ð) ߻ ̿ '' ö ûߴ. ȯ 12000 CAMELLIA-TIMI 61 ӻ󿡼 ߺ Ұ ƴٴ .

CAMELLIA-TIMI 61 ȿ Ϸ ȹ ۷ι ӻ̴. 2014 1 2015 11 8 473 Ƿ 2 索 ڸ 12000 Ǵ ູ뱺 ο ɱٰ, ߰ ֿ(MACE) ߻ ߴ.

2 ȸ(ESC 2018) ø ص 뱺 MACE ߻ 6.1%, ౺(6.2%) 񿭵 ߴٴ ǥϸ鼭 ȭߴٴ 򰡸 ޾Ҵ.

  2018 ױ۷ο޵ſ ǥ CAMELLIA-TIMI 61 (ڷ: NEJM 2018;379:1107-1117)

FDA 2018 6 Ⱓ ø ֽ м 뱺 ߾ ߻(462, 7.7%) ౺(423, 7.1%) Ÿ. 뱺 , , Ϻ ߻ Ұ, ġⰣ Ҽ ౺ ߻ ̰ ϴ .

FDA Ƿ鿡 " ó ﰢ ߴؾ Ѵ. ȯڵ鿡 ӻ ߻ ˸, ߴϵ ġ϶" ǰߴ. ٸ Ѵٰ , ߴٴ ˻(screening) ʿ ٴ ̴.

FDA ̰ ġ 嵵 ߴ. '' ǸŸ ϴ ϵ ǰǾǰó Ǹų óߴܰ ϱ⿡ ռ XR 2 ǰ Ǹߴ ȴ.

ľó "ī Ǿǰ ؼ( ߻ ) ͼ(ü ) ȸϴ Ǵܵȴ" Ǹ Բ ȸ⸦ ߴ.

߽úƮ ȭ...

븦 Ҵ 񸸾 ó ƴϴ. ġ ָҴ Ŀ 'úƮ' Ǿǰ 2010 9 ġ .

úƮ 2010 1 Ǿǰû(EMA) ֺƮ 2003 9880 ӻ 'ƿ'(и úƮ) ȯ 11.4% ߴٴ Ǹߴ ϸ鼭 ˹ߵƴ.

ľó EMA ġ úƮ ó ϰ 忡 ܷ ߴµ, 10 ̱ FDA "úƮ ͼ ʰѴٰ Ǵܵ ʴ´" Ǹű ȴ.

  ( ð ) úƮ ƿ, , ũ, , Ŀ, ú彺 ǰ

'ƿ' ѹ̾ǰ '', 'Ŀ', ٴ 'ũ', '', Ѿ 'Ÿ' 39 60 ǰ ź Ծ.

ť б⺰ ġ Ը 2009 2б 282 úƮ Ǿǰ ް 2011 2б 139 丷. úƮ 鸸ŭ Ը ̴.

̹ úƮ 'Ÿ' , ġ óߴܵƴ. ͹ΰ ÷ Բ ϴ '-' Ǹ̻ ۿ FDAκ , Ǹű ó ޾Ҵ.

͹, Ʈ żǾǰ ȯ, ﰨ ۿ ߻ ̴.

ν ؾ 'Į(и øƮ)' Ѷ 츮 ̱ ̾ 2 ŭ α⸦ , ջ 뼺 Ÿ ؾ Ѵٴ 弼 .

Ϸ ´ 츮 忡 'ȿ ġ' Ű. FDA ġ 㰡ϴ 5% ̻ ü߰ ȿ ӻ ܿ ߰ ӻ ๰ ȿ ϵ 䱸ϸ鼭 㰡 ȭϱ⿡ ̸.
Ȱ (kjan@dailypharm.com) ٸ
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뺸 ϰ ̵ ̿ Ǵ ֽϴ.

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    Ư ̿ ο ν 弳

    Ư 븳 ϴ

    Ȯ ȵ ҹ Ű

    弳 , Ӿ

    Ź, ɿ ˵Ǵ ( û )

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    Ư ѼϿ ش ûϴ

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    Ÿ ID Ȥ г ϴ

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    ʴ

    翡 ߺ

    κ Ͽ ݺ ϴ 쵵

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    Խù б

  • û ִ

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    Ÿ ˵Ǵ 縦

    Ÿ  ڰ ʿϴٰ ǴܵǴ

  • Ȯ

    ۱ڷκ , , ϴ

    Ÿ ʻ ħϰų ϴ

    翡 ̿ (Ÿ ID, йȣ )

  • ̻ Ϻ ׿ ̿ 縦 , Ρ ó ֽϴ.

    õ ̴ ҹ Ǵܵǰų ϸ 񽺿 ٶ ʴٰ ǴܵǴ ġ ϰڽϴ.

    رŸ ϸ ڿ ֽʽÿ. ּҴ dailypharm@dailypharm.comԴϴ.

ֽż ݴ
  • 2020.02.20 10:47:19

    ְ ְ

    Һڵ 屸 ̿Ͽ ϰ ׵ ܹ Ծ

    0 0 0
ٺ Ϲݾ ǸŰ (2024 04)
౹ 31
ǰ ְ
ѽŻ÷(10) 3,500 2,500 1,000 3,009
޾(100) 24,000 23,000 1,000 23,200
Ʒγΰ(100) 30,000 28,000 2,000 28,500
īɾ(10g) 7,000 6,000 1,000 6,559
Ľõ򿬰(5g) 5,000 4,500 500 5,138
Ź(4) 5,000 4,000 1,000 4,438
ڶ(20) 6,000 6,000 0 6,000
(10) 6,000 4,500 1,500 5,071
Ժ(10) 4,000 3,500 500 3,712
ڱ׸(20) 5,000 4,500 500 4,717
ť(10) 3,000 2,500 500 2,990
Ȱť(1) 1,200 900 300 1,182
Ǯɾ(3.3ml) 26,000 23,000 3,000 24,250
޵𿬰(10g) 7,000 5,900 1,100 6,289
öŸ(34) 13,000 11,000 2,000 11,866
뽺ī(20g) 22,000 18,000 4,000 20,184
ġ(1) 1,000 1,000 0 1,000
ӽ÷(21) 10,000 8,500 1,500 9,205
ͺ(10) 3,500 3,000 500 3,196
ݿ(1ڽ) 3,000 3,000 0 3,000
׶÷糪ƮŸ(6) 8,000 7,000 1,000 7,524
߽Ÿ(120) 70,000 50,000 20,000 60,385
Źĸ(10ĸ) 3,000 2,000 1,000 2,989
Ÿ̾(120) 60,000 50,000 10,000 51,538
տ(60ĸ) 29,000 25,000 4,000 27,600
Ÿ̷ER(6) 3,000 2,500 500 2,750
ٿ(30g) 12,000 9,000 3,000 11,444
(120) 25,000 22,000 3,000 24,991
Ʒ(6) 4,000 3,000 1,000 3,262
ǽõĸ(270ĸ) 110,000 110,000 0 110,000
B(120) 70,000 70,000 0 70,000
׳(10) 3,000 2,500 500 2,778
6̺(10) 3,000 3,000 0 3,000
(60) 230,000 220,000 10,000 223,333
Ⱦ 12,000 10,000 2,000 10,143
̰źĸ(60ĸ) 35,000 30,000 5,000 33,231
Ųť(20) 5,500 4,500 1,000 4,903
λ絹÷(100) 35,000 32,000 3,000 33,297
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ּ: ı 128 SK V1 GL ƮνƼ A 401ȣ
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