Glucagon（グルカゴン G ノボ注射用 1 mg）の臨床評価

志村木綿子; 眞榮田紀子; 土屋博司; 片倉勉; 新井寿久; 石橋健次

薬理と治療

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Glucagon（グルカゴン G ノボ注射用 1 mg）の臨床評価

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Authors: 志村木綿子¹, 眞榮田紀子¹, 土屋博司², 片倉勉¹, 新井寿久³, 石橋健次⁴

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Affiliations:

1 ノボノルディスクファーマ株式会社クオリティー・マネジメント本部製造販売後調査部;

2 ノボノルディスクファーマ株式会社クオリティー・マネジメント本部製造販売後調査部 , ノボノルディスクファーマ株式会社クオリティー・マネジメント本部;

3 エーザイ株式会社臨床研究センター育薬企画部;

4 エーザイ株式会社医薬統括部

Source: 薬理と治療 Volume 37, Issue 9, 763 - 771 (2009)

Publisher: ライフサイエンス出版

Abstract

Treatment outcome research was conducted to investigate the safety and efficacy of GlucagonG Novo at the real practice setting in post−marketing. 4411 subjects were registeredfrom 381 medical institutions all over Japan, and 4286 cases for safety analysis and 4196cases for efficacy analysis were evaluated. The incidence of adverse reaction was 0.91％（39／4282）, which was lower than it reported in clinical trials before the approval（10.26％）. Theefficacy rate in effect−efficacy was 93.8−100％, which was comparable to it reported in clinicaltrials before the approval. These results suggest Glucagon G Novo is safe and efficaciousdrug in the examination and treatment implemented based on its effect−efficacy.（Jpn Pharmacol Ther 2009；37：763−71）KEY WORDS Glucagon G Novo, Post−marketing surveillance, Safety, Efficacy

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薬理と治療

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