| Japanese |
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| Title | 腎動態イメージング剤99mTc-MAG3注射液の第2相臨床試験 - 安全性, 有効性および至適投与量の検討 - |
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| Subtitle | 《原著》 |
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| Authors | 鳥塚莞爾*, 石橋晃**, 池窪勝治***, 山本和高****, 西淵繁夫***** |
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| Organization | *福井医科大学, **北里大学病院, ***神戸市立中央市民病院核医学科, ****福井医科大学放射線科, *****福井医科大学泌尿器科 |
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| Journal | 核医学 |
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| Volume | 30 |
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| Number | 11 |
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| Page | 1379-1392 |
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| Year/Month | 1993/11 |
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| Article | 原著 |
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| Publisher | 日本核医学会 |
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| Abstract | 「要旨」 新しい腎動態イメージング剤99mTc-メルカプトアセチルグリシルグリシルグリシン(99mTc-MAG3)注射液(以下, 本剤)の安全性, 有効性および至適投与量の検討を目的に, 腎・尿路疾患110例を対象とした第2相臨床試験を実施した. 本剤の安全性については特に問題ないと考えられた. 本剤の有効性は, 解析対象症例97例の99%で「有効」以上と判定された. 至適投与量の検討は92.5〜555MBqで実施したが, 92.5MBqでは血流画像の画質が十分でなく, また, 腎血流に関する情報および所見の信頼性が低いことから過少と考えられた. したがって, 本剤の投与量は370MBqを標準とし, 経時画像を中心とした情報を得る場合には185MBqの投与でもよく, 血流情報を特に重視する場合には555MBqの投与が望ましいと考えられた. 以上のことから, 本剤は安全性に問題なく, 腎・尿路疾患の診断に有効であると考えられた. |
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| Practice | 臨床医学：一般 |
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| Keywords | 99mTc-mercaptoacetyl glycylglycylglycine (99mTc-MAG3), Renal imaging agent, Renography, Phase 2 clinical study, Optimal dose. |
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| English |
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| Title | A Phase 2 Clinical Study of 99mTc-MAG3 Injectable a Dynamic Renal Imaging Agent - Evaluation of Its Safety, Effectiveness and Optimal Dose - |
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| Subtitle | Original Articles |
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| Authors | Kanji TORIZUKA1, Akira ISHIBASHI2, Katsuji IKEKUBO3, Kazutaka YAMAMOTO4, Shigeo NISHIBUCHI5 |
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| Authors(kana) | |
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| Organization | 1Fukui Medical School, 2School of Medicine, Kitasato University, 3Department of Nuclear Medicine, Kobe City General Hospital, 4Department of Radiology, Fukui Medical School, 5Department of Urology, Fukui Medical School |
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| Journal | The Japanese Journal of nuclear medicine |
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| Volume | 30 |
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| Number | 11 |
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| Page | 1379-1392 |
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| Year/Month | 1993/11 |
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| Article | Original article |
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| Publisher | THE JAPANESE SOCIETY OF NUCLEAR MEDICINE |
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| Abstract | [Summary] A phase 2 clinical study of 99mTc-mercapto acetyl glycylglycylglycine (99mTc-MAG3) injectable, a new dynamic renal imaging agent, was performed in 110 patients with renal and/or urinary disorders to evaluate the safety, efficacy and optimal dose of this agent. Neither adverse reactions nor abnormal laboratory findings due to intravenous administration of 99mTc-MAG3 were observed. The investigators evaluated the clinical efficacy of 99mTc-MAG3 was to be effective in 96 of 97 cases. Among the doses of 92.5 MBq, 185 MBq, 370 MBq and 555 MBq, the dose of 92.5 MBq was not large enough to provide adequate-quality blood flow images or reliable information for evaluation of the renal blood flow. It was concluded that the optimal dose range of 99mTc-MAG3 was 185-555 MBq with 370 MBq as the standard dose. Also, we surmise that 555 MBq is especially recommendable when detailed blood flow information is required. These results indicate that 99mTc-MAG3 injectable is useful for the diagnosis of renal and urinary disorders. |
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| Practice | Clinical medicine |
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| Keywords | 99mTc-mercaptoacetyl glycylglycylglycine (99mTc-MAG3), Renal imaging agent, Renography, Phase 2 clinical study, Optimal dose. |
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