| Japanese |
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| Title | 腎動態イメージング剤99mTc-MAG3注射液の第3相臨床試験 - 他剤との比較による有用性の検討 - |
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| Subtitle | 技術報告 |
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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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| Authors(kana) | |
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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 | 31 |
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| Number | 2 |
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| Page | 183-198 |
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| Year/Month | 1994/2 |
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| Article | 報告 |
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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, 有効性および有用性の検討を目的に, 腎・尿路疾患506例を対象として共同研究による臨床試験を実施した. 本剤の安全性については問題ないと考えられた. 本剤の有効性は, 解析対象497例の99.8%で「有効」以上と判定された. また, 123I-OIH (150例) および99mTc-DTPA (151例) との比較で, 担当医師によりそれぞれ62.0%および45.0%の症例で本剤の方が有効であると判定された. 判定委員会では, 使用薬剤の盲条件下でこれらの薬剤と比較し, 本剤の方が血流画像のみならず経時画像でも画質に優れ, また得られる所見もより信頼性の高いものと判定された. 以上のことから, 本剤は腎・尿路疾患の診断において有用性の高い放射性医薬品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) , Renography, Phase 3 clinical study, 123I-OIH, 99mTc-DTPA. |
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| English |
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| Title | Phase 3 Clinical Study of 99mTc-MAG3 Injectable, a Dynamic Renal Imaging Agent - Comparison with 123I-OIH and 99mTc-DTPA - |
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| Subtitle | Technical Reports |
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| Authors | Kanji TORIZUKA*, Akira ISHIBASHI**, Katsuji IKEKUBO***, Kazutaka YAMAMOTO****, Shigeo NISHIBUCHI***** |
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| Authors(kana) | |
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| Organization | *Fukui Medical School, **School of Medicine, Kitasato University, ***Department of Nuclear Medicine, Kobe City General Hospital, ****Department of Radiology, Fukui Medical School, *****Department of Urology, Fukui Medical School |
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| Journal | The Japanese Journal of nuclear medicine |
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| Volume | 31 |
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| Number | 2 |
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| Page | 183-198 |
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| Year/Month | 1994/2 |
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| Article | Report |
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| Publisher | THE JAPANESE SOCIETY OF NUCLEAR MEDICINE |
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| Abstract | [Summary] A Phase 3 clinical study of 99mTc-mercaptoacetyl glycylglycylglycine (99mTc-MAG3) injectable was performed in 506 patients with renal and/or urinary disorders. The scintigraphic findings and renogram patterns of 99mTc-MAG3 were similar to those of 123I-OIH, and Tmax and T1/2 of the 99mTc-MAG3 renogram correlated with those of 123I-OIH (r=0.62 and r=0.74, respectively) . The clinical efficacy of 99mTc-MAG3, evaluated by the investigators in the same patients, was superior to the efficacy of 123I-OIH and 99mTc-DTPA in 93 of 150 patients (62.0%) and 68 of 151 patients (45%) , respectively. The image quality and the reliability of the scintigraphic findings with 99mTc-MAG3 were superior to those with 123I-OIH and 99mTc-DTPA, which reflect the more abundant photons of 99mTc-MAG3 than those of 123I-OIH and higher renal extraction of 99mTc-MAG3 than those of 99mTc-DTPA, respectively. Neither adverse reactions nor abnormal laboratory findings due to 99mTc-MAG3 administration were observed. These results suggest that 99mTc-MAG3 injectable is safe and a useful radiopharmaceutical for diagnosis of renal and urinary disorders. |
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| Practice | Clinical medicine |
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| Keywords | 99mTc-mercaptoacetyl glycylglycylglycine (99mTc-MAG3) , Renography, Phase 3 clinical study, 123I-OIH, 99mTc-DTPA. |
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