| Japanese |
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| Title | 99mTc-MAG3の臨床的有用性の検討 - 24施設による第III相臨床試験 - |
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| Subtitle | 原著 |
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| Authors | 石井勝己*, 石橋晃**, 鳥塚莞爾*** |
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| Authors(kana) | |
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| Organization | *北里大学医学部放射線科, **泌尿器科, ***福井医科大学 |
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| Journal | 核医学 |
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| Volume | 30 |
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| Number | 5 |
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| Page | 517-528 |
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| Year/Month | 1993/5 |
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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99mTc標識腎動態機能イメージング剤であるメルカプトアセチルグリシルグリシルグリシンテクネチウム(99mTc-MAG3)の臨床的有用性を評価するため, 腎および尿路疾患を有する患者357例を対象に, 全国24施設の共同研究による第III相臨床試験を実施した. 本剤を投与した全例について「安全性に問題なし」と判定され, 本剤の安全性の高さが確認された. 有用性解析症例347例のうち, 担当医による有用性の判定により全例(100%)が「きわめて有用」あるいは「有用」と評価され, 本剤の優れた有用性が確認された. また, 判定委員会による総合的有効性の判定では346例(99.7%)が「きわめて有効」あるいは「有効」と評価され, 本剤の優れた有効性が確認された. 判定委員会によるBlind readingでのヨウ化(123I)ヒプル酸ナトリウム(123I-OIH)との比較検討では, 本剤の画質の方がより鮮明であり, 腎・尿路機能情報に関する有効性がより優れていると判定された. 総合的には153例中147例(96.1%)で本剤の方が有効性が高いと判定された. 本剤は日常の核医学検査に安全で有効な放射性腎動態機能診断薬であると結論づけられた. |
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| Practice | 臨床医学：一般 |
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| Keywords | Multicenter clinical trial, 99mTc-MAG3, Kidney, Renal imaging, Renogram, 123I-OIH. |
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| English |
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| Title | Clinical Usefulness of 99mTc-MAG3 - A Multicenter Phase III Study - |
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| Subtitle | Original Articles |
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| Authors | Katsumi ISHII*, Akira ISHIBASHI**, Kanji TORIZUKA*** |
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| Authors(kana) | |
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| Organization | *Department of Radiology, Kitasato University School of Medicine, **Department of Urology, Kitasato University School of Medicine, ***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 | 5 |
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| Page | 517-528 |
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| Year/Month | 1993/5 |
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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 multicenter clinical trial of 99mTc-mercaptoacetylglycylglycylglycine (99mTc-MAG3), a new 99mTc-labeled renal scintigraphic and renographic dynamic functional agent, was performed to evaluate its clinical usefulness at 24 hospitals. The study was performed as a phase III clinical trial and total 357 patients with renal or urinary disorders were examined. There was no adverse reactions in all patients therefore administration agent was judged to be safe by the investigators. 99mTc-MAG3 was proved and concluded to have a superior effectiveness by the investigators in all 347 patients, and by the committee composed of eight representative investigators in 346 patients (99.7%). 99mTc-MAG3 gives a good quality of images of renal, perfusion phase and function-excretory phase as well as functional informations in comparison with 123I-OIH. The committee decided that 99mTc-MAG3 had a superior effectiveness than 123I-OIH in 147 out of 153 cases (96.1%). It is concluded that 99mTc-MAG3 is a safe and effective radiopharmaceutical for routine use in diagnosis of renal dynamic function. |
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| Practice | Clinical medicine |
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| Keywords | Multicenter clinical trial, 99mTc-MAG3, Kidney, Renal imaging, Renogram, 123I-OIH. |
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