| Japanese |
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| Title | 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) (99mTc-MAG3) の第I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 | *北里大学病院放射線科, **北里大学病院泌尿器科, ***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 | 2 |
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| Page | 181-188 |
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| Year/Month | 1993/2 |
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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」腎動態イメージングおよびレノグラフィによる腎動態機能診断薬として開発された. 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)(99mTc-MAG3)の安全性と体内薬物動態を評価するため, 健常人ボランティア3名を対象に, 第I相臨床試験を実施した. 本剤の投与による自他覚症状の発現, 身体所見, 臨床検査値の変動は認められず, 本剤は安全性の高い薬剤であると考えられた. 本剤は投与後速やかに腎臓へ移行し, 直ちに尿中へ排泄された. 本剤投与直後より腎動態イメージングを施行し, 良好な腎動態イメージおよびレノグラムを得た. レノグラムのピークタイムは投与後およそ3分, ピークカウントに対する投与20分後の腎残存カウントの割合は19.3%であった. 投与後30分までに投与量の77.1±3.5%, 3時間までに94.1±2.7%が尿中に排泄された. MIRD法により算出した本剤による体内吸収線量は, 最も高い膀胱においても5.78mGy/200MBqであり, 核医学検査として十分許容範囲内であった. したがって, 本剤は腎動態機能診断薬として有望な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-MAG3, Kidney, Renal imaging, Renogram |
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| English |
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| Title | Phase I Clinical Study of 99mTc-MAG3 |
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| Subtitle | Summary |
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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 | 2 |
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| Page | 181-188 |
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| Year/Month | 1993/2 |
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| Article | Original article |
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| Publisher | THE JAPANESE SOCIETY OF NUCLEAR MEDICINE |
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| Abstract | A phase I study was performed in three normal volunteers to evaluate the safety and biodistribution of 99mTc-MAG3 which was developed as a renal scintigraphic and renographic dynamic function agent. There was no significant adverse reaction, change in vital signs and clinical laboratory data by the injection of 99mTc-MAG3. Therefore it is assumed that the safety of the agent is high. Clearance of injected 99mTc-MAG3 from blood was rapid and the agent was excreted into urine. Immediately after administration of the agent, renal dynamic scintigraphy was performed and provided better quality of images and renograms. Peak time in the renogram was about 3 min post injection and residual count rate to the peak count at 20 min after injection was 19.3%. Cumulative urinary excretion during the first 30 min and 3 hr expressed in %Dose was 77.1 +- 3.5% and 94.1 +- 2.7%, respectively. Radiation dose estimates calculated with MIRD method, in the highest organ, bladder, is 5.78 mGy/200 MBq, which seems to be within permissible range for routine examination in nuclear medicine. It is concluded that 99mTc-MAG3 is a safe and promissing radiopharmaceutical in diagnosis of renal dynamic function. |
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| Practice | Clinical medicine |
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| Keywords | 99mTc-MAG3, Kidney, Renal imaging, Renogram |
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