| Japanese |
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| Title | 腎動態イメージング剤99mTc-MAG3注射液の第1相臨床試験 - 健常成人男子における安全性および体内動態の検討 - |
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| Subtitle | 原著 |
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| Authors | 池窪勝治*, 日野恵*, 伊藤秀臣*, 山本和高**, 鳥塚莞爾*** |
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| Organization | *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 |
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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 | 507-516 |
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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」腎動態シンチグラフィ用製剤として開発された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)の安全性および体内動態を検討するために, 健常成人男子3名を対象に第1相臨床試験を実施した. 投与量はいずれも370MBqであった. 本剤に起因すると考えられる副作用および臨床検査値の異常変動は認められなかった. 99mTc-MAG3は静脈内投与後, 急速に腎に集積し, 速やかに尿中に排泄された. 全身像において肝臓, 胆のうおよび腸管の描出が認められたが, 集積率はいずれの臓器でも投与量の2%以下と低く, 本剤により腎/バックグラウンド比が高い良好なシンチグラムおよびレノグラムが得られた. 本剤による吸収線量は123I-OIH, 99mTc-DTPAと比較して低かった. 以上, 本剤は安全性に問題はなく, 腎動態シンチグラフィ用製剤に適した薬物動態を示したことから, 腎・尿路疾患の診断に有用な放射性医薬品であることが示唆された. |
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| Practice | 臨床医学：一般 |
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| Keywords | 99mTc-mercaptoacetylglycylglycylglycine (99mTc-MAG3), Renal imaging, Renogram, Phase I study. |
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| English |
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| Title | The Phase I Study of 99mTc-MAG3 Injection, a Dynamic Renal Imaging Agent - Evaluation of Its Safety and Biodistribution in Normal Volunteers - |
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| Subtitle | Original Articles |
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| Authors | Katsuji IKEKUBO*, Megumu HINO*, Hidetomi ITO*, Kazutaka YAMAMOTO**, Kanji TORIZUKA*** |
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| Authors(kana) | |
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| Organization | *Department of Nuclear Medicine, Kobe City General Hospital, **Department of Radiology, Fukui Medical School, ***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 | 507-516 |
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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]The phase I study of 99mTc-mercaptoacetylglycylglycylglycine (99mTc-MAG3) injection, which was developed as a radiopharmaceutical for dynamic renal scintigraphy, was performed in three normal volunteers. After intravenous administration of 370 MBq of 99mTc-MAG3 injection, its safety and biodistribution were evaluated. Neither adverse reaction nor abnormal clinical laboratory findings due to 99mTc-MAG3 administration were recognized. Immediately after injection, 99mTc-MAG3 was rapidly accumulated to the kidney and excreted to urine. The liver, gallbladder and intestine were visualized in the whole body images, but each of the percent injected dose in these organs was less than 2%. Excellent renal scintigrams and renograms with high kidney-to-background ratios were obtained. The estimated absorption doses from 99mTc-MAG3 injection were lower than those from 123I-ortho iodo hippurate (123I-OIH) and 99mTc-diethylene triamine pentaacetic acid (99mTc-DTPA). The results suggest that 99mTc-MAG3 injection is useful to evaluate renal functions because of the pharmacokinetic property suitable for renal dynamic scintigraphy. |
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| Practice | Clinical medicine |
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| Keywords | 99mTc-mercaptoacetylglycylglycylglycine (99mTc-MAG3), Renal imaging, Renogram, Phase I study. |
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