| Japanese |
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| Title | 局所脳血流イメージング剤99mTc-ECDの臨床的有用性の検討 - 多施設による第III相臨床試験 - |
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| Subtitle | 原著 |
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| Authors | 米倉義晴*, 佐々木康人**, 久保敦司***, 棚田修二****, 百瀬敏光**, 鳥塚莞爾***** |
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| Authors(kana) | |
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| Organization | *京都大学医学部脳病態生理学講座, **東京大学医学部附属病院放射線科, ***慶應義塾大学病院放射線科, ****愛媛大学医学部附属病院放射線科, *****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 | 4 |
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| Page | 397-410 |
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| Year/Month | 1993/4 |
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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」新しい局所脳血流イメージング剤である99mTc-ECDの安全性, 有効性, 有用性の検討を目的とし, 脳血管障害, 脳機能障害患者521例を対象に全国35施設の共同研究により第III相臨床試験を実施した. 有効性解析対象510例中, 486例(95.3%)において臨床診断に有効な情報が得られ, 444例(87.1%)が「きわめて有用」または「有用」と判定された. 99mTc-HM-PAOとの比較では, 異常所見の検出率は同等であったが, 本剤の方がより鮮明な画像が得られ, また, 集積異常部位がより大きく, コントラストが強く描出される症例が多かった. 本剤は安全性に問題はなく, 局所脳血流イメージング剤として脳血管障害および脳機能障害の診断に有用な放射性医薬品であることが確認された. |
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| Practice | 臨床医学：一般 |
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| Keywords | 99mTc-ECD, Brain, SPECT, Regional cerebral blood flow, Milti-center clinical trial. |
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| English |
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| Title | Clinical Usefulness of 99mTc-ECD - A Multicenter Phase 3 Study - |
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| Subtitle | Original Articles |
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| Authors | Yoshiharu YONEKURA*, Yasuto SASAKI**, Atsushi KUBO***, Shuji TANADA****, Toshimitsu MOMOSE**, Kanji TORIZUKA***** |
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| Authors(kana) | |
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| Organization | *Department of Brain Pathophysiology, Faculty of Medicine, Kyoto University, **Department of Radiology, Faculty of Medicine, University of Tokyo, ***Department of Radiology, Keio University Hospital, ****Department of Radiology, Faculty of Medicine, Ehime University, *****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 | 4 |
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| Page | 397-410 |
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| Year/Month | 1993/4 |
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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 3 clinical study of a newly developed brain perfusion agent, 99mTc-L, L-ethyl cysteinate dimer (99mTc-ECD), was performed in 521 cases of cerebrovascular diseases and impairment of brain function to evaluate the safety, effectiveness and usefulness of the agent as a multi-center study involving 35 institutions in Japan. Out of 510 cases evaluated for the clinical usefulness, valuable information for clinical diagnosis was obtained in 486 cases (95.3%), and 444 cases (87.1%) were judged as "extremely useful" or "useful". Although the positive ratio of abnormalities detected by the agent was as same as that of 99mTc-hexamethyl-propyleneamine oxime (99mTc-HM-PAO), the abnormal regions detected by the agent had tendency to be larger in size and to have higher contrast than those detected by 99mTc-HM-PAO. It is concluded that 99mTc-ECD is a safe and useful radiopharmaceutical as a brain perfusion agent for the diagnosis of cerebrovascular diseases and impairment of brain function. |
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| Practice | Clinical medicine |
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| Keywords | 99mTc-ECD, Brain, SPECT, Regional cerebral blood flow, Milti-center clinical trial. |
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