| Japanese |
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| Title | 中枢性ベンゾジアゼピン受容体イメージング剤123I - イオマゼニルの第3相臨床試験 (第3報) - てんかんにおける臨床的有用性の検討 - |
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| Subtitle | 技術報告 |
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| Authors | 鳥塚莞爾*1, 上村和夫*2, 融道男*3, 篠原幸人*4, 西村恒彦*5, 米倉義晴*6, 中川原譲二*7, 松田博史*8, 坂井文彦*9, 松田一己*10, 福山秀直*11, 森本清*12 |
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| Authors(kana) | |
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| Organization | *1福井医科大学(現 ; 京都大学名誉教授), *2秋田県立脳血管研究センター, *3東京医科歯科大学神経精神科, *4東海大学第五内科(神経内科), *5大阪大学トレーサ情報解析学講座, *6京都大学脳病態生理学講座(現 ; 福井医科大学高エネルギー医学研究センター), *7中村記念病院脳神経外科, *8国立精神神経センター武蔵病院放射線診療部, *9北里大学内科, *10国立療養所静岡東病院(てんかんセンター)脳神経外科, *11京都大学神経内科(現 ; 脳病態生理学講座), *12香川医科大学精神神経科 |
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| Journal | 核医学 |
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| Volume | 33 |
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| Number | 3 |
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| Page | 319-328 |
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| Year/Month | 1996/3 |
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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」中枢性ベンゾジアゼピン受容体(BZR)に特異的に結合する123I-イオマゼニル(本剤)の第3相臨床試験を実施し, てんかん患者121例(部分てんかん106例, 全汎てんかん15例)を対象にてんかん焦点診断における本剤の有用性を検討した. MRI/CTで異常がなかった24例中20例において本剤後期像で局所性の異常を認めたが, 血流像で異常がみられたのは, これら20例中16例のみであった. 部分てんかんにおいて後期像の異常所見部位は, 発作症状, 発作間歇期脳波およびMRI/CTと比較し得た症例のそれぞれ76%, 70%および96%の症例で推定された焦点部位と一致または部分一致を示し, また, これら3者の所見による焦点部位が一致した症例の92%, 発作時脳波による焦点部位とは72%の症例で一致または部分一致を示した. 本剤後期像は, これらいずれの比較においても有意ではないが血流像の一致率を上回った. さらに, 手術で確定し得た焦点部位において, 血流像で異常のない領域での焦点の描出に優れていた. 本剤は, 脳内BZRの分布に基づいた, 新しいてんかん焦点検索の手段となり得ることが示された. |
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| Practice | 臨床医学：一般 |
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| Keywords | 123I-Iomazenil, Benzodiazepine receptor, Epilepsy, Phase 3 study. |
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| English |
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| Title | A Phase 3 Clinical Trial of 123I - Iomazenil, a New Central - Type Benzodiazepine Receptor Imaging Agent (Part 3) - Report on Clinical Usefulness in Epilepsy - |
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| Subtitle | Technical Reports |
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| Authors | Kanji TORIZUKA*1, Kazuo UEMURA*2, Michio TORU*3, Yukito SHINOHARA*4, Tsunehiko NISHIMURA*5, Yoshiharu YONEKURA*6, Jyoji NAKAGAWARA*7, Hiroshi MATSUDA*8, Fumihiko SAKAI*9, Kazumi MATSUDA*10, Hidenao FUKUYAMA*11, Kiyoshi MORIMOTO*12 |
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| Authors(kana) | |
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| Organization | *1Fukui Medical School(Currently Professor Emeritus, Kyoto University), *2Akita Research Institute for Brain and Blood Vessels, *3Department of Psychiatry, Tokyo Medical and Dental University, *4Department of Neurology, Tokai University, *5Department of Tracer Kinetics, Osaka University, *6Department of Brain Pathophysiology, Kyoto University(currently Biomedical Imaging Research Center, Fukui Medical School), *7Department of Neurosurgery, Nakamura Memorial Hospital, *8Department of Radiology, National Center Hospital for Mental, Nervous, and Muscular Disorders, NCNP, *9Department of Internal Medicine, Kitasato University, *10Department of Neurosurgery, National Epilepsy Center, Shizuoka-Higashi Hospital, *11Department of Neurology(currently Department of Brain Pathophysiology), Kyoto University, *12Department of Neuropsychiatry, Kagawa Medical School |
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| Journal | The Japanese Journal of nuclear medicine |
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| Volume | 33 |
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| Number | 3 |
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| Page | 319-328 |
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| Year/Month | 1996/3 |
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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 trial of 123I-Iomazenil(IMZ), a tracer which binds specifically to central-type benzodiazepine receptors(BZR), was performed, and the clinical usefulness of IMZ was evaluated in 121 patients with epilepsy(106 cases with partial epilepsy and 15 cases with generalized epilepsy). A regional abnormality in the BZR distribution was detected in late IMZ images in 20 of 24 cases without abnormal MRI and/or X-ray CT findings. Moreover, only 16 of these 20 cases showed abnormal findings in the cerebral blood flow(CBF)images. In partial epilepsy, abnormal regions in late IMZ images agreed or partially agreed with epileptic foci estimated from the clinical symptoms of epileptic seizures, interictal EEG, and MRI and/or X-ray CT findings in 76%, 70% and 96% of the cases detected. These regions also agreed or partially agreed with the estimated epileptic foci in 92% of the cases with foci estimated by combination of those three methods and in 72% of those estimated by ictal EEG. The agreement or partial agreement rates of late IMZ images with each of the other methods were higher than those of CBF images, although the differences were not significant. For surgically-proven epileptic foci without any abnormality in the CBF image, abnormal regions were detected in late IMZ images. These findings suggest that IMZ SPECT is a useful new tool for detecting epileptic foci based on the distribution of BZR in the brain. |
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| Practice | Clinical medicine |
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| Keywords | 123I-Iomazenil, Benzodiazepine receptor, Epilepsy, Phase 3 study. |
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