Japanese
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1報) - 各種脳疾患等における安全性および臨床的有効性の検討 -
Subtitle技術報告
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
Authors(kana)
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
Journal核医学
Volume33
Number3
Page293-301
Year/Month1996/3
Article報告
Publisher日本核医学会
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)の各種脳疾患診断における安全性および有効性を検討するために, 全国52施設による多施設共同研究として第3相臨床試験を行った. てんかん, 脳血管障害, 中枢神経変性疾患および精神神経障害などの各種脳疾患患者655例において本剤が投与された. 本剤の安全性については, 自・他覚症状および臨床検査において重篤な副作用はみられなかった. 本剤の有効性に関しては, 解析対象638例中606例(95%)において「きわめて有効」または「有効」と判定された. 本剤の投与量は有効性または後期像の画質との間には関連はみられず, それぞれ患者の病態や機器の性能が大きく影響していることが示唆された. 本剤は安全性に特に大きな問題はなく, 各種脳疾患においてBZRの脳局所分布に関する情報に基づいた有用な診断方法をもたらすことが示唆された.
Practice臨床医学：一般
Keywords123I-Iomazenil, Benzodiazepine receptor, Central nervous system disorders, Phase 3 study, Neuronal damage.
English
TitleA Phase 3 Clinical Trial of 123I - Iomazenil, a New Central - Type Benzodiazepine Receptor Imaging Agent (Part 1) - Report on Clinical Usefulness in Diagnosis of Various Brain Diseases -
SubtitleTechnical Reports
AuthorsKanji 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
Authors(kana)
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
JournalThe Japanese Journal of nuclear medicine
Volume33
Number3
Page293-301
Year/Month1996/3
ArticleReport
PublisherTHE JAPANESE SOCIETY OF NUCLEAR MEDICINE
Abstract[Summary]Iomazenil(IMZ)is a partial inverse agonist of central-type benzodiazepine receptors(BZR) which binds specifically to BZR with high affinity. The safety and clinical effectiveness of 123I-IMZ SPECT in the diagnosis of brain diseases were evaluated in 655 patients with various brain diseases, such as epilepsy, cerebrovascular diseases, degenerative diseases and mental disorders relating to BZR. This was a Phase 3 study conducted as a multicenter trial at 52 collaborating institutions. There were no significant adverse reactions in the clinical symptoms or abnormal laboratory test values. The investigators judged 123I-IMZ SPECT to be effective in 95% of 638 analyzed cases. The injected dose did not correlate with the image quality or the clinical effectiveness of 123I-IMZ SPECT, suggesting that these items depend largely on the characteristics of the apparatus used, the disease or pathology of the patients, rather than the dose. We conclude that 123I-IMZ imaging is safe and provides effective information based on BZR binding which is useful in the diagnosis of various brain diseases.
PracticeClinical medicine
Keywords123I-Iomazenil, Benzodiazepine receptor, Central nervous system disorders, Phase 3 study, Neuronal damage.

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