| Japanese |
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| Title | ヒト免疫グロブリンG - ジエチレントリアミン五酢酸インジウム (111In) (111In - DTPA - IgG) の炎症イメージング剤としての臨床的有用性に関する検討 - 多施設による臨床第III相試験報告 - |
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| Subtitle | 技術報告 |
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| Authors | 久保 敦司*1, 戸辺公子*2, 鈴木謙三*3, 伊藤和夫*4, 遠藤啓吾*5, 宇野公一*6, 間島寧興*7, 丸岡伸*8, 利波紀久*9, 阪原晴海*10, 大塚信昭*11, 増田康治*12, 宮崎知保子*13, 遊佐昌樹*14, 後藤元*15, 島田馨*16 |
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| Authors(kana) | |
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| Organization | *1慶應義塾大学病院放射線科, *2東京大学医科学研究所附属病院放射線科, *3東京都立駒込病院放射線診療科, *4北海道大学医学部核医学講座, *5群馬大学医学部附属病院核医学科, *6千葉大学医学部附属病院放射線科, *7東京都老人医療センター核医学診断科, *8東北大学医学部附属病院放射線科, *9金沢大学医学部附属病院核医学診療科, *10京都大学医学部附属病院核医学科, *11川崎医科大学附属病院核医学科, *12九州大学医学部附属病院放射線科, *13市立札幌病院放射線科, *14国保直営総合病院君津中央病院放射線科, *15東京都立駒込病院呼吸器内科, *16東京専売病院 |
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| Journal | 核医学 |
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| Volume | 34 |
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| Number | 6 |
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| Page | 399-412 |
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| Year/Month | 1997/6 |
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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」炎症イメージング剤として開発された111In-DTPA-IgGの臨床的有用性を評価するために, 感染あるいは炎症が強く疑われる患者145名を対象に第III相臨床試験を実施し, 全症例について本剤の安全性, 有効性および有用性を検討した. 投与後の自他覚症状の発現, 身体所見や臨床検査値の異常変動のうち, 本剤との因果関係が示唆されたのはごく少数例であり, 本剤の高い安全性が示唆された. 施設担当医師により171部位(頭頸部:12, 胸腔:39, 腹腔・骨盤腔:44, 筋・骨格系:62, その他:14)が検討され, 病変の部位に関わらず良好な読影結果が得られ, 判定が保留された18部位を除く153部位に関する感度および特異性は, それぞれ89.8%および85.7%であった. 偽陽性例は5例, 偽陰性例は12例で認められた. 臨床応用に際しては, 頭部静脈洞および肝臓を含めた生理的集積部位の存在, 腸管排泄に留意した上で読影を行うことが非常に重要であると思われた. |
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| Practice | 臨床医学：一般 |
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| Keywords | 111In polyclonal human IgG, Clinical study, Inflammation, Infection. |
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| English |
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| Title | Evaluation of Clinical Utility of 111In - DTPA - IgG Scintigraphy in the Detection of Inflammation / Infection - A Report of Multicenter Phase III Clinical Trials - |
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| Subtitle | Technical Reports |
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| Authors | Atsushi KUBO*1, Kimiko TOBE*2, Kenzo SUZUKI*3, Kazuo ITOH*4, Keigo ENDO*5, Kimiichi UNO*6, Yasuoki MASHIMA*7, Shin MARUOKA*8, Norihisa TONAMI*9, Harumi SAKAHARA*10, Nobuaki OTSUKA*11, Koji MASUDA*12, Chihoko MIYAZAKI*13, Masaki YUSA*14, Hajime GOTOH*15, Kaoru SHIMADA*16 |
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| Authors(kana) | |
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| Organization | *1Department of Radiology, School of Medicine, Keio University, *2Department of Radiology, The Institute of Medical Science, The University of Tokyo, *3Department of Radiology, Toklyo Metropolitan Komagome Hospital, *4Department of Nuclear Medicine, Hokkaido University School of Medicine, *5Department of Nuclear Medicine, School of Medicine, Gunma University, *6Department of Radiology, School of Medicine, Chiba University, *7Department of Nuclear Medicine, Tokyo Metropolitan Geriatric Hospital, *8Department of Radiology, Tohoku University School of Medicine, *9Department of Nuclear Medicine, Kanazawa University School of Medicine, *10Department of Nuclear Medicine, Kyoto University Faculty of Medicine, *11Department of Nuclear Medicine, Kawasaki Medical School, *12Department of Radiology, Kyusshu University Faculty‘of Medicine, *13Department of Radiology, Sapporo City General Hospital, *14Department of Radiology, Kimitsu Central Hospital, *15Department of Pulmonary Diseases, Tokyo Metropolitan Komagome Hospital, *16Tokyo Senbai Hospital |
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| Journal | The Japanese Journal of nuclear medicine |
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| Volume | 34 |
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| Number | 6 |
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| Page | 399-412 |
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| Year/Month | 1997/6 |
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| Article | Report |
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| Publisher | THE JAPANESE SOCIETY OF NUCLEAR MEDICINE |
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| Abstract | [Summary]This is the report of phaseIII study to evaluate the safety and utility of 111In-DTPA-IgG in patients with strongly suspected inflammation/infection. One hundred and forty five patients with suspected sites of inflammation/infection were enrolled in the study. Only a few adverse experiences in one patient were reported, which were interpreted as having a possible relationship to the agent. A total of 171 suspected sites(12 in head and neck, 39 in thorax, 44 in abdomen and pelvis, 62 in musculoskeletal system, and 14 in other regions)were evaluated by investigators at each institute. Out of 171 sites, 18 were determined to be unevaluable, and 12 false negative and 5 false positive cases were obsereved. Overall sensitivity and specificity was 89.8% and 85.7%, respectively, and the agent proved to be effective in detecting lesions anywhere throughout the body. The analysis of data from this Phase III study indicates that 111In-DTPA-IgG is well-tolerated in patients and effective in determining focal sites of inflammation/infection although the physiological accumulation in some tissues such as the sinus or liver and possible excretion into the gastrointestinal tract may make it difficult to localize lesions. |
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| Practice | Clinical medicine |
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| Keywords | 111In polyclonal human IgG, Clinical study, Inflammation, Infection. |
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