| Japanese |
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| Title | 新しい心筋血流イメージング剤99mTc-Tetrofosmin (PPN1011) 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 | 佐々木康人*, 西村恒彦**, 久保敦司***, 西川潤一*, 分校久志****, 玉木長良*****, 大嶽達* |
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| Authors(kana) | |
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| Organization | *東京大学医学部放射線科, **大阪大学医学部トレーサ解析学, ***慶應義塾大学医学部放射線科, ****金沢大学医学部核医学科, *****京都大学医学部核医学科 |
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| Journal | 核医学 |
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| Volume | 30 |
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| Number | 3 |
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| Page | 257-271 |
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| Year/Month | 1993/3 |
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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」 355例の心疾患患者を対象として, 新しい心筋血流イメージング剤99mTc-Tetrofosmin(PPN1011)の臨床的有用性の評価を目的に多施設共同第III相臨床試験を行った. 1日法, 2日法ともに本剤による心筋SPECT像は201Tl像よりも良質の画像が得られる頻度が高かった. また, 投与後10-30分からの撮像も十分可能であった. 本剤投与に関連性があると思われる副作用は認められず安全性が確認された. 本剤のSPECTによる異常検出率は84.0%で同一症例の201Tl SPECTでは88.4%であった. 画像所見は本剤と201 Tlで約88%の一致率を示し, 心筋血流を反映した所見と考えられた. 冠動脈造影所見との比較でも約74%の病変で一致を示した. 本剤は簡便に標識できる99mTc製剤のため緊急時の対応も可能であり, 急性期の血行再建術前後での血流の改善の評価も可能であった. これらの成績を総合して評価された本剤の臨床的有用性は93.2%(331/355)に認められ, 心筋血流イメージング剤として有用と考えられた. |
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| Practice | 臨床医学：一般 |
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| Keywords | 99mTc-Tetrofosmin, Myocardial perfusion, SPECT, Multicenter Phase III Clinical Trials, 201Tl |
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| English |
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| Title | Evaluation of the Clinical Usefulness of a New Myocardial Imaging Agent, 99mTc-Tetrofosmin (PPN1011) - A Report of Multicenter Phase III Clinical Trials - |
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| Subtitle | Original Articles |
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| Authors | Yasuhito SASAKI*, Tsunehiko NISHIMURA**, Atsushi KUBO***, Junichi NISHIKAWA*, Hisashi BUNKOH****, Nagara TAMAKI*****, Tohru OHTAKE* |
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| Authors(kana) | |
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| Organization | *Department of Radiology, Faculty of Medicine, The University of Tokyo, **Department of Tracer Analysis, School of Medicine, Osaka University, ***Department of Radiology, School of Medicine, Keio University, ****Department of Nuclear Medicine, Faculty of Medicine, Kanazawa University, *****Department of Nuclear Medicine, Faculty of Medicine, Kyoto University |
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| Journal | The Japanese Journal of nuclear medicine |
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| Volume | 30 |
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| Number | 3 |
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| Page | 257-271 |
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| Year/Month | 1993/3 |
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| Article | Original article |
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| Publisher | THE JAPANESE SOCIETY OF NUCLEAR MEDICINE |
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| Abstract | The clinical usefulness of a new myocardial perfusion imaging agent, 99mTc-1,2-bis[bis(2-ethoxyethyl)phosphino]ethane (99mTc-Tetrofosmin, (PPN1011) was evaluated in 355 patients with various heart diseases. Both 1 and 2 day protocols resulted in images that were significantly clearer than those of 201Tl. The absence of significant drug related adverse reaction supported the safety of the agent for clinical use. Regional abnormalities detected by CAG agreed with 99mTc-Tetrofosmin SPECT findings in 74% and with 201Tl SPECT in 78% of this study. Eighty-four percent of an abnormalities were detected with 99mTc-Tetrofosmin SPECT, as compared with those detected with 201Tl SPECT (88.4%). The complete concordance ratio between 99mTc-Tetrofosmin and 201Tl images in segmental analysis was 87-89% at rest and stress. Since 99mTc-Tetrofosmin SPECT was judged clinically useful in 93.2% (331/355) of the patients studied, it is concluded that 99mTc-Tetrofosmin is a promising agent for myocardial perfusion imaging. The simple labeling procedure without heating and cooling is suitable for emergency administration. Reconditioning of myocardial perfusion could be evaluated with 99mTc-Tetrofosmin injection before and after interventional therapy. These are additional features of the agent for clinical use. |
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| Practice | Clinical medicine |
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| Keywords | 99mTc-Tetrofosmin, Myocardial perfusion, SPECT, Multicenter Phase III Clinical Trials, 201Tl |
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