| Japanese |
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| Title | 111In-DTPA-D-Phe-octreotideの安全性, 薬物動態, 被曝線量の検討 - 第1相臨床試験報告 - |
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| Subtitle | 技術報告 |
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| Authors | 井上登美夫*, 大竹英則**, 平野恒夫*, 冨吉勝美*, 遠藤啓吾*, 田中孝司***, 清水直容***, 斎藤達雄**** |
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| Authors(kana) | |
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| Organization | *群馬大学医学部核医学教室, **附属病院中央放射線部, ***帝京大学医学部第三内科, ****佐々木研究所附属杏雲堂病院 |
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| Journal | 核医学 |
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| Volume | 32 |
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| Number | 5 |
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| Page | 511-521 |
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| Year/Month | 1995/5 |
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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」111In-DTPA-D-Phe-octreotide(111In-octreotide)の第1相臨床試験として, 安全性, 体内薬物動態および被曝線量の検討を4名の若い成人男性を対象として行った. 本剤投与後に副作用発現はなく, またバイタルサイン, 臨床検査値の有意の変動も認められなかった. 本剤の血漿消失曲線は2相性で, 早期相および遅延期相の平均半減時間は各々9.2分, 2.2時間であった. 本剤投与24時間後までの累積尿中排泄率は平均73%であった. 正常組織の被曝線量としては, 膀胱, 腎臓, 脾臓, 肝臓などが多く, 実効線量当量は3.26±0.43mSv/37 MBq(平均±標準偏差)であった. これらの結果より, 本剤の安全性が確認された. 「I. はじめに」111In-DTPA-D-Phe-octreotide(111In-ペンテトレオチド)はソマトスタチンレセプターに結合するRI標識ソマトスタチン誘導体である. |
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| Practice | 臨床医学：一般 |
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| Keywords | Somatostatin, Octreotide, 111In-DTPA-D-Phe-octreotide. |
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| English |
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| Title | Clinical Evaluation of Safety, Pharmacokinetics and Dosimetry of the Somatostatin Analog 111In-DTPA-D-Phe-Octreotide - Report of the Phase 1 Study - |
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| Subtitle | |
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| Authors | Tomio INOUE*, Hidenori OOTAKE**, Tsuneo HIRANO*, Katsumi TOMIYOSHI*, Keigo ENDO*, Koshi TANAKA***, Naokata SHIMIZU***, Tatsuo SAITO**** |
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| Authors(kana) | |
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| Organization | *Department of Nuclear Medicine, Gunma University School of Medicine, **Division of Central Diagnostic Radiology, Gunma University Hospital, ***Department of Third Internal Medicine, Teikyo University School of Medicine, ****Kyoundo Hospital, Sasaki Institute |
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| Journal | The Japanese Journal of nuclear medicine |
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| Volume | 32 |
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| Number | 5 |
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| Page | 511-521 |
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| Year/Month | 1995/5 |
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| Article | Report |
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| Publisher | THE JAPANESE SOCIETY OF NUCLEAR MEDICINE |
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| Abstract | The safety, pharmacokinetics and dosimetry of the somatostatin analog 111In-DTPA-D-Phe-octreotide (111In-octreotide) were investigated in four young normal volunteers as phase 1 study in Japan. Neither adverse reactions nor significant changes of vital signs and clinical laboratory data were observed after intravenous injection of 111 MBq of 111In octreotide. The plasma clearance curve consisted of fast and slow exponential components with mean half life of 9.2 minutes and 2.2 hours, respectively. Seventy three percent of the injected dose were excreted in the urine by 24 hours after the injection of 111In-octreotide. With respect to the radiation dose to normal tissue, the most important organs were the urinary bladder, the kidney, the spleen and the liver. The effective dose equivalent was calculated as 3.26+-0.43 mSv/37 MBq(mean+-s. d. ). This phase 1 study demonstrated the safety of scintigraphy with 111In-octreotide. |
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| Practice | Clinical medicine |
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| Keywords | Somatostatin, Octreotide, 111In-DTPA-D-Phe-octreotide. |
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