| Japanese |
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| Title | 99mTc-ECDの第I相臨床試験 |
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| Subtitle | 原著 |
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| Authors | 久保敦司*, 中村佳代子*, 塚谷泰司*, 三宮敏和*, 清水正三*, 横山邦彦*, 橋本省三*, 鳥塚莞爾** |
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| Authors(kana) | |
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| Organization | *慶應義塾大学病院放射線科, **福井医科大学学長 |
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| Journal | 核医学 |
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| Volume | 29 |
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| Number | 8 |
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| Page | 1019-1027 |
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| Year/Month | 1992/8 |
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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」局所脳血流シンチグラフィ製剤として開発された99mTc-ECDの安全性と体内薬物動態を評価するため, 健常人ボランティア3名を対象に, 第I相臨床試験を実施した. 本剤の投与による自他覚症状の発現, 身体所見, 臨床検査値の変化は認められず, 安全性の高い薬剤であると考えられた. 本剤は投与後速やかに脳へ集積し, 1分以内に最大集積を示し, その後, きわめてゆっくりと脳からwash-outされた. 投与後5分で投与量の5.4±0.5%, 65分で5.0±0.3%が脳内に保持された. 脳以外の臓器および血中からの消失は速やかであった. 主要排泄経路は腎-尿路系であり, 投与後90分までに投与量の60.2±7.3%, 24時間までに88.5±10.3%が尿中に排泄された. MIRD法により算出した本剤による吸収線量は, 投与2.5時間後に排尿した場合, 最も高い膀胱においても0.073mGy/MBqであり, 核医学検査として十分許容範囲内であった. 本剤投与後30分, 90分, 150分の時点にSPECTを施行し, 鮮明な健常人局所脳血流画像を得た. 本剤は局所脳血流シンチグラフィ製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-ECD, Brain, SPECT, Regional cerebral blood flow. |
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| English |
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| Title | Phase I Clinical Study of 99mTc-ECD |
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| Subtitle | Original Articles |
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| Authors | Atsushi KUBO*, Kayoko NAKAMURA*, Yasushi TSUKATANI*, Toshikazu SANMIYA*, Shozo SHIMIZU*, Kunihiko YOKOYAMA*, Shozo HASHIMOTO*, Kanji TORIZUKA** |
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| Authors(kana) | |
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| Organization | *Department of Radiology, Keio University Hospital, **Fukui Medical School |
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| Journal | The Japanese Journal of nuclear medicine |
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| Volume | 29 |
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| Number | 8 |
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| Page | 1019-1027 |
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| Year/Month | 1992/8 |
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| Article | Original article |
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| Publisher | THE JAPANESE SOCIETY OF NUCLEAR MEDICINE |
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| Abstract | [Summary]A phase I clinical study of 99mTc-L, L-ethyl cysteinate dimer (99mTc-ECD) was carried out in 3 normal volunteers. There was no significant change in vital signs and laboratory parameters attributing to the radiopharmaceutical. 99mTc-ECD was rapidly taken up by the brain, reaching the maximum peak activity within 1 min after the injection and remained relatively constant over several hours. The brain uptake of 99mTc-ECD at 5 min was 5.4+-0.5% which decreased to 5.0+-0.3% by 65 min. 99mTc-ECD cleared rapidly from other organs. The primary excretion route was through the kidneys. Cumulative 99mTc activity in the urine at 90 min and 24 hr were 60.2+-7.3% and 88.5+-10.3%, respectively. The critical organ was the bladder wall with an estimated radiation dose of 0.073 mGy/MBq, which was acceptable value. Clear SPECT images were obtained at 30, 90 and 150min postinjection. In conclusion, 99mTc-ECD is a safe and promising radiopharmaceutical for the evaluation of regional cerebral blood flow. |
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| Practice | Clinical medicine |
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| Keywords | 99mTc-ECD, Brain, SPECT, Regional cerebral blood flow. |
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