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タイトル: | 非ステロイド性抗アンドロゲン剤ビカルタミド(Casodex)の前立腺癌患者における第1相臨床試験 |
その他のタイトル: | Phase I study of bicalutamide (Casodex), a nonsteroidal antiandrogen in patients with prostatic cancer |
著者: | 古武, 敏彦 ![]() 宇佐美, 道之 ![]() 井坂, 茂夫 ![]() 島崎, 淳 ![]() 大石, 賢二 ![]() 吉田, 修 ![]() 大園, 誠一郎 ![]() 岡島, 英五郎 ![]() 金武, 洋 ![]() 斉藤, 泰 ![]() 塚越, 茂 ![]() 赤座, 英之 ![]() 小磯, 謙吉 ![]() 亀山, 周二 ![]() 本間, 之夫 ![]() 阿曽, 佳郎 ![]() 中野, 悦次 ![]() 奥山, 明彦 ![]() 内藤, 誠二 ![]() 熊澤, 浮一 ![]() 仁井谷, 久暢 ![]() 田口, 鐵男 ![]() |
著者名の別形: | KOTAKE, Toshihiko USAMI, Michiyuki ISAKA, Shigeo SHIMAZAKI, Jun OISHI, Kenji YOSHIDA, Osamu OZONO, Sei-ichiro OKAJIMA, Eigoro KANETAKE, Hiroshi SAITOH, Yutaka TSUKAGOSHI, Shigeru AKAZA, Hideyuki KOISO, Kenkichi KAMEYAMA, Shuji HONMA, Yukio ASO, Yoshio NAKANO, Etsuji OKUYAMA, Akihiko NAITO, Seiji KUMAZAWA, Joichi NIITANI, Hisanobu TAGUCHI, Tetsuo |
キーワード: | Prostatic cancer Antiandrogen Bicalutamide Phase I study |
発行日: | Feb-1996 |
出版者: | 泌尿器科紀要刊行会 |
誌名: | 泌尿器科紀要 |
巻: | 42 |
号: | 2 |
開始ページ: | 143 |
終了ページ: | 153 |
抄録: | 1)登録症例は16例で, 全例が適格例であった. 2)副作用は16例中8例に認められたが, 軽度で, 臨床上特に問題はなかった.乳房圧痛, 乳房腫脹等の副作用が50mg群で1例, 80mg群で3例及び100mg群で2例に認められた. 3)有効性に関しては, 各投与群の1例ないし2例において, PR以上の抗腫瘍効果が認められた.又, 排尿困難, 排尿痛, 夜間頻尿の改善がみられた. 4)血清中ホルモンでは, LH, FSH, testosterone及びestradiol濃度の上昇が認められた A phase I study (open trial) of bicalutamide (Casodex), a non-steroidal antiandrogen, was conducted on 16 patients with prostatic cancer (stage C to D). The patients were given 10, 30, 50, 80 or 100 mg of bicalutamide orally daily for 12 weeks. Adverse reactions were observed in 8 out of 16 patients, but almost all were mild. Breast pain, gynecomastia and hot flushes were observed in 6 patients. Adverse reactions regarding liver function tests were observed in 3 patients. These were increased glutamic-oxalacetic transaminase (GOT), glutamic-pyruvic transaminase (GPT), alkaliphosphatase (AL-P) or gamma guanosine 5'-triphosphate (gamma-GTP). However, during or after the treatment period the elevated values were reversed to the pretreatment level. In terms of efficacy, anti-tumor effect was observed in 1 or 2 patients at each dose. Serum concentrations of luteinizing hormone (LH), follicle stimulating hormone (FSH), testosterone and estradiol increased during treatment. Plasma concentrations of the R (-) enantiomer, which has antiandrogenic activity, reached the steady state 6-8 weeks after the initiation of treatment; its apparent plasma elimination half-life observed following repeated administration was 8.4 +/- 1.1 days. In conclusion, bicalutamide (10-100 mg od) is considered to be tolerated well enough to be administered to patients with prostatic cancer and has shown evidence of anti-tumor effect. |
URI: | http://hdl.handle.net/2433/115668 |
PubMed ID: | 8712091 |
出現コレクション: | Vol.42 No.2 |
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