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Title: 表在性膀胱癌再発予防の臨床的研究 --Bleomycin膀注およびBestatin併用比較試験成績の各種統計解析による検討--
Other Titles: Clinical research on prevention of recurrence of superficial bladder cancer--comparative study on clinical efficacy of bleomycin intravesical instillation and bestatin
Authors: 熊本, 悦明  KAKEN_name
塚本, 泰司  KAKEN_name
田宮, 高宏  KAKEN_name
高塚, 慶次  KAKEN_name
古屋, 聖児  KAKEN_name
横山, 英二  KAKEN_name
本間, 昭雄  KAKEN_name
青山, 龍生  KAKEN_name
丹田, 均  KAKEN_name
加藤, 修爾  KAKEN_name
井川, 欣市  KAKEN_name
生垣, 舜二  KAKEN_name
江夏, 朝松  KAKEN_name
大村, 清隆  KAKEN_name
鳥居, 恒明  KAKEN_name
藤田, 征隆  KAKEN_name
水戸部, 勝幸  KAKEN_name
西尾, 彰  KAKEN_name
菊地, 浩吉  KAKEN_name
三宅, 浩次  KAKEN_name
Author's alias: Kumamoto, Yoshiaki
Tsukamoto, Taiji
Tamiya, Takahiro
Takatsuka, Keiji
Furuya, Seiji
Yokoyama, Eiji
Honma, Akio
Aoyama, Tatsuo
Tanda, Hitoshi
Kato, Shuji
Igawa, Kinichi
Ikegaki, Shunji
Enatsu, Choshyo
Ohmura, Kiyotaka
Torii, Tsuneaki
Fujita, Masataka
Mitobe, Katsuyuki
Nishio, Akira
Kikuchi, Kokichi
Miyake, Koji
Keywords: Adolescent
Antibiotics, Antineoplastic/administration & dosage
Bleomycin/administration & dosage
Carcinoma, Transitional Cell/pathology/prevention & control
Chemotherapy, Cancer, Regional Perfusion
Child, Preschool
Drug Therapy, Combination
Follow-Up Studies
Leucine/administration & dosage/analogs & derivatives
Middle Aged
Neoplasm Recurrence, Local/prevention & control
Neoplasm Staging
Urinary Bladder Neoplasms/pathology/prevention & control
Issue Date: Oct-1985
Publisher: 泌尿器科紀要刊行会
Journal title: 泌尿器科紀要
Volume: 31
Issue: 10
Start page: 1861
End page: 1883
Abstract: Objectives and methods of the study: Although superficial bladder carcinoma can be surgically eliminated by TUR, recurrence is common. Various attempts have been made to prevent recurrence, but to date an excellent prophylactic method with few adverse reactions has not been established. We conducted a clinical trial study for prophylaxis of bladder carcinoma recurrence, using intravesical instillation of bleomycin, a drug which cause little local irritation, in combination with bestatin, a recently developed immunomodulator. Bleomycin was selected on the bases of experimental results. That is, in beagle dogs, the 1-hour intravesical instillation of bleomycin gained a drug concentration in the bladder wall of 2.08 micrograms/g, which is approximately 4 times higher than that in the intravenous administration of the same dose. The above bleomycin concentration was thought enough to obtain a good clinical effect. A total of 124 patients were randomly divided into the two treatment groups: An only bleomycin intravesical instillation group (60 mg on each treatment day) (58 patients) and a bleomycin with bestatin (60 mg per every day) group (66 patients). In the 2-year follow-up period the recurrence of bladder carcinoma in the two treatment groups was studied. Analysis of non-recurrence rate by life-table method and Kaplan-Meier method: The non-recurrence rate of the bladder carcinoma every three months was calculated by the life-table and Kaplan-Meier methods. The non-recurrence rate in the bleomycin group was approximately the same as the rates in adriamycin or mitomycin reported in the literature. In the bleomycin + bestatin group, the recurrence rates at 9 months and 12 months were significantly (at P = 0.09 and P = 0.08, respectively) lower, and in addition, even the 2-year overall non-recurrence rate curves showed a nearly significant difference (P = 0.179). Especially in the case of papillary pedunculated tumors, the difference in the non-recurrence rate curves was almost statistically significant (P = 0.104). The stratified analysis on the basis of various tumor factors, were as follows. Pathological grade: Although no differences were found in Grades 1 and 2, the bleomycin + bestatin group had a lower recurrence rate in Grade 3 cases (P = 0.1).(ABSTRACT TRUNCATED AT 400 WORDS)
PubMed ID: 2418659
Appears in Collections:Vol.31 No.10

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