Hinotsu Shiro, Akaza Hideyuki, Isaka Shigeo, Kagawa Susumu, Koiso Kenkichi, Kotake Toshihiko, Machida Toyohei, Matsumura Yosuke, Niijima Tadao, Obata Koji, Ohashi Yasuo, Ohe Hiroshi, Shimazaki Jun, Tashiro Kazuya
Faculty of Medicine, University of Tokyo.
Gan To Kagaku Ryoho. 2002 Jan;29(1):73-80.
A total of 465 patients with primary and multiple or recurrent, stages Ta and T1 superficial bladder cancer were included in this randomized multicenter trial to compare the prophylactic effect by 17 times instillation of 40 mg doxorubicin or 40 mg epirubicin with no instillation after transurethral resection of tumor(s). The primary endpoint was first recurrence after transurethral resection. Endoscopic examination as well as urinary cytology was performed in each case every three months. It became evident that the recurrence rate in the doxorubicin or epirubicin instillation arm was lower that in the no instillation arm. Toxicity was mainly restricted to bladder irritation in about 10% of patients in each instillation arm.
本随机多中心试验纳入了465例原发性、多发性或复发性Ta期和T1期浅表性膀胱癌患者，比较经尿道肿瘤切除术后，40mg阿霉素或40mg表阿霉素17次灌注与不进行灌注的预防效果。主要终点是经尿道切除术后的首次复发。每例患者每三个月进行一次内镜检查和尿液细胞学检查。结果表明，阿霉素或表阿霉素灌注组的复发率低于未灌注组。毒性反应主要局限于各灌注组约10%的患者出现膀胱刺激症状。
