Matsumura Y, Akaza H, Isaka S, Kagawa S, Koiso K, Kotake T, Machida T, Niijima T, Obata K, Ohashi Y
Department of Urology, Kobe West City Hospital, Japan.
Cancer Chemother Pharmacol. 1992;30 Suppl:S10-4. doi: 10.1007/BF00686934.
A multicentric randomised trial was conducted for the purpose of investigating the efficacy of intravesical chemoprophylaxis of superficial bladder cancers. A total of 443 patients (number of evaluable patients, 284) were registered from July 1987 to December 1989 and randomised into 3 groups. Group A received 21 intravesical instillations of Adriamycin (ADM) at 20 mg/40 ml physiological saline for 2 years after undergoing transurethral resection (TUR); group B was given the same dose as group A but received 6 intravesical instillations for 2 weeks before undergoing TUR; and group C served as a control and underwent TUR only. Better prophylactic effects were obtained in group A. The overall non-recurrence rates calculated for groups A and B differed significantly (P less than 0.05) on day 240, and those determined for groups A and C were also significantly different (P less than 0.01) on day 480. No benefit was obtained using intravesical instillation prior to TUR (group B). The major side effects encountered were pollakisuria and miction pain, which occurred in 32% of the patients in group A and in 52% of those in group B.
为了研究浅表性膀胱癌膀胱内化疗预防的疗效,开展了一项多中心随机试验。1987年7月至1989年12月共登记了443例患者(可评估患者数量为284例),并随机分为3组。A组在经尿道切除术(TUR)后,用20mg/40ml生理盐水配制的阿霉素(ADM)进行21次膀胱内灌注,持续2年;B组给予与A组相同剂量,但在TUR前2周进行6次膀胱内灌注;C组作为对照组,仅接受TUR。A组获得了更好的预防效果。在第240天时,A组和B组计算出的总体无复发率有显著差异(P<0.05),在第480天时,A组和C组的总体无复发率也有显著差异(P<0.01)。在TUR前进行膀胱内灌注(B组)没有益处。主要的副作用是尿频和排尿疼痛,A组32%的患者出现这些副作用,B组52%的患者出现这些副作用。