表在性膀胱腫瘍に対するピラルビシン(THP)の膀胱内注入時間の違いによる再発予防効果に関する検討

Abstract

表在性膀胱腫瘍に対する術後の再発予防効果と副作用発現率を調べる目的で, 2時間注入群, 5分間注入群, 対照群の3群に分けてTHPの膀胱内注入療法のrandomized studyを行った.対照群と比較して, 再発予防効果は2時間注入群において認められ, 副作用発現率には2時間注入群と5分間注入群で有意差を認めなかったことから, このような注入条件においては, 2時間注入群が優れている

In order to determine the modality of prophylactic intravesical instillation of pirarubicin (THP = tetrahydropyranyladriamycin) following transurethral resection (TUR) of superficial bladder cancer, a prospective randomized study was performed. A total of 79 patients were randomized into "2-hour instillation" (A), "5-min instillation" (B) and "control" (C) groups. Prophylactic efficacy and side effects were analyzed in each group. In groups A and B, 20 mg of THP was first dissolved in 10 ml of distilled water, adjusted to 40 ml with saline and was administered intravesically once a week for 10 weeks, starting from 1 week after TUR. The recurrence-free rate was calculated in 65 evaluable patients. The one-year recurrence-free rate was 70.2% in group A, 62.8% in group B and 52.1% in group C. The one-year recurrence-free rate was significantly higher in group A than in group C. Adverse effects were observed in 21.4% of the patients in group A and 40.7% in group B. There was no significant difference in the occurrence rate of side effects between these two groups. Taking the prophylactic efficacy and side effects into consideration, "2-hour instillation" seemed to be better than "5-min instillation".