表柔比星与丝裂霉素膀胱内单次与多次灌注预防浅表性膀胱癌术后复发

Single or consecutive instillation of epirubicin or mitomycin C for the prophylaxis of recurrent primary superficial bladder carcinoma

目的 :研究表柔比星单次与多次灌注预防浅表性膀胱癌术后复发的有效性 ,比较与丝裂霉素疗效的差异 ,探讨表柔比星单次腔内灌注预防浅表性膀胱癌术后复发的可行性。方法 :对多中心入选病例行前瞻性、随机对照临床研究 ,随访患者肿瘤复发及不良反应发生情况。结果 :表柔比星单次灌注组 (A组 ,80mg/次 )、多次灌注组(B组 ,40mg/次 )及丝裂霉素多次灌注组 (C组 ,40mg/次 )病例术后 1年复发率分别为 2 2 2 % (8/ 36 )、18 2 % (6 /33)、2 1 9% (7/ 32 ) (χ2 检验 ,P >0 0 5 ) ;不良反应发生率分别为 2 5 % (9/ 36 )、42 4% (14/ 33)、43 8% (14/ 32 ) ,表柔比星单次灌注组患者不良反应发生率显著低于B、C两组者 (χ2 检验 ,P <0 0 1)。 3组患者随访 1年的无病间期经F检验无统计学差异。结论 :表柔比星膀胱灌注预防浅表性膀胱癌术后复发的作用可靠 ,单次灌注法经济、方便、不良反应发生率低 。

Purpose:The aims of the present study were to compare the efficacy in the prevention of tumor recurrence, disease free interval and side effects of intravesical epirubicin or mitomycin C postoperatively in superficial bladder tumor, and to determine the feasibility of single dose intravesical epirubicin. Methods:A total of 103 postoperative patients with stages Ta to T1 primary superficial,grades 1 or 2 bladder carcinoma was randomized into study groups A single 80 mg dose of epirubicin, B 40 mg epirubicin consecutively, C 40 mg mitomycin consecutively. Patients were followed for clinical, analytical ,and cystoscopic evaluations every 3 months. Results:The recurrence rates were 22.2% (8/36)、18.2% (6/33)、21.9% (7/32) of group A,B and C at 1 year after operation,respectively (χ 2, P >0.05). Side effects of A group(25%) were lower than that of B (42.4%) or C group (43.8%) χ 2, P <0 01). The disease free intervals of the three groups were found to have no significant differences (F, P >0 05). Conclusions:A single 80 mg dose of epirubicin given intravesically immediately after tumor resection is safe,economic,well tolerated, and effective in the prevention of tumor recurrence. The long term effect of this treatment remains to be studied.