单次腔内灌注表柔比星预防浅表性膀胱癌术后复发

Single instillation of epirubicin for the prophylaxis of recurrent primary superficial bladder carcinoma

目的 探讨临床应用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 了解表柔比星单次与多次灌注预防浅表性膀胱癌术后复发的长期疗效 ,并与丝裂霉素疗效比较。将 4 7例浅表性膀胱癌 (Ta～l,G1～ 2 )入选患者随机分为 3组 ,A组 ( 16例 )患者术后 6h内单次灌注表柔比星 80mg ;B组 ( 15例 )术后定期灌注表柔比星 4 0mg ,至术后 1年 ;C组 ( 16例 )用药为丝裂霉素 ,剂量及用法同B组。对入选病例行前瞻性、随机对照临床研究 ,随访患者无瘤生存间期、肿瘤复发率及不良反应发生情况。对所有患者术后密切随访满 3年。 结果 发现 3组患者术后 3年无病间期差异无显著性意义 (F =3 2 5 ,P >0 0 5 )。 3组膀胱癌病例中术后 1年复发情况分别为 :A组 1例( 6 2 5 % )、B组 2例 ( 13 3 % )、C组 2例 ( 12 5 % ) ,其差异无显著意义 ( χ2 =0 4 96,P >0 0 5 )。 3年复发情况分别为 :A组 5例 ( 3 3 3 % ) ,B组和C组各 4例 ( 2 6 7% ,2 5 0 % ) ,其差异亦无显著意义 ( χ2 =0 2 90 ,P >0 0 5 )。不良反应发生情况分别为 :A组 2例 ( 13 3 % )、B组 7例 ( 4 6 7% )、C组 7例( 4 3 8% ) ,A组患者不良反应发生率显著低于B、C 2组 ( χ2 =14 5 6,P <0 0 1)。

Objective To determine the feasibility of single dose intravesical epirubicin in the prevention of recurrent superficial bladder carcinoma. Methods We compared the effect of intravesical epirubicin or mitomycin C on tumor recurrence and disease free interval and their side effects after treatment of superficial bladder tumor. 47 postoperative patients with stages Ta to T1 primary superficial bladder carcinoma of grades 1or 2 were randomized into groups A: single 80 mg epirubicin; B: 40 mg consecutive epirubicin; C:40 mg consecutive mitomycin C. Patients were followed up for clinical, analytical, and cystoscopic evaluations every 3 months. Results The disease free intervals of the three groups were found no significant differences ( F =3 25, P> 0 05) The recurrence rate was 6 25%(1/16),13 3%(2/15),12 5%(2/16)(χ 2=0 496, P> 0 05) in groups A, B, and C at 1 year, and 33 3%(5/15),26 7%(4/15),25%(4/16)(χ 2=0 290, P> 0 05)at 3 years after operation, respectively Side effects of group A (13 3%) were lower than those of groups B (46 7%) or C (43 8%)(χ 2=14 56, P< 0 01) Conclusions Single dose of epirubicin given intravesically immediately after tumor resection is effective in preventing tumor recurrence