卡介苗与丝裂霉素C膀胱灌注预防浅表性膀胱癌复发疗效及毒性比较的Meta分析

目的比较卡介苗（BCG）与丝裂霉素C（MMC）膀胱灌注治疗对浅表性膀胱癌复发的预防作用及治疗毒性等方面的特点。方法收集国内外关于BCG与MMC膀胱灌注治疗浅表性膀胱癌的比较性研究文献，对结果进行统计学综合分析（Meta分析）。采用优势比（OR）及其95％可信区间（95％CI）作为评价比较疗效及毒性差异的指标。统计学分析采用RevMan4．2软件。结果共收集国内外17个临床研究，包括1600例进行BCG、1503例进行MMC膀胱灌注治疗的患者被纳入分析。最大随访期内，BCG治疗组与MMC治疗组分别有599例（37．4％）、684例（45．5％）复发。Meta分析显示，BCG与MMC膀胱灌注治疗预防肿瘤复发的疗效差异有统计学意义，BCG显著优于MMC（OR0．58，95％CI 0．42～0．80，P=0．0009）。8个较详细报道治疗副作用的比较研究中，Meta分析显示膀胱炎发生率BCG组显著高于MMC组（OR1．97，95％CI 1．31～2．98，P=0．001）。结论BCG膀胱灌注预防浅表性膀胱癌复发作用优于MMC，可以显著减少肿瘤复发，但膀胱炎发生率明显高于MMC。

Comparison of intravesical bacillus Calmette-Guerin versus mitomycin C for the prevention of recurrence of superficial bladder cancer and their toxicity: meta-analysis

Objective To compare the prophylactic efficacy and treatment toxicity of intravesical bacillus Calmette-Guerin(BCG) versus mitomycin C(MMC) in recurrence of superficial bladder cancer by pooling the data of included controlled studies.Methods We retrieved published comparative studies on intravesical BCG versus MMC for superficial bladder cancer,and pooled the data from eligible studies(meta-analysis).Odds ratio(OR) and its 95% confidence interval(CI) were used as the measurement parameter of efficacy and toxicity comparison.The statistical analyses were performed using RevMan4.2 software.Results A total of 17 trials were eligible for the inclusion criteria,including 1600 patients treated with BCG and 1503 with MMC.With regard to the prophylactic efficacy,within the maximum follow-ups,599 patients treated with BCG(37.4%) and 684 with MMC(45.5%) had recurrence of bladder tumor.Pooling results of meta-analysis indicated that BCG was statistically significantly superior to MMC in the prevention of tumor recurrence(OR,0.58;95%CI,0.42-0.80;P=0.0009).With regard to the treatment toxicity,pooling data of 8 studies which reported comparative data on toxicity showed significantly higher incidence of cystitis in BCG group compared with MMC group(OR,1.97;95%CI,1.31-2.98;P=0.001).Conclusions The results of this meta-analysis suggest that intravesical BCG is superior to MMC in the prevention of tumor recurrence,it may significantly reduce the recurrence of superficial bladder cancer.However,the cystitis incidence of BCG therapy is significantly higher than that of MMC therapy.