丝裂霉素与卡介苗膀胱灌注预防浅表性膀胱癌有效性和安全性的系统评价

Efficacy and Safety of Intravesical Mitomycin C versus Bacillus Calmette-Guerin for Superficial Bladder Cancer: A Systematic Review

目的:系统评价丝裂霉素与卡介苗膀胱灌注预防浅表性膀胱癌的有效性和安全性。方法:计算机检索Pub Med、MEDLINE(Ovid)、EMBASE、Cochrane Library、CNKI、维普、万方等数据库,查找丝裂霉素(MMC)与卡介苗(BCG)单独膀胱灌注预防浅表性膀胱癌的随机对照试验(RCT),检索时限均从建库至2013年6月31日。由2名研究者按照纳入、排除标准独立筛选文献、提取资料和质量评价后,采用Rev Man5.2软件进行Meta分析。结果:纳入12个RCT,共2 602例患者。Meta分析结果显示,应用MMC单独膀胱灌注预防浅表性膀胱癌(MMC组)的首次复发率、3年复发率、疾病进展、死亡率与应用BCG(BCG组)比较,差异无统计学意义([RR=0.99,95%CI(0.85,1.14),P=0.86];[RR=0.89,95%CI(0.71,1.13),P=0.35];[RR=0.85,95%CI(0.64,1.13),P=0.27];[RR=1.12,95%CI(0.76,1.64),P=0.57])。在药物不良反应方面,MMC组血尿、发热、排尿困难的发生率显著低于BCG组([RR=0.34,95%CI(0.16,0.71),P=0.004];[RR=0.14,95%CI(0.06,0.32),P<0.000 01];[RR=0.71,95%CI(0.58,0.86),P=0.000 6])。结论:膀胱灌注预防浅表性膀胱癌MMC的首次复发率、3年复发率、疾病进展、死亡率与BCG相似,安全性优于BCG。

OBJECTIVE：To evaluate the efficacy and safety of intravesical mitomycin C （MMC） versus Bacillus Calmette-Guerin （BCG） for superficial bladder cancer. METHODS： The literature about randomized controlled trials （RCTs） on intravesical MMC versus BCG for superficial bladder cancer were retrieved from databases such as PubMed, EMbase, CBM, the Cochrane Library, CNKI, VIP and WanFang Data （from the date of their establishment to June 30, 2013）. According to the inclusion and exclusion criteria, two reviewers independently screened the literature, extracted data and assessed the quality of the included studies. Meta-analysis was conducted using RevMan 5.2 software. RESULTS： A total of 12 RCTs involving 2 602 patients were included. The results of meta-analysis showed that there were no statistically significant differences regarding the first time recurrence rate, 3-years recurrence rate, disease progression, and mortality between MMC group and BCG group [RR =0.99, 95% CI （0.85, 1.14）, P =0. 86;RR =0. 89, 95%CI （0.71, 1.13）, P =0. 35; RR =0. 85, 95%CI （0.64, 1.13）, P =0. 27; RR=I. 12,95% CI （0. 76, 1.64） , P = 0. 57 ]. The incidences of hematuria, fever, dysuria in MMC group was lower than in the BCG group [RR =0.34,95% CI （0.16, 0.71）, P =0.004; RR =0.14, 95% CI （0.06, 0.32）, P 〈 0.00001; RR =0. 71,95%CI （0.58, 0. 86） , P =0. 0006]. CONCLUSION： The first time recurrence rate, 3-year recurrence rate, disease progression and mortality were similar between MMC group and BCG group, but MMC is safer than BCG.