卡介苗联合化疗药物交替膀胱灌注预防表浅性膀胱癌TURB-t术后复发的系统评价

Sequential Bacillus Calmette-guerin plus Chemotherapy for Prevention of Post-operative Recurrence of Superficial Bladder Cancer:A Systematic Review

目的系统评价卡介苗联合化疗药物交替膀胱灌注与单用卡介苗膀胱灌注预防表浅性膀胱癌TURB-t术后复发的临床疗效和不良反应。方法电子检索PubMed(1950～2006.12)﹑OVID(1966～2006.12)﹑EMbase(1984～2006.12)﹑Cochrane图书馆(2006年第4期)、中国生物医学文献数据库(1978～2006)和维普中文科技期刊数据库(1989～2006),并手工检索已发表和未发表文献,纳入卡介苗联合化疗药物交替膀胱灌注预防表浅性膀胱癌TURB-t术后复发的随机对照试验,按Cochrane系统评价方法对纳入研究进行质量评价,并采用RevMan4.2.9软件进行Meta分析。结果共纳入4个随机对照试验,包括681例表浅性膀胱癌患者。Meta分析结果显示,卡介苗联合化疗药物交替膀胱灌注与单用卡介苗膀胱灌注相比,①对于Ta和T1期表浅性膀胱癌,复发率差异有统计学意义[RR合并0.69,95%CI(0.53,0.90)];②对于Tis期表浅性膀胱癌,复发率差异无统计学意义[RR1.22,95%CI(0.97,1.54)];③不良反应发生率差异无统计学意义[RR合并0.85,95%CI(0.70,1.03)]。结论卡介苗联合化疗药物交替膀胱灌注与单用卡介苗膀胱灌注相比,对于Ta和T1期表浅性膀胱癌,前者能有效降低TURB-t术后肿瘤复发率;对于Tis期膀胱癌,两者在TURB-t术后肿瘤复发率差异无统计学意义;在副作用发生率方面,两者差异也无统计学意义。但由于本系统评价纳入研究数量少,且存在选择偏倚、实施偏倚以及发表偏倚的中度可能性,很可能影响结果的可靠性,故应谨慎看待以上结论,期待更多高质量的随机对照试验提供更可靠的证据。

Objective To assess the clinical efficacy and treatment-induced side effects of intravesically administered bacillus calmette-guerin （BCG） plus chemotherapy following TURB-t in patients with superficial bladder cancer compared withBCG alone. Methods Randomized controlled trials （RCTs） were identified from PubMed （1950 to December 2006）, Ovid （1966 to December 2006）, EMbase （1984 to December 2006）, The Cochrane Library （Issue 4, 2006）, CBM （1978 to 2006） and VIP（1989 to 2006）. We also handsearched relevant published and unpublished reports as well as their references. The quality of included trials was evaluated by two reviewers. We used The Cochrane Collaboration＇s RevMan 4.2.9 software for statistical analysis. Results Four studies involving 681 patients were included. Meta-analyses showed that, in patients withTa and T1 bladder cancer,there was a significant difference in the recurrence rate between intravesically administered BCG plus chemotherapy and BCG alone （RR 0.69, 95%CI 0.53 to 0.90）. In patients with Tis bladder cancer, no significant difference was found in the recurrence rate between the two groups （RR 1.22, 95%CI 0.97 to 1.54）. In patients withTa, T1 and Tis bladder cancer,no statistically significant difference was found in the incidence of side effects （RR 0.85, 95%CI 0.70 to 1.03）. Conclusion Compared with BCG alone, intravesically administered BCG plus chemotherapy in patients with Ta and T1 superficial bladder cancer can reduce the incidence of tumor recurrence more effectively. For patients withTis bladder cancer the two therapeutic regimens do not differ in the incidence of tumor recurrence. The two regimens have similar side effects. There is a moderate possibility of selection bias,performance bias and publication bias in the small number of included studies,which weakens the strength of the evidence of our results. Better evidence from more high-quality double-blind randomized controlled trials is needed.