唑来膦酸对乳腺癌患者预后影响Meta分析

Efficacy of zoledronic acid in patients with early breast cancer:systematic review and Meta-analysis

目的：系统评价唑来膦酸（zoledronic acid,ZOL）对临床早期乳腺癌（early breast cancer,EBC）患者预后的影响。方法：计算机检索Cochrane Library、PubMed、EMbase、中国生物医学文献数据库、中国期刊全文数据库、维普和万方数据库等资源,收集符合纳入标准的研究,检索时限均为从建库至2013-03,并追溯纳入研究的参考文献和手工检索相关会议资料。由2位研究者按照纳入与排除标准独立筛选文献、提取资料和评价质量后,采用RevMan 5.0软件进行Meta分析。结果：共纳入8个随机对照研究,包括7 540例患者。Meta分析结果显示,与对照组相比,ZOL可以显著提高EBC患者3年无病生存率（OR=1.67,95%CI：1.10~2.55,P=0.02）及5年总生存率（OR=1.19,95%CI：1.02~1.40,P=0.03）,显著降低5年骨转移发生率（OR=0.79,95%CI：0.63~0.98,P=0.03）;低雌激素水平亚组分析中,ZOL可显著提高5年总生存率（OR=1.39,95%CI：1.08~1.80,P=0.01）及降低复发率（OR=0.66,95%CI：0.52~0.84,P〈0.01）。结论：ZOL可能具有潜在的抗肿瘤效应,可提高临床EBC患者远期生存率,降低骨转移率,在低雌激素水平的临床EBC患者中效果更为明显,但尚需大样本高质量的RCT进一步验证。

OBJECTIVE： To assess the effectiveness of zoledronic acid in patients with early breast cancer（EBC）. METHODS： All randomized controlled trials （RCTs） on zoledronic acid for patients with EBC were retrieved from databases including Cochrane Library, PubMed, Embase, CBMdisc, CNKI, VIP and Wanfang databases. RCTs meeting inclusive criteria were included, the data were extracted, the quality was evaluated and cross-checked by two reviewers independently according to Cochrane Handbook for Systematic Reviews of Interventions,and then Meta analyses were conducted using RevMan 5.0 sotware. RESULTS： A total of eight randomized controlled trials,including 7 540 cases of patients were included. Compared with the control group, ZOL can significantly improve the 3-year disease-free survival of EBC pa tients （OR=I. 67,95%CI 1.10-2.55,P=0.02）,and 5 year overall survival rate （OR=1. 19,95%CI 1.02-1.40,P= 0.03）,significantly reduce the incidence of bone metastases in 5 years （OR 0.79,95% CI 0. 63 -0. 98 , P=0.03） ;ZOL significantly improved 5 year overall survival rate （OR=1. 39,95%CI 1.08-1.80,P=0.01） and reduce the relapse rate （ OR = 0.66,95 % CI 0.52-0.84, P〈0.01 ） in low estrogen levels subgroup. CONCLUSIONS： ZOL may have potential anti tumor effect,can improve long term survival rate,reduce the rate of bone metastases,especially in EBC patients of low levels of estrogen. This conclusion should be further proved by conducting more high quality,large scale RCTs.