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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 systematically evaluate the effect of zoledronic acid (ZOL) on the prognosis of patients with early-stage breast cancer (EBC). METHODS: Resources such as Cochrane Library, PubMed, EMbase, Chinese Biomedical Literature Database, Chinese Journal Full-text Database, VIP and Wanfang Database were searched by computer, and the data were collected to meet the inclusion criteria. The search time ranged from database building to 2013-03 and Retrospectively incorporated references for research and manual retrieval of relevant conference materials. Two researchers independently screened the literature according to inclusion and exclusion criteria, extracted data, and evaluated the quality. Meta-analysis was performed using RevMan 5.0 software. Results: A total of 8 RCTs were included, including 7 540 patients. Meta-analysis showed that ZOL significantly increased 3-year disease-free survival (OR = 1.67, 95% CI: 1.10-2.55, P = 0.02) and 5-year overall survival (OR = 1.19 (OR = 0.79, 95% CI: 0.63-0.98, P = 0.03). In the low estrogen level subgroup analysis, ZOL (OR = 1.39, 95% CI: 1.08-1.80, P = 0.01) and reduce the recurrence rate (OR = 0.66, 95% CI: 0.52-0.84, P <0.01). Conclusion: ZOL may have potential anti-tumor effect, which can improve the long-term survival rate and reduce the bone metastasis rate in clinical EBC patients. The effect is more obvious in low estrogen clinical EBC patients, but large sample high quality RCT Further validation.