【作者】 孙蕾； 于世英；

【机构】 华中科技大学同济医学院附属同济医院肿瘤中心；

【摘要】 目的对denosumab与唑来膦酸在治疗恶性肿瘤骨转移病人的有效性及安全性进行系统评价和meta分析。方法计算机检索MEDLINE、EMbase、Cochrane图书馆(2011第4期)等数据库,手工检索相关文献的参考文献,纳入随机临床试验,并对其进行质量评价,用stata软件进行分析。结果最终纳入3个随机临床试验,包括5723个患者,meta分析结果显示:1.denosumab组首次骨相关事件发生率低于唑来膦酸组,差异有统计学意义(HR=0.83,95%CI=0.76to0.90,P<0.001);2.denosumab组再次骨相关事件发生率低于唑来膦酸组,差异有统计学意义(HR=0.83,95%CI=0.76to0.90,P<0.001);3.denosumab组疼痛恶化发生率低于唑来膦酸组,差异有统计学意义(HR=0.92,95%CI0.86-0.99,P=0.026);4.denosumab组与唑来膦酸组在病人总生存期和疾病进展方面无显著性差异;5.denosumab组与唑来膦酸组在治疗恶性肿瘤骨转移中安全性相仿。结论 denosumab在预防恶性肿瘤骨转移并发症上优于唑来膦酸,denosumab的远期疗效和安全性仍需要更多高质量多中心的随机双盲对照试验证实。更多还原

【Abstract】 Zoledronic acid (ZA) has been used as the standard treatment for patients with solid cancer or myeloma that has metastased into bone.A new potential therapeutic strategy,denosumab,is being investigated in a variety of tumors.Our aim was to conduct a systematic review with meta-analysis of randomised clinical trials assessing the efficacy and safety of denosumab in comparison with zoledronic acid (ZA) in patients with bone metastases secondary to malignancy.A systematic literature search of several electronic databases to July 2011 as well as a review of reference lists of articles was conducted.Seven reports from three randomised controlled trials (RCTs) involving 5723 patients were identified.Summary relative estimates and 95% CIs were calculated using a fixed-effects or random-effects model,depending on the heterogeneity of the included studies.The pooled analysis showed that denosumab significantly delayed time to first on-study SRE (HR = 0.83,95% CI=0.76 to 0.90,P< 0.001),time to multiple SREs (HR = 0.83,95% CI=0.76 to 0.90,P< 0.001) and pain worsening (HR = 0.92,95% CI 0.86-0.99,P=0.026) for patients with bone metastases compared with ZA.Similar results were obtained with respect to overall survival (HR = 0.98,95% CI=0.91 to 1.06),disease progression (HR = 1.02,95% CI=0.96 to 1.09) and pain improvement.Summary of the adverse effects revealed similar safety profiles for the two drugs.In conclusion,denosumab is superior to ZA in preventing complications for patients with bone metastases.However,further studies are still needed to assess longer-term safety and efficacy of denosumab.更多还原