狄诺塞麦与唑来膦酸对骨转移癌患者疗效和安全性比较的系统回顾和荟萃分析

骨科医师之家  2013年8月12日  阅读数:1105  字体:    

Efficacy and Safety of Denosumab Versus Zoledronic Acid in Patients With Bone Metastases: A Systematic Review and Meta-analysis

狄诺塞麦与唑来膦酸对骨转移癌患者疗效和安全性比较的系统回顾和荟萃分析

原文链接:

http://journals.lww.com/amjclinicaloncology/Abstract/2013/08000/Efficacy_and_Safety_of_Denosumab_Versus_Zoledronic.15.aspx

 

 

Background: Zoledronic acid (ZA) has been used as the standard treatment for patients with solid cancer or myeloma that has metastasized into bone. A new potential therapeutic strategy, denosumab, is being investigated in a variety of tumors. We conducted a systematic review with meta-analysis of randomized clinical trials assessing the efficacy and safety of denosumab in comparison with ZA in patients with bone metastases secondary to malignancy.

背景:目前,唑来膦酸(ZA)为治疗实体瘤或骨髓瘤(已转移至骨内部)的标准疗法。狄诺塞麦作为一种新兴的治疗药物在很多肿瘤中都有研究。我们进行了一项随机临床试验的系统回顾和荟萃分析,评价狄诺塞麦和唑来膦酸对骨转移继发恶性肿瘤患者的疗效和安全性。


Methods: A systematic literature search of several electronic databases till July 2011 and a review of reference lists of relevant articles was conducted. Summary relative estimates and 95% confidence intervals (CIs) were calculated using a fixed-effects or random-effects model, depending on the heterogeneity of the included studies.

方法:我们在几个电子数据库中对2011年7月前的文献进行了系统性检索,并回顾了相关文章的参考文献列表。根据纳入研究的异质性,运用固定效应或随机效应模型进行相对总估计,并计算95%可信区间(CIs)。


Results: Seven reports from 3 randomized controlled trials involving 5723 patients were identified. The pooled analysis showed that denosumab significantly delayed time to first on-study skeletal-related event [hazard ratio (HR)=0.83; 95% CI, 0.76-0.90, P<0.001], time to multiple skeletal-related events (HR=0.83; 95% CI, 0.76-0.90, 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 of the 2 groups were obtained with respect to overall survival (HR=0.98; 95% CI, 0.91-1.06), disease progression (HR=1.02; 95% CI, 0.96-1.09), and pain improvement. Summary of the adverse effects revealed similar safety profiles for the 2 drugs.

结果:对5723名患者进行三组随机对照试验,选取七份报告进行鉴定。汇总分析表明,相比唑来膦酸,狄诺塞麦能显著延迟骨转移癌患者首次骨相关事件[风险比(HR)=0.83; 95% CI, 0.76-0.90, P<0.001]和多个骨相关事件(HR=0.83; 95% CI, 0.76-0.90, P<0.001)的时间及其疼痛恶化程度(HR=0.92; 95% CI, 0.86-0.99, P=0.026)。两组的总存活数 (HR=0.98; 95% CI, 0.91-1.06)、疾病级数(HR=1.02; 95% CI, 0.96-1.09)以及疼痛改善结果类似。总结两种药物的副作用,发现其安全性也相似。


Conclusions: 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.

结论:对骨转移癌患者而言,狄诺塞麦在预防并发症方面优于唑来膦酸。然而,为了评价狄诺塞麦的长期疗效和安全性,仍需要对其进行进一步的研究。



责任编辑:马黎,王影影