Department of Medical Oncology, General Hospital of The Yangtze River Shipping, Wuhan, China.
Oncol Res Treat. 2016;39(7-8):453-9. doi: 10.1159/000447372. Epub 2016 Jun 29.
Bone metastases lead to local bone destruction and skeletal complications. Bisphosphonates, particlulaly zoledronic acid (ZA), play a central role in the treatment of bone metastases. Some studies have shown that denosumab may delay and prevent SREs in metastatic bone disease more effectively than ZA; therefore, we systematically reviewed and assessed the safety of denosumab and ZA.
The PubMed, EMBASE, Cochrane Library, Web of Science with Conference Proceedings, Elsevier, and China National Knowledge Infrastructure (CNKI) databases were searched up to October 2015. 2 independent reviewers extracted data from each eligible study using a standard protocol, and both fixed-effects and random-effects models were used to analyze and evaluate the data extracted from eligible articles.
6 randomized controlled trials enrolling 13,733 patients were included. Occurrences of adverse events were generally similar between the denosumab and ZA groups except anemia and anorexia in patients with bone metastases and back pain and bone pain. However, occurrences of serious adverse events such as hypocalcaemia , renal adverse events , and new primary malignancy were significantly different between the denosumab and ZA groups. Only the occurrence of osteonecrosis of the jaw showed no significant difference between the denosumab and ZA groups in patients with bone metastases.
Denosumab was safer in delaying or preventing skeletal-related events in patients with bone metastases and prevented pain progression compared to ZA in this meta-analysis.
骨转移可导致局部骨质破坏和骨骼并发症。双膦酸盐，特别是唑来膦酸（ZA），在治疗骨转移中发挥着核心作用。一些研究表明，地舒单抗在预防和延缓转移性骨疾病的骨骼相关事件（SREs）方面可能比 ZA 更有效；因此，我们系统地回顾和评估了地舒单抗和 ZA 的安全性。
检索了截至 2015 年 10 月的 PubMed、EMBASE、Cochrane 图书馆、Web of Science with Conference Proceedings、Elsevier 和中国国家知识基础设施（CNKI）数据库。2 位独立评审员使用标准方案从每个合格研究中提取数据，并使用固定效应和随机效应模型分析和评估从合格文章中提取的数据。
纳入了 6 项随机对照试验，共 13733 名患者。除了转移性骨病患者的贫血和厌食症以及背痛和骨痛外，地舒单抗和 ZA 组的不良事件发生率通常相似。然而，低钙血症、肾脏不良事件和新发原发性恶性肿瘤等严重不良事件的发生率在地舒单抗和 ZA 组之间存在显著差异。只有在转移性骨病患者中，地舒单抗和 ZA 组的颌骨坏死发生率无显著差异。
在预防和延缓骨骼相关事件方面，地舒单抗比 ZA 更安全，在预防疼痛进展方面也优于 ZA。
