期刊文献+

地舒单抗与唑来膦酸在实体肿瘤骨转移和多发性骨髓瘤患者中应用效果和安全性的Meta分析 被引量:2

Efficacy and safety of denosemab versus zoledronic acid in patients with solid tumors bone metastases and multiple myeloma:a meta-analysis
下载PDF
导出
摘要 目的 系统评价地舒单抗与唑来膦酸在实体肿瘤骨转移和多发性骨髓瘤患者中的应用效果和安全性。方法 计算机检索PubMed、Embase、Cochrane Library、Web of Science、CNKI、WanFang Data和VIP数据库,搜集地舒单抗与唑来膦酸在实体肿瘤骨转移和多发性骨髓瘤患者中应用的随机对照试验(RCT),检索时限均为建库至2023年11月21日。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.3软件进行Meta分析。结果 共纳入5个RCT,包括8 957例患者。Meta分析结果显示,地舒单抗在推迟发生首次骨相关事件的时间[HR=0.85,95%CI(0.80,0.92),P<0.001]和发生首次及后续骨相关事件的时间[HR=0.87,95%CI(0.79,0.96),P=0.004]方面优于唑来膦酸。地舒单抗组肾脏毒性[RR=0.70,95%CI(0.58,0.85),P <0.001]、急性期反应[RR=0.46,95%CI(0.40,0.51),P <0.001]、贫血[HR=0.91,95%CI(0.85,0.98),P=0.008]和食欲下降/厌食[RR=0.89,95%CI(0.81,0.98),P=0.02]的发生率低于唑来膦酸组,但低钙血症的发生率更高[RR=1.72,95%CI(1.49,1.99),P <0.001]。两组在总生存期、疾病进展时间、不良事件发生率和严重不良事件发生率方面差异均无统计学意义(P> 0.05)。结论 当前证据表明,与唑来膦酸相比,地舒单抗能显著延迟实体瘤骨转移和多发性骨髓瘤引起骨相关事件的时间;在安全性方面,地舒单抗导致肾毒性、急性期反应、贫血和食欲下降/厌食的风险较低,但导致低钙血症的风险较高。 Objective To systematically review the efficacy and safety of denosemab and zoledronic acid in patients with solid tumors bone metastases and multiple myeloma.Methods Pubmed,Embase,Cochrane Library,Web of Science,CNKI,WanFang Data and VIP databases were electronically searched for randomized controlled trials(RCTs)related to denosemab and zoledronic acid in the solid tumors bone metastases and multiple myeloma from inception to November 21,2023.Two reviewers independently screened literature,extracted data and assessed the risk of bias of included studies,and Meta-analysis was performed by using RevMan 5.3 software.Results A total of 5 RCTs,involving 8957 patients were included.The results of Meta-analysis showed that denosumab was effective in delaying the time to first bone-related event(SRE)(HR=0.85,95%CI 0.80 to 0.92,P<0.001)and the time to first and subsequent SRE time(HR=0.87,95%CI 0.79 to 0.96,P=0.004)were superior to zoledronic acid.Denosumab had lower incidence of nephrotoxicity(RR=0.70,95%CI 0.58 to 0.85,P<0.001),acute phase response(RR=0.46,95%CI 0.40 to 0.51,P<0.001),anemia(RR=0.91,95%CI 0.85 to 0.98,P=0.008)and appetite decreased/anorexia(RR=0.89,95%CI 0.81 to 0.98,P=0.02),but the incidence of hypocalcemia was higher(RR=1.72,95%CI 1.49 to 1.99,P<0.001).There were no significant differences between denosumab and zoledronic acid in terms of overall survival,time to disease progression,incidence of adverse events and serious adverse events(P>0.05).Conclusion Current evidence shows that compared with zoledronic acid,denosemab can significantly delay SREs induced by solid tumors bone metastases and multiple myeloma.In terms of safety,the risk of denosemab-induced nephrotoxicity,acute phase reactions,anemia and decreased appetite/anorexia are lower,but the risk of denosemab-induced hypocalcemia is higher.
作者 甄路路 刘学峁 陈建琦 杨海 ZHEN Lulu;LIU Xuemao;CHEN Jianqi;YANG Hai(Department of Pharmacy,Qingdao Central Hospital,University of Health and Rehabilitation Sciences,Qingdao 266042,Shandong Province,China;School of Medicine,Ocean University of China,Qingdao 266003,Shandong Province,China)
出处 《药物流行病学杂志》 CAS 2024年第2期194-202,共9页 Chinese Journal of Pharmacoepidemiology
基金 山东省药品临床综合评价项目(2021YZ014)。
关键词 地舒单抗 唑来膦酸 骨转移 实体肿瘤 多发性骨髓瘤 骨相关事件 META分析 随机对照试验 Denosemab Zoledronic acid Bone metastasis Solid tumors Multiple myeloma Bone-related events Meta-analysis Randomized controlled trial
  • 相关文献

参考文献5

二级参考文献32

  • 1Hughes DE, Wright KR, Uy HL, et al. Bisphosphonates promote apoptosis in murine osteoclasts in vitro and in vivo. J Bone Miner Res, 1995, 10:1478-1487.
  • 2Rogers MJ, Chilton KM, Coxon FP, et al. Bisphosphonates induce apoptosis in mouse maerophage-like ceils in vitro by a nitric oxideindependent mechanism. J Bone Miner Res, 1996, 11: 1482-1491.
  • 3Rosen LS, Cordon D, Kaminski M, et al. Long-term efficacy and safety of zoledronic acid compared with pamidronate disadium in the treatment of skeletal complications in patients with advanced multiple myeloma or breast carcinoma: a randomized, double-blind, multicenter, comparative trial. Cancer, 2003, 98 : 1735-1744.
  • 4Rosen LS, Gordon D, Tchekmedyian S, et al. Zoledronie acid versus placebo in the treatment of skeletal metastases in patients with lung cancer and other solid tumors: a phase Ⅲ, double-blind, randomized triM. J Clin Oncol, 2003, 21:3150-3157.
  • 5Saad F, Gleason DM, Murray R, et al. A randomized, placebocontrolled trial of zoledronic acid in patients with hormonerefractory metastatic prostate carcinoma. J Natl Cancer Inst, 2002, 94 : 1458-1468.
  • 6Kohno N, Aogi K, Minami H, et al. Zoledronic acid significantly reduces skeletal complications compared with placebo in Japanese women with bone metastases from breast cancer: a randomized, placebo-controlled trial. J Clin Oncol, 2005, 23:3314-3321.
  • 7Demers LM, Costa L, Lipton A. Biochemical markers and skeletal metastases. Cancer, 2000, 88:2919-2926.
  • 8Lipton A, Costa L, Ali SM, et al. Bone markers in the management of metastatic bone disease. Cancer Treat Rev, 2001, 27 : 181-185.
  • 9Brown JE, Thomson CS, Ellis SP, et al. Bone resorption predicts for skeletal complications in metastatic bone disease. Br J Cancer, 2003, 89:2031-2037.
  • 10Brown JE, Cook R J, Major P, et al. Bone turnover markers as predictors of skeletal complications in prostate cancer, lung cancer, and other solid tumors. J Natl Cancer Inst, 2005, 97:59-69.

共引文献36

同被引文献13

引证文献2

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部