地诺单抗治疗前列腺癌骨转移安全性和有效性的系统评价与meta分析  

Efficacy and safety of denosumab in the treatment of prostate cancer with bone metastases:A systematic review and meta-analysis

作　　者：杨丽 房波 何灿琴 詹绪新 肖友平 秦小君 娄强 商学军 YANG Li;FANG Bo;HE Can-qin;ZHAN Xu-xin;XIAO You-ping;QIN Xiao-jun;LOU Qiang;SHANG Xue-jun(Department of Orthopaedics,The Second Affiliated Hospital of Guizhou University of Chinese Medicine,Guiyang,Guizhou 550001,China;Department of Urology,Jinling Hospital,Affiliated Hospital of Medical School,Nanjing University,Nanjing,Jiangsu 210002,China;Department of Urology,General Hospital of Eastern Theater Command,Nanjing,Jiangsu 210002,China;Department of Reproductive Medicine,Xi'an Peoples'Hospital/Xi'an Fourth Hospital,Xi'an,Shaanxi 710004,China)

机构地区：[1]贵州中医药大学第二附属医院脊柱骨科,贵州贵阳550001 [2]南京大学医学院附属金陵医院泌尿外科,江苏南京210002 [3]东部战区总医院泌尿外科,江苏南京210002 [4]西安市人民医院/西安市第四医院生殖医学中心,陕西西安710004

出　　处：《中华男科学杂志》2025年第4期349-356,共8页National Journal of Andrology

基　　金：贵州省卫生健康委员会科学技术基金(gzwjkj2019-1-212)。

摘　　要：目的:系统评价地诺单抗在治疗前列腺癌骨转移中的有效性和安全性。方法:检索PubMed、EMBASE、Cochrane、Web of Science、中国生物医学文献数据库、中国知网、万方医学数据库,纳入相关文献。采用Cochrane风险偏倚评估工具对纳入文献质量进行评价,并提取有效数据。使用Revman 5.4和RStudio软件进行meta分析,并绘制森林图。结果:meta分析共纳入6项随机对照试验。结果显示,与对照组相比,地诺单抗明显降低了骨相关事件的风险(HR=0.78,95%CI 0.62~0.93)。在安全性方面,与对照组相比,并未增加总不良事件、严重不良事件及通用毒性标准3级或更高级别不良事件的风险。结论:地诺单抗能够延长首次骨相关事件发生的时间,并在安全性方面表现良好。然而,由于本研究的局限性,仍需开展高质量、大样本、多中心的随机对照试验以进一步验证本研究结果。Objective:To evaluate the efficacy and safety of denosumab in the treatment of prostate cancer with bone metastases.Methods:Relevant studies were retrieved from PubMed,EMBASE,Cochrane,Web of Science,Sinomed,CNKI and Wanfang databases.The Cochrane risk-of-bias assessment tool was used to evaluate the quality of included studies,and relevant data were extracted.meta-analysis was performed using RevMan 5.4 and RStudio software,and forest plots were generated.Results:Six randomized controlled trials(RCTs)were included.Compared with the control group,denosumab significantly reduced the risk of skeletal-related events(HR=0.78,95%CI:0.62–0.93).In terms of safety,denosumab did not increase the risk of total adverse events,severe adverse events and the adverse events higher than CTC grade 3.Conclusion:Denosumab can delay the time to first skeletal-related event with good safety.However,due to the limitations of this study,further high-quality,large-sample,multicenter RCTs are needed to confirm these findings.

关 键 词：地诺单抗 前列腺癌骨转移 META分析 系统综述 随机对照试验 

分 类 号：R737.25[医药卫生—肿瘤]