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阿巴洛肽、地诺单抗、特立帕肽、口服双膦酸盐和静脉注射双膦酸盐治疗男性骨质疏松症的疗效和安全性:一项系统评价和贝叶斯网络荟萃分析

Efficacy and safety of abaloparatide, denosumab, teriparatide, oral bisphosphonates, and intravenous bisphosphonates in the treatment of male osteoporosis: a systematic review and Bayesian network meta-analysis.

作者信息

Chen Liangshi, Ji Bomei, Xia Cong

机构信息

Orthopedics, The First People's Hospital of Taicang, Taicang Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China.

Anesthesiology and Surgery, The First People's Hospital of Taicang, Taicang Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China.

出版信息

Front Endocrinol (Lausanne). 2025 Apr 16;16:1558560. doi: 10.3389/fendo.2025.1558560. eCollection 2025.

DOI:10.3389/fendo.2025.1558560
PMID:40309441
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12040664/
Abstract

STUDY DESIGN

A Systematic Review and Bayesian Network Meta-Analysis.

OBJECTIVE

To compare the efficacy and safety of abaloparatide (ABA), denosumab (DEN), teriparatide (TER), oral bisphosphonates (OBP), and intravenous bisphosphonates (IBP) in the treatment of male osteoporosis through a network meta-analysis.

SUMMARY OF BACKGROUND DATA

Currently, a variety of medications are available for the treatment of male osteoporosis, including abaloparatide, denosumab, teriparatide, and bisphosphonates. These medications are widely applied in male osteoporosis, and existing randomized controlled trials (RCTs) provide strong evidence of their efficacy. However, there is a lack of sufficient systematic comparative studies to guide the choice between these treatments, particularly for specific male osteoporosis populations.

METHODS

This systematic review and network meta-analysis (NMA) were conducted strictly in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and the relevant standards recommended by the Cochrane Collaboration. We performed pairwise meta-analysis using Stata 18.0 software to assess the magnitude of effect sizes and the consistency of findings across studies. For network meta-analysis (NMA), we used R version 4.3.1 along with the gemtc and BUGSnet packages to handle complex multi-treatment comparisons. Using these methods, we were able to comprehensively assess the relative efficacy and safety of different treatment options. All statistical analyses were conducted using Review Manager software (version 5.4), a widely used tool in medical research for meta-analysis, forest plot generation, and bias risk assessment.

RESULTS

Overall, clinical decisions should carefully balance drug efficacy and safety. Although TER performs best in reducing the occurrence of all adverse events, its efficacy in some BMD targets (such as total hip BMD) is relatively lower. In comparison, while OBP has a clear advantage in reducing severe adverse events, its efficacy in some BMD improvements (such as femoral neck BMD) is slightly less. Therefore, clinicians should consider the specific needs of the patient, the treatment goals, and the safety profile of the drug when selecting a medication, particularly for long-term use.

CONCLUSION

The results indicate that abaloparatide and teriparatide are significantly superior to other drugs in improving lumbar spine and femoral neck BMD, while oral bisphosphonates is the most effective in improving total hip BMD. In terms of safety, teriparatide demonstrates the best performance in all adverse events, and oral bisphosphonates shows a clear advantage in reducing severe adverse events. Future treatment decisions should balance efficacy and safety, with clinical treatment tailored to the individual needs of the patient, including the site of bone loss and sensitivity to adverse events. Future research should explore combination therapies or multi-target strategies to optimize both efficacy and safety.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccee/12040664/5dcb5d59a16e/fendo-16-1558560-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccee/12040664/fa5b05001676/fendo-16-1558560-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccee/12040664/a74b39010c5f/fendo-16-1558560-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccee/12040664/5e894c0dc92a/fendo-16-1558560-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccee/12040664/3bea9fad2a15/fendo-16-1558560-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccee/12040664/06246021864b/fendo-16-1558560-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccee/12040664/565ca681886b/fendo-16-1558560-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccee/12040664/56e44e7b393a/fendo-16-1558560-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccee/12040664/5dcb5d59a16e/fendo-16-1558560-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccee/12040664/fa5b05001676/fendo-16-1558560-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccee/12040664/a74b39010c5f/fendo-16-1558560-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccee/12040664/5e894c0dc92a/fendo-16-1558560-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccee/12040664/3bea9fad2a15/fendo-16-1558560-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccee/12040664/06246021864b/fendo-16-1558560-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccee/12040664/565ca681886b/fendo-16-1558560-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccee/12040664/56e44e7b393a/fendo-16-1558560-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccee/12040664/5dcb5d59a16e/fendo-16-1558560-g008.jpg
摘要

研究设计

系统评价与贝叶斯网络荟萃分析。

目的

通过网络荟萃分析比较阿巴洛肽(ABA)、地诺单抗(DEN)、特立帕肽(TER)、口服双膦酸盐(OBP)和静脉注射双膦酸盐(IBP)治疗男性骨质疏松症的疗效和安全性。

背景数据总结

目前,有多种药物可用于治疗男性骨质疏松症,包括阿巴洛肽、地诺单抗、特立帕肽和双膦酸盐。这些药物在男性骨质疏松症中广泛应用,现有的随机对照试验(RCT)为其疗效提供了有力证据。然而,缺乏足够的系统比较研究来指导这些治疗方法之间的选择,特别是针对特定的男性骨质疏松症人群。

方法

本系统评价和网络荟萃分析(NMA)严格按照PRISMA(系统评价和荟萃分析的首选报告项目)指南以及Cochrane协作网推荐的相关标准进行。我们使用Stata 18.0软件进行成对荟萃分析,以评估效应量的大小和各研究结果的一致性。对于网络荟萃分析(NMA),我们使用R版本4.3.1以及gemtc和BUGSnet软件包来处理复杂的多治疗比较。使用这些方法,我们能够全面评估不同治疗方案的相对疗效和安全性。所有统计分析均使用Review Manager软件(版本5.4)进行,该软件是医学研究中广泛用于荟萃分析、森林图生成和偏倚风险评估的工具。

结果

总体而言,临床决策应仔细权衡药物疗效和安全性。虽然特立帕肽在降低所有不良事件的发生率方面表现最佳,但其在某些骨密度指标(如全髋骨密度)上的疗效相对较低。相比之下,口服双膦酸盐在降低严重不良事件方面具有明显优势,但其在某些骨密度改善(如股骨颈骨密度)方面的疗效略低。因此,临床医生在选择药物时,特别是长期使用时,应考虑患者的具体需求、治疗目标和药物的安全性。

结论

结果表明,阿巴洛肽和特立帕肽在改善腰椎和股骨颈骨密度方面显著优于其他药物,而口服双膦酸盐在改善全髋骨密度方面最有效。在安全性方面,特立帕肽在所有不良事件中表现最佳,口服双膦酸盐在降低严重不良事件方面具有明显优势。未来的治疗决策应平衡疗效和安全性,根据患者的个体需求进行临床治疗,包括骨质流失部位和对不良事件的敏感性。未来的研究应探索联合治疗或多靶点策略,以优化疗效和安全性。

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