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骨修饰剂作为早期乳腺癌辅助治疗的临床与经济学研究:一项系统文献综述

Clinical and economic research of bone modifiers as adjuvant therapy for early breast cancer: A systematic literature review.

作者信息

Wu Wenhua, Zhu Yixiao, Lin Huiting, Liu Jia, Liu Suyan, Zhang Lirong, Cai Jiaqin, Sun Hong, Wei Xiaoxia

机构信息

Department of Pharmacy, Fujian Provincial Hospital, Shengli Clinical Medical College of Fujian Medical University, Fuzhou University Affiliated Provincial Hospital, Fuzhou 350001, PR China; School of Pharmacy, Fujian Medical University, Fuzhou, Fujian 350001, PR China.

School of Pharmacy, Fujian Medical University, Fuzhou, Fujian 350001, PR China.

出版信息

Breast. 2025 Aug 7;83:104551. doi: 10.1016/j.breast.2025.104551.

Abstract

BACKGROUND

Adjuvant bisphosphonate therapy is recommended by some guidelines for postmenopausal breast cancer, but its application is not ideal due to inconsistent study results and economic burden considerations. This review aims to provide a comprehensive overview of bone modifiers in breast cancer adjuvant treatment to inform clinical practice and health policy.

METHODS

PubMed, Embase, Cochrane Library, and Web of Science were searched using terms related to bone modifiers and breast cancer. The included studies comprised clinical trials evaluating adjuvant bone modifiers in early breast cancer (EBC) that reported recurrence, metastasis, or survival outcomes, as well as economic studies that reported costs and effects. Quality was assessed using Cochrane Risk of Bias tool and Quality of Health Economic Studies scale. We also summarized current international guideline recommendations regarding adjuvant bone modifiers in EBC.

RESULTS

Of the 31 eligible articles, findings showed that zoledronic acid and clodronate demonstrated reduced recurrence and improved survival in low-estrogen EBC patients, whereas ibandronate showed no significant benefit. Other bisphosphonates and denosumab require further investigation. Bone modifiers were generally well-tolerated, with mild adverse events. Serious events like nephrotoxicity, osteonecrosis of the jaw, and atypical femoral fractures were rare but necessitate monitoring and prevention. Economic studies suggest that adjuvant zoledronic acid may be cost-effective for postmenopausal EBC patients.

CONCLUSION

Many unresolved issues remain regarding bone modifiers in EBC adjuvant therapy. Insufficient clinical and economic evidence precludes drawing comprehensive conclusions at present. Future studies need to provide higher-quality evidence to deepen our understanding of adjuvant therapy with bone modifiers.

摘要

背景

一些指南推荐对绝经后乳腺癌患者进行辅助双膦酸盐治疗,但由于研究结果不一致以及经济负担等因素,其应用并不理想。本综述旨在全面概述乳腺癌辅助治疗中骨修饰剂的情况,为临床实践和卫生政策提供参考。

方法

使用与骨修饰剂和乳腺癌相关的术语检索PubMed、Embase、Cochrane图书馆和Web of Science。纳入的研究包括评估早期乳腺癌(EBC)辅助骨修饰剂的临床试验,这些试验报告了复发、转移或生存结局,以及报告成本和效果的经济学研究。使用Cochrane偏倚风险工具和卫生经济研究质量量表评估质量。我们还总结了当前国际指南关于EBC辅助骨修饰剂的推荐。

结果

在31篇符合条件的文章中,研究结果显示唑来膦酸和氯膦酸盐在低雌激素EBC患者中显示出复发率降低和生存率提高,而伊班膦酸钠未显示出显著益处。其他双膦酸盐和地诺单抗需要进一步研究。骨修饰剂总体耐受性良好,不良事件轻微。肾毒性、颌骨坏死和非典型股骨骨折等严重事件虽罕见,但需要监测和预防。经济学研究表明,辅助使用唑来膦酸对绝经后EBC患者可能具有成本效益。

结论

EBC辅助治疗中骨修饰剂仍存在许多未解决的问题。目前临床和经济证据不足,无法得出全面结论。未来的研究需要提供更高质量的证据,以加深我们对骨修饰剂辅助治疗的理解。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3679/12359659/0b019bc27ed6/ga1.jpg

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