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每月米诺膦酸盐治疗接受芳香化酶抑制剂的绝经后乳腺癌患者的疗效和安全性。

Efficacy and Safety of Monthly Minodronate Therapy in Postmenopausal Breast Cancer Patients Receiving Aromatase Inhibitors.

机构信息

Department of Surgery, Faculty of Medicine, Kurume University, Fukuoka, Japan;

Department of Surgery, Faculty of Medicine, National Defense Medical College, Saitama, Japan.

出版信息

Anticancer Res. 2022 Aug;42(8):4139-4143. doi: 10.21873/anticanres.15912.

Abstract

BACKGROUND/AIM: Post-menopausal breast cancer (BC) patients who receive adjuvant aromatase inhibitor (AI) therapy may be at increased risk of bone loss, osteoporosis, and bone fracture. We aimed to evaluate the efficacy and safety of oral bisphosphonate minodronate in preventing bone loss complications.

PATIENTS AND METHODS

Patients receiving AI and 80% of those with suboptimal bone mineral density (BMD) were prescribed monthly oral minodronate 50 mg every 4 weeks for 72 weeks. BMD, bone metabolism markers, incidence of bone fractures, medication compliance, and other adverse events (AE) were examined every 24 weeks following administration.

RESULTS

Fifty postmenopausal BC patients with a median age of 64.0 years were enrolled. The mean value of lumbar spine BMD was higher than that of the value before the minodronate administration at each observation point. Before and after the treatment, the median serum values of Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) (mU/dl) and serum type I collagen cross-linked N-telopeptide (NTX) (nmolBCE/l) were decreased from 535.7 and 18.5 to 230.1 and 11.9, respectively. No adverse grade 2 or higher event was observed throughout this study.

CONCLUSION

The combined administration of minodronate and AIs was safe and effective in preventing bone loss complications in postmenopausal BC patients.

摘要

背景/目的:接受辅助芳香酶抑制剂(AI)治疗的绝经后乳腺癌(BC)患者可能面临更高的骨质流失、骨质疏松症和骨折风险。我们旨在评估口服双膦酸盐米诺膦酸预防骨质流失并发症的疗效和安全性。

患者和方法

接受 AI 治疗且 80%患者的骨矿物质密度(BMD)不理想的患者,每月口服米诺膦酸 50mg,每 4 周一次,共 72 周。在给药后每 24 周检查 BMD、骨代谢标志物、骨折发生率、药物依从性和其他不良事件(AE)。

结果

50 名绝经后 BC 患者,中位年龄 64.0 岁,纳入研究。腰椎 BMD 的平均值在每个观察点均高于米诺膦酸治疗前的值。治疗前后,血清抗酒石酸酸性磷酸酶 5b(TRACP-5b)(mU/dl)和血清 I 型胶原交联 N 端肽(NTX)(nmolBCE/l)中位数分别从 535.7 和 18.5 降至 230.1 和 11.9。整个研究过程中未观察到任何不良的 2 级或更高等级事件。

结论

米诺膦酸联合 AI 治疗可安全有效地预防绝经后 BC 患者的骨质流失并发症。

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