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绝经后骨质疏松症中双膦酸盐药物停药:对临床骨折风险的影响。

Bisphosphonate drug holidays in postmenopausal osteoporosis: effect on clinical fracture risk.

机构信息

Department of Rheumatology, Lille University Hospital, Rue Emile Laine, 59037, Lille, France.

Lille University - ULCO, PMOI, EA 4490, 59000, Lille, France.

出版信息

Osteoporos Int. 2017 Dec;28(12):3431-3438. doi: 10.1007/s00198-017-4215-9. Epub 2017 Sep 5.

DOI:10.1007/s00198-017-4215-9
PMID:28875236
Abstract

UNLABELLED

A cohort of 183 postmenopausal women, who had either discontinued or continued bisphosphonates (BPs) after first-line therapy, was used to investigate the relationships between "drug holiday" and clinical fracture. The risk of new clinical fractures was found to be 40% higher in women who had taken a BP "drug holiday."

INTRODUCTION

BPs are the most widely used treatment for postmenopausal osteoporosis. The optimal treatment duration, however, remains unclear. The purpose of this study was to evaluate the fracture risk in postmenopausal women with osteoporosis after discontinuing BP treatment (BP "drug holiday").

METHODS

A retrospective analysis was performed at Lille University Hospital (LUH) on postmenopausal women with osteoporosis who had taken a "drug holiday" or continued treatment after first-line BP therapy (3 to 5 years). The occurrence of new clinical fractures during follow-up was also explored. Cox proportional hazards models were used to investigate the relationships between BP "drug holiday" and the occurrence of clinical fractures, while controlling for confounding factors. Survival without new clinical fractures was analyzed using Kaplan-Meier curves and log-rank tests.

RESULTS

One hundred eighty-three women (mean age: 61.8 years; SD: 8.7) who had previously undergone BP treatment for 3 to 5 years were enrolled in our study. The patients had received alendronate (n = 81), risedronate (n = 73), zoledronic acid (n = 20), and ibandronate (n = 9). In 166 patients ("drug holiday" group: n = 31; continuous-treatment group: n = 135), follow-up ranged from 6 to 36 months (mean duration: 31.8 months; SD: 8.2). The incidences of new clinical fractures during follow-up were 16.1% (5/31) and 11.9% (16/135). After full adjustment, the hazard ratio of new clinical fractures among "drug holiday" patients was 1.40 (95% CI: 1.12-1.60; p = 0.0095).

CONCLUSIONS

After first-line BP therapy in postmenopausal women with osteoporosis, the risk of new clinical fractures was 40% higher in subjects who took a bisphosphonate drug holiday.

摘要

目的

评估绝经后骨质疏松症女性停止使用双膦酸盐(BP)治疗(BP“停药期”)后的骨折风险。

方法

在里尔大学医院(LUH)对接受一线 BP 治疗(3-5 年)后接受 BP“停药期”或继续治疗的绝经后骨质疏松症女性进行回顾性分析。还探讨了随访期间新发临床骨折的发生情况。使用 Cox 比例风险模型,在控制混杂因素的情况下,研究 BP“停药期”与临床骨折发生之间的关系。使用 Kaplan-Meier 曲线和对数秩检验分析无新发临床骨折的生存情况。

结果

本研究纳入了 183 名(平均年龄:61.8 岁;标准差:8.7)先前接受过 3-5 年 BP 治疗的女性患者。患者接受了阿伦膦酸盐(n=81)、利塞膦酸盐(n=73)、唑来膦酸(n=20)和伊班膦酸盐(n=9)治疗。在 166 名患者(“停药期”组:n=31;持续治疗组:n=135)中,随访时间为 6-36 个月(平均持续时间:31.8 个月;标准差:8.2)。随访期间新发临床骨折的发生率为 16.1%(5/31)和 11.9%(16/135)。在充分调整后,“停药期”患者新发临床骨折的风险比为 1.40(95%CI:1.12-1.60;p=0.0095)。

结论

在绝经后骨质疏松症女性接受一线 BP 治疗后,接受 BP 药物“停药期”的患者新发临床骨折的风险增加了 40%。

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