双膦酸盐类药物停药时间与相关骨折风险。
Duration of Bisphosphonate Drug Holidays and Associated Fracture Risk.
机构信息
Division of Clinical Immunology & Rheumatology.
Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL.
出版信息
Med Care. 2020 May;58(5):419-426. doi: 10.1097/MLR.0000000000001294.
BACKGROUND
Discontinuation of bisphosphonates (BP) or a "drug holiday" after several years of treatment is increasingly common. However, the association of drug holiday duration with future fracture risk is unclear.
OBJECTIVES
We evaluated the rate of fracture in relation to various lengths of drug holidays among women receiving long-term BP therapy.
RESEARCH DESIGN
Observational cohort study using US Medicare data 2006-2016. Incidence rates (IRs) and Cox proportional hazards models were used to evaluate the rate and adjusted hazard ratios (aHRs) controlling for potential confounders.
SUBJECTS
Women aged 65 years and above enrolled in fee-for-service Medicare who had been adherent (≥80%) to alendronate, risedronate, or zoledronate for ≥3 years.
MEASURES
Hip, humerus, distal forearm, and clinical vertebral fracture.
RESULTS
Among 81,427 eligible women observed for a median (interquartile range) of 4.0 (2.5, 5.3) years, 28% of women underwent a drug holiday. In the alendronate cohort (73% overall), the IR of hip fracture among women who discontinued BP for >2 years was 13.2 per 1000 person-years. Risk was increased (aHR=1.3, 1.1-1.4) versus continuing therapy (IR=8.8, referent). Rates were elevated for humerus fracture with discontinuation >2 years (aHR=1.3, 1.1-1.66) and for clinical vertebral fracture with discontinuation >2 years (aHR=1.2, 1.1-1.4). Results were similar for risedronate, zoledronate, and ibandronate for hip and clinical vertebral fracture.
CONCLUSION
Discontinuing alendronate beyond 2 years was associated with increased risk of hip, humerus, and clinical vertebral fractures.
背景
在经过数年的治疗后，停止使用双膦酸盐（BP）或“药物假期”的情况越来越常见。然而，药物假期持续时间与未来骨折风险的关系尚不清楚。
目的
我们评估了长期接受 BP 治疗的女性中，不同长度的药物假期与骨折风险之间的关系。
研究设计
利用美国医疗保险数据进行的观察性队列研究，时间范围为 2006 年至 2016 年。使用发生率（IR）和 Cox 比例风险模型评估与各种药物假期相关的骨折发生率，并控制潜在混杂因素进行调整后的风险比（aHR）。
受试者
年龄在 65 岁及以上、参加医疗保险费用分担计划且至少连续 3 年依从性（≥80%）使用阿仑膦酸盐、利塞膦酸盐或唑来膦酸盐的女性。
测量指标
髋部、肱骨、远端前臂和临床椎体骨折。
结果
在中位（四分位距）随访时间为 4.0（2.5，5.3）年的 81427 名符合条件的女性中，28%的女性经历了药物假期。在阿仑膦酸盐队列（总体 73%）中，停止 BP 治疗超过 2 年的女性髋部骨折发生率为每 1000 人年 13.2 例。与继续治疗相比，风险增加（aHR=1.3，1.1-1.4）（IR=8.8，参照）。停止治疗超过 2 年时，肱骨骨折的风险增加（aHR=1.3，1.1-1.66），临床椎体骨折的风险增加（aHR=1.2，1.1-1.4）。对于利塞膦酸盐、唑来膦酸盐和伊班膦酸盐，髋部和临床椎体骨折的结果相似。
结论
阿仑膦酸盐停药超过 2 年与髋部、肱骨和临床椎体骨折风险增加相关。
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