目的:探讨经皮椎体强化术(PVA)后骨质疏松性椎体压缩骨折(OVCF)患者抗骨质疏松药物的使用情况和再骨折发生率,并评价PVA后使用Denosumab对患者的实际治疗效果。这项研究旨在为脊柱外科医生提供来自现实世界场景的经验见解,以增强OVCF患者骨骼健康的管理。
方法:本回顾性队列研究基于来自美国MarketScan和Optum数据库的数据。纳入了在2013年1月至2020年3月期间接受PVA治疗OVCF的55-90岁女性患者,并从手术后当天开始随访。接受至少一个剂量的denosumab的患者被纳入denosumab队列,并根据他们是否接受第二剂量的denosumab进一步分为治疗组和治疗组,随访从指数日开始(第一次denosumab剂量后225天)。在这项研究中,非治疗组作为对照组.PVA后再断裂发生率,使用抗骨质疏松药物的患者在总研究人群中的比例,分析denosumab队列中指数日之后的再骨折发生率。
结果:来自MarketScan和Optum数据库的13,451名和21,420名患者,分别,包括在内。在denosumab队列中,在指数日之后的3年内临床骨质疏松性骨折的累积发生率在治疗组明显低于非治疗组(MarketScan数据库:23.0%vs39.0%,p=0.002;Optum数据库:28.2%对40.0%,p=0.023)。在治疗组的临床椎体骨折的累积发生率也低于在非治疗组,在MarketScan数据库中存在显著差异(14.4%vs25.5%,p=0.002),并且在Optum数据库中发现了数字差异(20.2%对27.5%,p=0.084)。术后6个月使用抗骨质疏松药物的患者比例较低,只有大约7%的人使用denosumab,13%-15%的人口服双膦酸盐。
结论:绝经后妇女再骨折率高,PVA后使用抗骨质疏松药物的比例低。PVA后继续denosumab治疗与骨质疏松和临床椎体骨折的风险较低相关。因此,denosumab可能是PVA术后骨质疏松症患者的治疗选择。
OBJECTIVE: To investigate the use of anti-osteoporotic agents and refracture incidence in patients with osteoporotic vertebral compression fracture (OVCF) following percutaneous vertebral augmentation (PVA) and to evaluate the real-world treatment of patients using
denosumab following PVA. This study aims to provide spine surgeons with empirical insights derived from real-world scenarios to enhance the management of bone health in OVCF patients.
METHODS: This retrospective cohort study was based on data from the MarketScan and Optum databases from the USA. Female patients aged 55-90 years who underwent PVA for OVCF between January 2013 and March 2020 were included and followed up from the day after surgery. Patients who received at least one dose of
denosumab were included in the
denosumab cohort and were further divided into the on-treatment and off-treatment groups according to whether they received a second dose of denosumab, with follow-up beginning on the index day (225 days after the first
denosumab dose). In this study, the off-treatment group was considered as the control group. Refracture incidence after PVA, the proportion of patients using anti-osteoporotic agents in the total study population, and refracture incidence after the index day in the denosumab cohort were analyzed.
RESULTS: A total of 13,451 and 21,420 patients from the MarketScan and Optum databases, respectively, were included. In the denosumab cohort, the cumulative incidence of clinical osteoporotic fractures within 3 years after the index day was significantly lower in the on-treatment group than in the off-treatment group (MarketScan database: 23.0% vs 39.0%, p = 0.002; Optum database: 28.2% vs 40.0%, p = 0.023). The cumulative incidence of clinical vertebral fractures was also lower in the on-treatment group than in the off-treatment group, with a significant difference in the MarketScan database (14.4% vs 25.5%, p = 0.002) and a numerical difference was found in the Optum database (20.2% vs 27.5%, p = 0.084).The proportion of patients using anti-osteoporotic agents was low at 6 months postoperatively, with only approximately 7% using denosumab and 13%-15% taking oral bisphosphonates.
CONCLUSIONS: Postmenopausal women have a high refracture rate and a low proportion of anti-osteoporotic drug use after PVA. Continued
denosumab treatment after PVA is associated with a lower risk of osteoporotic and clinical vertebral fractures. Therefore,
denosumab may be a treatment option for patients with osteoporosis after PVA.