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双膦酸盐的依从性与髋部骨折的长期风险:一项使用真实世界数据的巢式病例对照研究。

Adherence With Bisphosphonates and Long-Term Risk of Hip Fractures: A Nested Case-Control Study Using Real-World Data.

作者信息

Shalev Varda, Sharman Moser Sarah, Goldshtein Inbal, Yu Jingbo, Weil Clara, Ish-Shalom Sophia, Rouach Vanessa, Chodick Gabriel

机构信息

1 Maccabi Healthcare Services, Tel Aviv, Israel.

2 Tel Aviv University, Tel Aviv, Israel.

出版信息

Ann Pharmacother. 2017 Sep;51(9):757-767. doi: 10.1177/1060028017710482. Epub 2017 May 23.

Abstract

BACKGROUND

Hip fracture is a major complication of osteoporosis. Bisphosphonate medication is the mainstay of treatment for osteoporosis. However, concerns have been raised regarding the effectiveness of bisphosphonates in reducing hip fracture risk after long-term use, particularly among patients with suboptimal adherence.

OBJECTIVE

To examine the association between adherence with bisphosphonate therapy and long-term risk of hip fracture.

METHODS

Included in the present nested case-control study were osteoporotic women (n = 14 357) who initiated bisphosphonate therapy in 2000-2010 and were retrospectively followed for incident hip fracture through November 2014. Within this cohort, each case of primary hip fractures was individually matched to 3 controls without a primary hip fracture. Proportion of follow-up days covered (PDC) with bisphosphonates was calculated from bisphosphonate purchases. Adherence was categorized into the following groups: purchase of 1 or 2 months' supply (reference group), at least 3 months' supply to PDC ≤20%, PDC >20% to ≤80%, PDC >80% to ≤100%.

RESULTS

Included in the analysis were 426 case-control groups with a mean age (SD) of 73.7 years (7.9). Compared with the reference group, PDC of 80% to 100% with bisphosphonates was associated with a significant reduction in hip fracture risk for patients with 8 to 15 years of follow-up (OR = 0.39; 95% CI = 0.18-0.87). Among patients with a follow-up of up to 3 years, OR was 0.58 (95% CI = 0.31-1.06).

CONCLUSIONS

Adherence with bisphosphonates among osteoporotic patients is associated with lower risk of hip fracture, with no indication of diminished effectiveness with long-term use.

摘要

背景

髋部骨折是骨质疏松症的主要并发症。双膦酸盐药物是治疗骨质疏松症的主要手段。然而,长期使用双膦酸盐在降低髋部骨折风险方面的有效性引发了担忧,尤其是在依从性欠佳的患者中。

目的

探讨双膦酸盐治疗的依从性与髋部骨折长期风险之间的关联。

方法

本巢式病例对照研究纳入了2000年至2010年开始接受双膦酸盐治疗的骨质疏松症女性(n = 14357),并对其进行回顾性随访,直至2014年11月观察髋部骨折的发生情况。在该队列中,每例原发性髋部骨折病例均与3例无原发性髋部骨折的对照个体匹配。根据双膦酸盐的购买量计算双膦酸盐覆盖的随访天数比例(PDC)。依从性分为以下几组:购买1或2个月的供应量(参照组)、至少3个月的供应量且PDC≤20%、PDC>20%至≤80%、PDC>80%至≤100%。

结果

纳入分析的有426个病例对照组,平均年龄(标准差)为73.7岁(7.9)。与参照组相比,双膦酸盐PDC为80%至100%与随访8至15年的患者髋部骨折风险显著降低相关(比值比[OR]=0.39;95%置信区间[CI]=0.18 - 0.87)。在随访长达3年的患者中,OR为0.58(95%CI = 0.31 - 1.06)。

结论

骨质疏松症患者对双膦酸盐的依从性与较低的髋部骨折风险相关,没有迹象表明长期使用会降低其有效性。

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