Chiu Wei-Yih, Chien Jung-Yien, Yang Wei-Shiung, Juang Jyh-Ming Jimmy, Lee Jang-Jaer, Tsai Keh-Sung
Division of Endocrinology and Metabolism (W.-Y.C., W.-S.Y., K.-S.T.) and Department of Internal Medicine (W.-Y.C., J.-Y.C., W.-S.Y., J.-M.J.J., K.-S.T.), National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei 10002, Taiwan; Department of Laboratory Medicine (W.-Y.C., K.-S.T.), and Division of Oral and Maxillofacial Surgery (J.-J.L.), Department of Dentistry, National Taiwan University Hospital, Taipei 10002, Taiwan; and Graduate Institute of Clinical Medicine (W.-Y.C., J.-Y.C., W.-S.Y.), College of Medicine, National Taiwan University, Taipei 10002, Taiwan.
J Clin Endocrinol Metab. 2014 Aug;99(8):2729-35. doi: 10.1210/jc.2013-4119. Epub 2014 Apr 23.
This study aimed to explore the possible association between osteonecrosis of the jaws (ONJ) and oral alendronate or raloxifene used for osteoporosis and to estimate its absolute and attributable risks in the Taiwanese population.
Using an electronic medical records system and manual confirmation of ONJ, we identified patients who began taking alendronate or raloxifene for osteoporosis and developed ONJ between January 2000 and April 2012.
The incidence of ONJ associated with oral alendronate for the management of osteoporosis began after 1 year of drug exposure and progressively increased with longer durations of therapy, specifically from 0.23% to 0.92% as the duration of treatment went from 2 years to 10 years. The overall frequency of ONJ related to oral alendronate over a 12-year period was 0.55%. The incidence rate of ONJ attributed to alendronate exposure was 283 per 100 000 persons per year. On multivariate Cox proportional analysis, adjusting for the potential confounders, alendronate remains an independent predictor for ONJ occurrence [hazard ratio 7.42 (1.02-54.09)] compared with raloxifene. Advanced age, drug duration, and coexisting diabetes and rheumatoid arthritis are contributing factors to the development of oral alendronate-related ONJ.
We provided the evidence to support the association of ONJ with oral alendronate used in the treatment or prevention of osteoporosis.
本研究旨在探讨颌骨坏死（ONJ）与用于治疗骨质疏松症的口服阿仑膦酸盐或雷洛昔芬之间可能存在的关联，并估计其在台湾人群中的绝对风险和归因风险。
利用电子病历系统并人工确认ONJ，我们确定了2000年1月至2012年4月期间开始服用阿仑膦酸盐或雷洛昔芬治疗骨质疏松症并发生ONJ的患者。
与用于治疗骨质疏松症的口服阿仑膦酸盐相关的ONJ发病率在药物暴露1年后开始出现，并随着治疗时间的延长而逐渐增加，具体而言，治疗时间从2年增加到10年时，发病率从0.23%增至0.92%。在12年期间，与口服阿仑膦酸盐相关的ONJ总体发生率为0.55%。阿仑膦酸盐暴露导致的ONJ发病率为每年每10万人283例。在多变量Cox比例分析中，在调整潜在混杂因素后，与雷洛昔芬相比，阿仑膦酸盐仍然是ONJ发生的独立预测因素[风险比7.42（1.02 - 54.09）]。高龄、用药时长以及并存糖尿病和类风湿关节炎是口服阿仑膦酸盐相关ONJ发生的促成因素。
我们提供了证据支持ONJ与用于治疗或预防骨质疏松症的口服阿仑膦酸盐之间的关联。
