Sealy Center on Aging, Department of Preventive Medicine and Community Health, University of Texas Medical Branch, Galveston, TX, USA.
Ann Pharmacother. 2011 Oct;45(10):1199-206. doi: 10.1345/aph.1Q239. Epub 2011 Sep 27.
Intravenous bisphosphonate therapy has been linked to osteo-necrosis of the jaw among patients with cancer. Some patients with osteoporosis also receive intravenous bisphosphonates, although at lower total doses than those with cancer.
To examine the risk for jaw osteonecrosis among a population-based cohort of older adults receiving intravenous bisphosphonates for the treatment of osteoporosis.
Using a 5% national sample of Medicare beneficiaries, we identified 2296 patients treated with intravenous infusions of bisphosphonates for osteoporosis and other metabolic bone diseases between January 1, 2000, and December 31, 2007. We matched this cohort to 6865 bisphosphonate nonusers, at a 1:3 ratio, on age, race, sex, type of bone disease, and risk factors for osteonecrosis of the jaw. Patients were followed until December 31, 2007. The jaw toxicity outcomes included operations on the facial bones or jaw and diagnosis of inflammatory conditions of the jaw.
The absolute risk at 3 years for any jaw toxicity was 0.70 events per 100 patients using bisphosphonates and 0.30 events per 100 patients not using such drugs (2-sided log rank test, p = 0.08). In multivariable survival analyses (Cox proportional hazards regression) adjusting for potential confounders, intravenous bisphosphonate use was not significantly associated with diagnoses or procedures suggestive of osteonecrosis of the jaw (p = 0.24).
Patients with osteoporosis who are treated with intravenous bisphosphonates do not appear to have a statistically significant increase in the incidence of osteonecrosis of the jaw over 3 years compared with those who do not receive such treatment. Future studies will further contribute to our understanding of the bisphosphonate risk profile, thereby allowing patients and physicians to more rigorously assess the risk-benefit ratio of this treatment across different clinical scenarios.
静脉用双膦酸盐治疗与癌症患者的颌骨坏死有关。一些骨质疏松症患者也接受静脉用双膦酸盐治疗，尽管总剂量低于癌症患者。
在接受静脉用双膦酸盐治疗骨质疏松症的老年人群中，研究颌骨坏死的风险。
使用医疗保险受益人的 5%全国样本，我们确定了 2000 年 1 月 1 日至 2007 年 12 月 31 日期间接受静脉输注双膦酸盐治疗骨质疏松症和其他代谢性骨病的 2296 例患者。我们将该队列与 6865 名未接受双膦酸盐治疗的患者按年龄、种族、性别、骨病类型和颌骨坏死风险因素进行 1:3 匹配。患者随访至 2007 年 12 月 31 日。颌骨毒性结局包括面部骨骼或颌骨手术和颌骨炎症性疾病的诊断。
使用双膦酸盐的患者 3 年内任何颌骨毒性的绝对风险为 0.70 例/100 例，未使用此类药物的患者为 0.30 例/100 例（双侧对数秩检验，p = 0.08）。在多变量生存分析（Cox 比例风险回归）中，调整潜在混杂因素后，静脉用双膦酸盐的使用与提示颌骨坏死的诊断或手术无显著相关性（p = 0.24）。
与未接受此类治疗的患者相比，接受静脉用双膦酸盐治疗的骨质疏松症患者在 3 年内颌骨坏死的发生率似乎没有统计学意义的增加。未来的研究将进一步促进我们对双膦酸盐风险特征的理解，从而使患者和医生能够在不同的临床情况下更严格地评估这种治疗的风险效益比。
