Epidemiology, RTI Health Solutions, Research Triangle Park, NC, USA.
Pharmacoepidemiol Drug Saf. 2012 Aug;21(8):810-7. doi: 10.1002/pds.3292. Epub 2012 Jun 19.
To quantify the incidence of osteonecrosis of the jaw (ONJ) by bisphosphonate exposure among two cohorts of patients.
In a retrospective cohort study, we identified cohort members via health insurance claim diagnosis codes and identified potential cases of ONJ that were confirmed with medical record review. One cohort included patients aged ≥40 years with breast or prostate cancer or multiple myeloma; the other cohort included men aged ≥60 years and women ≥50 years with osteoporosis. For each cohort, we calculated sex- and age-standardized incidence of ONJ by exposure to oral bisphosphonates and intravenous bisphosphonates.
In the cancer cohort (n = 46 542), sex- and age-standardized incidence of ONJ (n = 26 probable or possible cases) adjusted for abstraction proportion was 0.29 per 1000 person-years (95% confidence interval [CI], 0.07-0.52) among those unexposed to bisphosphonates and 5.3 (95%CI, 1.9-8.7) after intravenous bisphosphonate use. Controlling for covariates, the rate ratio for intravenous use versus no use was 8.8 (95%CI, 2.0-38). Patients with multiple myeloma had a rate 4.5 times that of patients with breast cancer. In the osteoporosis cohort (n = 31 244), sex- and age-standardized ONJ (n = 11 probable or possible cases) incidence was 0.26 per 1000 person-years (95%CI, 0.06-0.47) among those unexposed to bisphosphonate and 0.15 (95%CI, 0.00-0.36) after oral bisphosphonate use.
Among patients with selected cancers, incidence of ONJ was higher among those with multiple myeloma and users of intravenous bisphosphonates.
通过对两个患者队列的双膦酸盐暴露情况，定量评估颌骨坏死（ONJ）的发生率。
在一项回顾性队列研究中，我们通过医疗保险索赔诊断代码确定队列成员，并通过病历审查确认 ONJ 的潜在病例。一个队列包括年龄≥40 岁的乳腺癌、前列腺癌或多发性骨髓瘤患者；另一个队列包括年龄≥60 岁的男性和≥50 岁的女性骨质疏松症患者。对于每个队列，我们通过口服和静脉双膦酸盐暴露情况计算了 ONJ 的性别和年龄标准化发生率。
在癌症队列（n=46542）中，未使用双膦酸盐和使用静脉双膦酸盐后，ONJ 的性别和年龄标准化发生率（n=26 例可能或确诊病例）经提取比例校正后分别为 0.29/1000人年（95%CI，0.07-0.52）和 5.3（95%CI，1.9-8.7）。控制协变量后，静脉使用与未使用的比率比为 8.8（95%CI，2.0-38）。多发性骨髓瘤患者的发生率是乳腺癌患者的 4.5 倍。在骨质疏松症队列（n=31244）中，未使用双膦酸盐和使用口服双膦酸盐后，ONJ 的性别和年龄标准化发生率（n=11 例可能或确诊病例）分别为 0.26/1000人年（95%CI，0.06-0.47）和 0.15（95%CI，0.00-0.36）。
在患有特定癌症的患者中，多发性骨髓瘤患者和静脉双膦酸盐使用者的 ONJ 发生率更高。
