Hsiao Fei-Yuan, Hsu William Wei-Yuan
Graduate Institute of Clinical Pharmacy, College of Medicine, National Taiwan University.
School of Pharmacy, College of Medicine, National Taiwan University.
Jpn J Clin Oncol. 2017 Oct 1;47(10):935-941. doi: 10.1093/jjco/hyx111.
This population-based cohort study was to compare the risks of incident cancer in osteoporosis patients who used bisphosphonates, calcitonin or selective estrogen receptor modulators (SERMs).
We identified 9995 patients who were diagnosed with osteoporosis and prescribed osteoporosis drugs (bisphosphonate (n = 4675), calcitonin (n = 3993) and SERMs (n = 1327)) between 1 January 2000 and 31 December 2006 in Taiwan's National Health Insurance Research Database. Date of first prescription of osteoporosis drugs was assigned as the index date. The outcome measurement was incident cancer, defined by a first-ever inpatient visit with a primary diagnosis of cancer. All patients were followed until the occurrence of cancer. For those who did not develop cancer, we censored them at 1 year after their last prescription of osteoporosis drugs. Cox proportional hazard models were used to examine the association between risk of cancer and use of calcitonin, bisphosphonates or SERMs.
The incidence rate of cancer was 68.8, 34.0 and 29.6 per 1000 person years in the calcitonin, SERMs and bisphosphonate cohorts, respectively. Compared with bisphosphonate users, calcitonin users were associated with an increased risk of cancer (adjusted hazard ratio (HR) 2.11, 95% confidence interval (CI) 2.01-2.21, P < 0.001). SERM users were associated with an increased risk of cancer (adjusted HR 1.20, 95% CI 1.13-1.28, P < 0.001).
Our findings suggest that calcitonin is associated with an increased risk of cancer than bisphosphonate, supporting the recent warning issued by the European Medicines Agency and US Food and Drug Administration. SERMs is found to be associated with an increased risk of cancer than bisphosphonate.
这项基于人群的队列研究旨在比较使用双膦酸盐、降钙素或选择性雌激素受体调节剂（SERM）的骨质疏松症患者发生癌症的风险。
我们从台湾国民健康保险研究数据库中识别出9995例在2000年1月1日至2006年12月31日期间被诊断为骨质疏松症并开具骨质疏松症药物处方的患者（双膦酸盐组4675例，降钙素组3993例，SERM组1327例）。将首次开具骨质疏松症药物处方的日期指定为索引日期。结局指标为新发癌症，定义为首次因癌症为主诊断而住院就诊。所有患者均随访至癌症发生。对于未发生癌症的患者，在其最后一次开具骨质疏松症药物处方1年后进行截尾。采用Cox比例风险模型检验癌症风险与降钙素、双膦酸盐或SERM使用之间的关联。
降钙素组、SERM组和双膦酸盐组的癌症发病率分别为每1000人年68.8例、34.0例和29.6例。与双膦酸盐使用者相比，降钙素使用者患癌症的风险增加（调整后风险比（HR）2.11，95%置信区间（CI）2.01 - 2.21，P < 0.001）。SERM使用者患癌症的风险增加（调整后HR 1.20，95%CI 1.13 - 1.28，P < 0.001）。
我们的研究结果表明，降钙素与双膦酸盐相比，患癌症的风险增加，这支持了欧洲药品管理局和美国食品药品监督管理局最近发布的警告。发现SERM与双膦酸盐相比，患癌症的风险增加。
