| 中文摘要 |
背景：抗骨吸收藥物（anti-resorptive medications, ARMs），包括雙磷酸鹽類與Denosumab，廣泛用於骨質疏鬆症及癌症相關骨病變治療，但其可能導致藥物相關性顎骨壞死（medication-related osteonecrosis of the jaw, MRONJ）。本研究旨在評估台灣地區MRONJ的發生率及其危險因子。
方法：本研究回顧性分析2006至2017年間「全民健康保險研究資料庫（NHIRD）」與「重大傷病資料庫」中的資料，納入接受ARMs治療之骨質疏鬆症或癌症病人。MRONJ的定義為8週內出現三次診斷紀錄。每位ARM使用者依年齡、性別與指標年度，與四位非使用者配對（1:4）。計算MRONJ發生率與發生率比（IRR），並以Cox比例風險模型分析調整後的風險比（aHR）。
結果：共納入356,570名骨質疏鬆症及143,934名癌症病人。相較於非使用者，ARM使用者的MRONJ發生率顯著較高。在骨質疏鬆症族群中，Denosumab使用者的MRONJ發生率最高（IRR1.66）；在癌症族群中，使用雙磷酸鹽者風險最高（IRR 3.23）。MRONJ發生與使用ARMs有顯著相關（骨質疏鬆症族群：aHR 1.42，95% CI：1.26–1.59；癌症族群：aHR 2.98，95% CI：2.55–3.47），女性、糖尿病與自體免疫風濕疾病亦為相關危險因子。亞組分析顯示，同時接受靜脈與口服雙磷酸鹽治療的骨質疏鬆病人，其MRONJ風險最高（aHR 2.28，95% CI：1.63–3.20）。
結論：在台灣的骨質疏鬆與癌症病人中，接受抗骨吸收藥物治療與MRONJ發生風險增加有獨立相關性。建議針對高風險病人進行密切監測。 |
| 英文摘要 |
Background: Anti-resorptive medications (ARMs), including bisphosphonates and denosumab, are widely used for osteoporosis and cancer-related bone disorders but carry the risk of medication-related osteonecrosis of the jaw (MRONJ). This study assessed MRONJ incidence and risk factors in Taiwan.
Methods: Data from the National Health Insurance Research Database (NHIRD) and Registry for Catastrophic Illness File from 2006–2017 were analyzed retrospectively. Patients diagnosed with osteoporosis or cancer who received ARMs were included. MRONJ was confirmed when a patient had three diagnostic records within eight weeks. ARM users were matched to non-users by age, sex, and index year (1:4). MRONJ incidence rates and incidence rate ratios (IRRs) were calculated, and associations were assessed using Cox proportional hazards models to determine adjusted hazard ratios (HRs) for MRONJ risk.
Results: Among 356,570 osteoporosis and 143,934 cancer patients, ARM users had a significantly higher incidence of MRONJ compared to non-users. In the osteoporosis cohort, denosumab users had the highest MRONJ incidence (IRR 1.66), while in the cancer cohort, bisphosphonate users had the highest incidence (IRR 3.23). MRONJ was significantly associated with ARM use (osteoporosis cohort: aHR 1.42, 95% CI: 1.26–1.59; cancer cohort: aHR 2.98, 95% CI: 2.55–3.47), female sex, diabetes, and autoimmune rheumatic disease. Subgroup analysis revealed that osteoporosis patients received both intravenous and oral bisphosphonate treatments had the highest MRONJ risk (aHR 2.28, 95% CI: 1.63–3.20).
Conclusion: ARMs exposure is independently associated with increased MRONJ risk in Taiwanese osteoporosis and cancer populations. High-risk patients require close monitoring. |
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