使用抗骨吸收藥物治療骨質疏鬆症產生顎骨壞死風險因子之分析

Abstract

背景與目的：藥物相關顎骨壞死（medication-related osteonecrosis of the jaw, MRONJ）為抗骨吸收藥物常見之嚴重併發症，台灣地區過去相關流行病學資料有限。本研究旨在探討台灣單一與多種抗骨吸收藥物使用者中ONJ之盛行率、發生率、風險因子與藥物使用特性，並比較不同藥物與使用順序對風險之影響。 研究方法：本研究為回溯性世代研究，自臺大醫院醫療體系醫療整合資料中心 (NTUH-iMD)擷取2009年至2022年間接受抗骨吸收藥物治療之患者資料，進行統計分析。以Kaplan-Meier法評估累積發生率，並以邏輯斯多變項回歸分析MRONJ相關危險因子。 結果：共納入19,400名單一藥物使用者，整體MRONJ盛行率為0.29%，顯著高於西方文獻所報之0.03–0.05%。Fosamax盛行率最高（0.48%），Prolia次之（0.19%）。Prolia與Fosamax併用者中，先使用Fosamax後轉為Prolia者MRONJ風險較高（1.03%）。多變項分析顯示年齡增加、女性、拔牙史、抗血管新生藥物使用及Fosamax使用為獨立危險因子。 結論：台灣地區抗骨吸收藥物相關ONJ盛行率及發生率普遍高於西方國家，且與藥物種類、使用期間與序列有關。臨床上應依據個別風險調整治療策略，以降低MRONJ之發生。

Background and Objective: Medication-related osteonecrosis of the jaw (MRONJ) is a serious complication associated with antiresorptive therapy. Epidemiological data in Taiwan remain limited. This study aimed to investigate the prevalence, incidence, risk factors, and drug-related characteristics of MRONJ among single and dual antiresorptive drug users in Taiwan and to evaluate the influence of treatment sequence. Methods: This retrospective cohort study included patients treated with antiresorptive agents between 2009 and 2022 at National Taiwan University Hospital. Patients receiving single or two-drug regimens were analyzed. Cumulative incidence was assessed using Kaplan-Meier analysis, and multivariate logistic regression was used to identify MRONJ risk factors. Results: A total of 19,400 single-drug users were included. The overall MRONJ prevalence was 0.29%, markedly higher than the 0.03–0.05% reported in Western populations. Fosamax had the highest MRONJ prevalence (0.48%), followed by Prolia (0.19%). Among patients receiving both Prolia and Fosamax, those who initiated with Fosamax had a higher MRONJ risk (1.03%) than those starting with Prolia. Multivariate analysis identified older age, female sex, tooth extraction history, antiangiogenic agent use, and Fosamax exposure as independent risk factors. Conclusion: MRONJ prevalence in Taiwan is substantially higher than in Western countries and is influenced by drug type, treatment duration, and sequence. Personalized risk assessment and tailored treatment strategies are essential to minimize MRONJ risk in clinical practice.