全国唑来膦酸致颌骨骨坏死不良反应监测数据分析

Analysis of national monitoring data of adverse drug reactions related to zoledronic acid-related osteonecrosis of the jaw

目的 描述我国唑来膦酸致颌骨骨坏死(ONJ)不良反应的报告特征,探索影响因素,为风险控制提供建议。方法 对2004年1月1日至2021年6月30日期间国家药品不良反应监测系统收到的唑来膦酸致ONJ不良反应报告进行统计分析。结果 共73份唑来膦酸致ONJ报告,90.41%为严重报告。2份信息缺失,其余71份中,94.37%(67/71)为肿瘤用药,5.63%(4/71)为骨质疏松症用药。肿瘤报告以中老年女性为主,44.78%的原发肿瘤为乳腺癌,59.70%有合并治疗,41.79%有牙科手术史,52.24%的ONJ转归为痊愈或好转。4份骨质疏松症报告均为有牙科手术史的老年女性。结论 我国唑来膦酸致ONJ报告较为罕见,但多为严重报告。肿瘤患者多于骨质疏松症患者,牙科手术史是需要重视的危险因素,合并治疗对ONJ的发生可能有一定影响。药品上市许可持有人、医务人员、患者均应重视唑来膦酸的ONJ风险,采取多种措施保障用药安全。

Objective To describe the characteristics of zoledronic acid related osteonecrosis of the jaw(ONJ) in China,explore the risk factors, and to give tips about risk control. Methods Zoledronic acid related ONJ reports received by the National Adverse Drug Reaction Monitoring System between January 1, 2004 and June 30, 2021 were analyzed to identify the characteristics of ONJ reports. Results A total of 73 zoledronic acid related ONJ reports were retrieved, 90.41% of which were serious reports. The information about 2 cases was missing. Among the 71 cases reported, 94.37%(67/71)were related to anti-tumor drugs and 5.63%(4/71) anti-osteoporosis drugs. Cancer-related reports mainly involved middle-aged and elderly women. 44.78% of primary tumors were breast cancer, 59.70% of the patients had received concomitant therapies, 41.79% had undergone dental surgery, and 52.24% had fully recovered or were recovering. The four reports about osteoporosis patients were all elderly women with a dental surgery history. Conclusion Zoledronic acid related ONJ is rarely reported in China, most of the reports involve serious cases. There have been more reports from patients with cancer than from patients with osteoporosis. A dental surgery history is an important risk factor for ONJ, and the concomitant therapy might have some effect on the onset of ONJ. The risk of ONJ induced by zoledronic acid deserves more attention and effective measures should be taken to ensure drug safety.