目的:探讨地诺塞马(Dmab)和唑来膦酸(ZA)的不良事件,比较他们的联想优势,探讨潜在的应用,为临床提供参考。方法:我们从2004年1月至2022年11月收集了FAERS的数据,并使用ROR值挖掘了Dmab和ZA的AE信号。我们比较了相同AE的信号强度,并研究了标签外使用。我们还检查了他们在乳腺癌和前列腺癌辅助治疗中的不良事件。结果:在FAERS数据库中分析了154,735份主要可疑药物报告(Dmab:117,857;ZA:36,878)。Dmab和ZA有333和1379个AE信号,有189个重叠。Dmab的AE包括死亡(ROR:3.478),颌骨坏死(ROR:53.025),背痛(ROR:2.432),牙齿疾病(ROR:16.18),骨痛(ROR:6.523)。对于ZA来说,不良事件包括骨坏死(ROR:104.866),死亡(ROR:3.645),疼痛(ROR:3.963),颌骨坏死(ROR:91.744),拔牙(ROR:142.143)。在重叠信号中,Dmab在颌骨外生症中显示出更高的强度(ROR:182.66vs.5.769),非典型骨折(ROR:55.589vs.9.123),和非典型股骨骨折(ROR:49.824vs.4.968).ZA在脓肿颌骨中表现出更强的关联(ROR:84.119vs.11.12),牙龈溃疡(ROR:74.125vs.4.827),骨形成增加(ROR:69.344vs.3.218).此外,我们确定了Dmab的528个标签外用途和ZA的206个标签外用途,Dmab主要用于前列腺癌(1.04%),乳腺癌(1.03%),和关节炎(0.42%),而乳腺癌中的ZA(3.21%),前列腺癌(2.48%),肿瘤恶性(0.52%)。对于乳腺癌治疗中的Dmab,不良事件包括死亡(11.6%),疾病进展(3.3%),中性粒细胞减少症(2.7%),而ZA包括死亡(19.8%),情绪障碍(12.9%),骨髓炎(11.7%)。对于前列腺癌的治疗,Dmab的不良事件为死亡(8.9%),前列腺癌转移(1.6%),肾损害(1.7%),而ZA包括死亡(34.4%),一般身体健康恶化(19.9%),血红蛋白下降(18.9%)。结论:我们对FAERS数据库的分析提供了上市后的监测数据,并揭示了Dmab和ZA在某些常见AE中报告的AE信号的不同强度。值得注意的是,这两种药物都有潜在的标签外应用,这可能会引入新的AE。这突出了使用Dmab和ZA标签外进行安全监控的必要性。
Objective: To investigate adverse events (AEs) associated with denosumab (Dmab) and zoledronic acid (ZA), compare their association strengths, and explore potential applications to provide clinical reference. Methods: We collected data from FAERS from January 2004 to November 2022 and mined AE signals for Dmab and ZA using ROR values. We compared signal intensity for same AEs and investigated off-label use. We also examined their AEs in adjuvant therapy for breast and prostate cancer. Results: 154,735 reports of primary suspect drugs were analyzed in the FAERS database (Dmab: 117,857; ZA: 36,878). Dmab and ZA had 333 and 1,379 AE signals, with 189 overlaps. The AEs of Dmab included death (ROR:3.478), osteonecrosis of jaw (ROR:53.025), back pain (ROR:2.432), tooth disorder (ROR:16.18), bone pain (ROR:6.523). For ZA, the AEs included osteonecrosis (ROR:104.866), death (ROR: 3.645), pain (ROR:3.963), osteonecrosis of jaw (ROR: 91.744), tooth extraction (ROR: 142.143). Among overlap signals, Dmab showed higher strength in exostosis of the jaw (ROR: 182.66 vs. 5.769), atypical fractures (ROR: 55.589 vs. 9.123), and atypical femur fractures (ROR:49.824 vs. 4.968). And ZA exhibited stronger associations in abscess jaw (ROR: 84.119 vs. 11.12), gingival ulceration (ROR: 74.125 vs. 4.827), increased bone formation (ROR: 69.344 vs. 3.218). Additionally, we identified 528 off-label uses for Dmab and 206 for ZA, with Dmab mainly used in prostate cancer (1.04%), breast cancer (1.03%), and arthritis (0.42%), while ZA in breast cancer (3.21%), prostate cancer (2.48%), and neoplasm malignant (0.52%). For Dmab in breast cancer treatment, AEs included death (11.6%), disease progression (3.3%), and neutropenia (2.7%), while for ZA included death (19.8%), emotional disorder (12.9%), osteomyelitis (11.7%). For prostate cancer treatment, Dmab`s AEs were death (8.9%), prostate cancer metastatic (1.6%), renal impairment (1.7%), while ZA`s included death (34.4%), general physical health deterioration (19.9%), and hemoglobin decreased (18.9%). Conclusion: Our analysis of FAERS database provided postmarketing surveillance data and revealed different strengths of reported AE signals between Dmab and ZA in some of their common AEs. It\'s also worth noting that both drugs have potential off-label applications, which could introduce new AEs. This highlights the necessity for safety monitoring when using Dmab and ZA off-label.