地舒单抗不良反应信号挖掘与分析

目的:利用真实世界数据评价地舒单抗的安全性,为其临床合理安全用药提供参考。方法:调取美国FDA不良事件报告系统(FAERS)中地舒单抗2015年至2020年的数据,采用报告比值比法和比例报告比法进行信号挖掘,分析其不良反应发生情况。结果:共得到不良反应信号158个,其中107个未在说明书中收录。不良反应发生频次较高的主要集中在肌肉骨骼疾病、全身整体疾病、胃肠疾病和代谢及营养疾病方面;不良反应信号较强的主要集中在肿瘤、肌肉骨骼疾病、内分泌疾病等方面;同时发现了一些未收录于说明书中的不良反应,如口腔良性肿瘤、甲状旁腺功能亢进、碱性磷酸酶降低、高胆固醇血症、关节炎等。结论:临床使用地舒单抗时应重点关注肌肉骨骼疾病、全身整体疾病、肿瘤、胃肠疾病和代谢及营养疾病等方面的不良反应,并采取一定的预防和治疗措施,减少不良反应带来的伤害。

Data mining and analysis of adverse reaction signals of denosumab

OBJECTIVE To evaluate the safety of denosumab by using real-world data and provide reference for clinical rational and safe drug use.METHODS The data of denosumab in FDA Adverse Event Reporting System (FAERS) were collected from 2015 to 2020 and the reported odds ratio (ROR) and proportional reporting ratio (PRR) were used for signal mining to analyze the occurrence of adverse reactions.RESULTS Totally 158 adverse reaction signals were obtained, of which 107 were not included in the manual of denosumab. The high frequency of adverse reactions of denosumab mainly focused on musculoskeletal diseases, systemic diseases, gastrointestinal diseases, metabolic and nutritional diseases. The strong adverse reaction signals were mainly concentrated in tumors, musculoskeletal diseases, endocrine diseases and so on. It was also found that such adverse reactions as oral benign tumors, hyperparathyroidism, alkaline phosphatase decreased, hypercholesterolemia and arthritis, etc., were not mentioned in the manual.CONCLUSION The clinical use of denosumab should focus on the adverse reactions of musculoskeletal diseases, systemic diseases, tumors, gastrointestinal diseases, metabolic and nutritional diseases, and take certain preventive and therapeutic measures to reduce the harm caused by the adverse reactions.