目的 挖掘真实世界中特立帕肽相关的不良事件(ADE)信号,为其临床合理安全用药提供参考。方法 调取美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)中特立帕肽2015年1月1日-2022年12月31日的数据,采用报告比值比法和贝叶斯可信区间递进神经网络法进行信号挖掘,分析其ADE发生情况。结果 共得到ADE信号299个,累及23个系统器官分类(SOC),合计报告37 332份,其中女性(76.44%)占比明显高于男性(7.06%),年龄主要分布在50岁以上的人群。累及的SOC主要包括各种肌肉骨骼及结缔组织疾病、各类检查、各类损伤、中毒及操作并发症、全身性疾病及给药部位各种反应等;报告数较多的ADE信号包括关节痛、肢体疼痛、头晕、注射部位青肿、肌痉挛等。挖掘到42个说明书未记录的新发现可疑不良反应,包括骨钙素升高、维生素D异常、肢体肿物、甲状旁腺功能亢进症、乳房钙化等。结论 特立帕肽在真实世界中发生的常见不良反应与说明书有一致性,但存在部分新发现可疑的不良反应,临床用药时应重点关注此类不良反应。

Objective To explore the signals of adverse drug event (ADE) associated with teriparatide in the real world, and to provide reference for its clinical rational use. Methods The data of teriparatide from January 1, 2015 to December 31, 2022 were collected from the US Food and Drug Administration Adverse Event Reporting System (FAERS). The reported odds ratio method and Bayesian confidence interval progressive neural network method were used for signal mining, and the occurrence of ADE was analyzed. Results A total of 299 ADE signals were obtained, involving 23 system organ categories (SOC), and a total of 37 332 reports were reported. The proportion of females (76.44%) was significantly higher than that of males (7.06%), and the age was mainly distributed in people over 50 years old. The SOC involved mainly includes various musculoskeletal and connective tissue diseases, various examinations, various injuries, poisoning and operational complications, systemic diseases, and various reactions at the drug administration site. The most frequently reported ADE signals included arthralgia, limb pain, dizziness, bruising at the injection site, and muscle spasm. A total of 42 new findings of suspected adverse reactions were found, including increased osteocalcin, abnormal vitamin D, limb masses, hyperparathyroidism, breast calcification, etc. Conclusions Common adverse reactions of teriparatide in the real world are consistent with the instructions, but there are some new suspected adverse reactions, which should be paid attention to in clinical medication.

R977.1

国家自然科学基金资助项目(82174405)