目的 挖掘真實世界中特立帕肽相關的不良事件(ADE)信號,為其臨床合理安全用藥提供參考。方法 調取美國食品藥品監(jiān)督管理局(FDA)不良事件報告系統(tǒng)(FAERS)中特立帕肽2015年1月1日-2022年12月31日的數(shù)據(jù),采用報告比值比法和貝葉斯可信區(qū)間遞進神經網絡法進行信號挖掘,分析其ADE發(fā)生情況。結果 共得到ADE信號299個,累及23個系統(tǒng)器官分類(SOC),合計報告37 332份,其中女性(76.44%)占比明顯高于男性(7.06%),年齡主要分布在50歲以上的人群。累及的SOC主要包括各種肌肉骨骼及結締組織疾病、各類檢查、各類損傷、中毒及操作并發(fā)癥、全身性疾病及給藥部位各種反應等;報告數(shù)較多的ADE信號包括關節(jié)痛、肢體疼痛、頭暈、注射部位青腫、肌痙攣等。挖掘到42個說明書未記錄的新發(fā)現(xiàn)可疑不良反應,包括骨鈣素升高、維生素D異常、肢體腫物、甲狀旁腺功能亢進癥、乳房鈣化等。結論 特立帕肽在真實世界中發(fā)生的常見不良反應與說明書有一致性,但存在部分新發(fā)現(xiàn)可疑的不良反應,臨床用藥時應重點關注此類不良反應。

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

國家自然科學基金資助項目(82174405)