基于FDA不良事件报告系统数据库的左炔诺孕酮上市后药物警戒研究  

Postmarketing pharmacovigilance study of levonorgestrel based on FDA adverse event reporting system(FAERS)database

作　　者：高慧[1] 吴航 Gao Hui;Wu Hang(Heze Medical College,Heze 274000,China;Heze University,Heze 274000,China)

机构地区：[1]菏泽医学专科学校,山东菏泽274000 [2]菏泽学院,山东菏泽274000

出　　处：《实用药物与临床》2025年第3期174-177,共4页Practical Pharmacy and Clinical Remedies

基　　金：菏泽医学专科学校校级课题(H23Z04)。

摘　　要：目的利用美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)数据库中左炔诺孕酮不良反应的记录,挖掘和评估左炔诺孕酮上市后的不良反应。方法提取2004年第1季度至2024年第2季度FAERS数据库中以左炔诺孕酮为首要怀疑药物的不良事件报告,采用报告比值比(ROR)、比例报告比值比(PRR)、贝叶斯可信区间递进神经网络(BCPNN)、多项式伽马泊松分布缩减(MGPS)计算左炔诺孕酮不良事件的信号强度。结果左炔诺孕酮的不良反应报告主要来自18~44岁的女性。左炔诺孕酮的不良反应以生殖系统和乳腺疾病最为常见。其中卵巢囊肿破裂、乳腺囊肿、溢乳、焦虑、宫颈上皮内病变和特皮性颅内压增高呈现出阳性的药物警戒信号,这些不良反应并未被说明书所记录。结论卵巢囊肿破裂、乳腺囊肿、溢乳、焦虑、宫颈上皮内病变和特发性颅内压增高可能是左炔诺孕酮的潜在不良反应。临床医师和患者在使用左炔诺孕酮时,应当注意这些不良反应,降低左炔诺孕酮的用药风险。Objective The post-marketing adverse reactions of levonorgestrel were mined and assessed by utilizing the reports in the FAERS database.Methods Adverse event reports associated with levonorgestrel which was regarded as the primary suspect drug were extracted from the FAERS database spanning from the first quarter of 2004 to the second quarter of 2024.Signal strength of levonorgestrel adverse events was assessed by using ROR,PRR,BCPNN,and MGPS.Results Adverse reactions of levonorgestrel were predominantly reported among women aged 18~44 years.The most prevalent adverse reactions of levonorgestrel were related to the reproductive system and breast diseases.Among them,positive pharmacovigilance signals were observed for ovarian cyst rupture,breast cysts,galactorrhea,anxiety,cervical intraepithelial lesions and idiopatihic intracranial hypertension;however,these specific adverse reactions were not documented in the package insert.Conclusion Ovarian cyst rupture,breast cysts,galactorrhea,anxiety,cervical intraepithelial lesions and idiopathic intracranial hypertension may be the potential adverse reactions of levonorgestrel.Clinicians and patients should be mindful of these potential adverse reactions when using levonorgestrel in order to reduce the medication risk of levonorgestrel.

关 键 词：左炔诺孕酮 药物警戒 不良事件 FDA不良事件报告系统 

分 类 号：R71[医药卫生—妇产科学]