基于FAERS数据库的老年人使用三叉神经痛治疗药物的眼毒性信号挖掘研究

Ocular Toxicity Signal Mining of Trigeminal Neuralgia Drugs in The Elderly Based on FAERS Database

关键词:  FAERS  老年  三叉神经痛  眼器官疾病不良事件  信号挖掘  报告比值比法  综合标准法

Key words:  FAERS  elderly  trigeminal Neuralgia  eye disorders adverse event  signal mining  ROR  MHRA

摘要:

目的　基于FAERS数据库对老年人使用三叉神经痛（TN）治疗药物的眼毒性进行信号挖掘，探索不良事件（AE）发生的危险因素，期望为临床安全应用TN治疗药物提供参考。 方法　提取FAERS数据库 2019年第1季度至2024 年第2季度共22个季度的拉莫三嗪、普瑞巴林、加巴喷丁、卡马西平、奥卡西平相关老年患者眼毒性报告数据，利用报告比值比（ROR）法和综合标准（MHRA）法进行数据挖掘。得到有信号首选语（PT）后，再利用国际医学用语词典（MedDRA）规范进行汉化及高位语（HLT）归类。 结果　在FAERS数据库老年人发生眼毒性的报告中，以拉莫三嗪为首要怀疑药物（PS）的报告92例，其中有信号PT共8个，涉及7个HLT；以普瑞巴林为PS的报告1149例，其中有信号PT共19个，涉及13个HLT；以加巴喷丁为PS的报告405例，其中有信号PT共10个，涉及6个HLT；以卡马西平为PS的报告83例，其中有信号PT共6个，涉及4个HLT；以奥卡西平为PS的报告17例，其中有信号PT共1个。报告量前两位的HLT是视觉损害和失明（色盲除外）和视觉障碍（不另分类）。女性老年患者使用5种TN治疗药物发生眼毒性的报告均高于男性，上报者多为消费者，给药途径多为口服，近年来，报告数量有逐渐减少趋势。不良事件发病时间多在用药后前1个月。 结论　老年女性可能是眼毒性发生的危险因素，对用药后前1个月的重点监测可能是预防老年患者使用5种TN治疗药物发生眼毒性的关键。老年患者使用5种TN治疗药物发生眼毒性累及HLT具有差异性，可为临床药物选择提供参考，有利于促进合理用药。

Abstract:

OBJECTIVE Signal mining of ocular toxicity of trigeminal neuralgia (TN) therapeutics in older adults based on the FAERS database were performed to explore the risk factors for the occurrence of adverse event (AE), with the expectation of providing a reference for the safe clinical application of TN therapeutics. METHODS The reported data on ocular toxicity of lamotrigine, pregabalin, gabapentin, carbamazepine, oxcarbazepine-related ocular toxicity in elderly patients from the FAERS database for a total of 22 quarters from first quarter of 2019 to second quarter of 2024 were extracted, and data mining were carried out by utilizing reporting odds ratio (ROR) and healthcare products regulatory agency (MHRA). After obtaining signaled preferred terms (PT), the Chinese language and high level term (HLT) are classified by the International Medical Dictionary of Terms (MedDRA). RESULTS Of the reports of ocular toxicity occurring in older adults in the FAERS database, 92 cases were reported with lamotrigine as the primary suspect drug (PS), with a total of 8 signaling PT involving 7 HLT; 1149 cases were reported with pregabalin as the PS, with a total of 19 signaling PT involving 13 HLT; 405 cases were reported with gabapentin as the PS, with a total of 10 involving 6 HLT; 83 cases were reported with carbamazepine as the PS, with a total of 6 signaling PT involving 4 HLT; and 17 cases were reported with oxcarbazepine as the PS, with a total of 1 signaling PT. The top two reported HLT were visual impairment and blindness (excl colour blindness) and Visual disorders NEC. Reports of ophthalmotoxicity with all five TN therapeutic agents were higher in female elderly patients than in males, with most of the reports coming from consumers and most of the routes of administration being oral, with a trend towards a gradual decrease in the number of reports in recent years. The onset of adverse events was mostly in the first month after drug administration. CONCLUSION Older women may be a risk factor for the occurrence of ophthalmotoxicity, and focused monitoring of the first month after drug administration may be key to preventing the occurrence of ophthalmotoxicity in elderly patients using 5 TN therapeutic agents. The occurrence of ophthalmotoxicity involving HLT in elderly patients using the five TN therapeutic agents has a differential effect, which may provide a reference for clinical drug selection and help to promote the rational use of drugs.