Homero Contreras-Salinas, María Soledad Romero-López, Oscar Olvera-Montaño, Lourdes Yolotzin Rodríguez-Herrera
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引用次数: 0
摘要
目的:本研究旨在通过对食品药品管理局不良事件报告系统(FAERS)数据库的数据挖掘,确定眼科前列腺素类似物的安全信号:本研究旨在通过对食品药品管理局不良事件报告系统(FAERS)数据库进行数据挖掘,识别眼科前列腺素类似物的安全信号:方法: 对FAERS数据库中的下列眼科药物进行数据挖掘搜索:拉坦前列腺素、曲伏前列腺素、他氟前列腺素和比马前列腺素,通过比例报告比、报告OR、贝叶斯置信度传播神经网络、信息成分0.25和χ2进行安全信号检测:12个首选术语在统计学上相关:糖尿病,n=2;听力减退,n=2;恶性纵隔肿瘤,n=1;血免疫球蛋白E增加,n=1;白内障,n=1;眼睑痉挛,n=1;全血细胞计数异常,n=1;皮肤脱落,n=1;胸部不适,n=1;口干,n=1:研究的局限性:FAERS 数据库的局限性,如病例的因果关系不确定、报告不足以及没有限制只有医疗专业人员才能报告此类事件等,都可能会影响统计结果。这些局限性与眼科药物分析尤为相关,因为它们会影响数据的准确性和可靠性,可能导致结果有偏差或不完整:我们的研究结果揭示了恶性纵隔肿瘤、全血细胞计数异常、血免疫球蛋白 E 增高、糖尿病、眼睑痉挛、白内障、胸部不适和口干之间因生物学合理性而可能存在的关系;因此,无论是为了反驳安全信号还是发现新的风险,继续调查药物与事件之间可能存在的关联都是有意义的。
Prostaglandin analogues signal detection by data mining in the FDA Adverse Event Reporting System database.
Objective: This study aims to identify safety signals of ophthalmic prostaglandin analogues through data mining the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
Methods: A data mining search by proportional reporting ratio, reporting OR, Bayesian confidence propagation neural network, information component 0.25 and χ2 for safety signals detection was conducted to the FAERS database for the following ophthalmic medications: latanoprost, travoprost, tafluprost and bimatoprost.
Results: 12 preferred terms were statistically associated: diabetes mellitus, n=2; hypoacusis, n=2; malignant mediastinal neoplasm, n=1; blood immunoglobulin E increased, n=1; cataract, n=1; blepharospasm, n=1; full blood count abnormal, n=1; skin exfoliation, n=1; chest discomfort, n=1; and dry mouth, n=1.
Limitation of the study: The FAERS database's limitations, such as the undetermined causality of cases, under-reporting and the lack of restriction to only health professionals reporting this type of event, could modify the statistical outcomes. These limitations are particularly relevant in the context of ophthalmic drug analysis, as they can affect the accuracy and reliability of the data, potentially leading to biased or incomplete results.
Conclusions: Our findings have revealed a potential relationship due to the biological plausibility among malignant mediastinal neoplasm, full blood count abnormal, blood immunoglobulin E increased, diabetes mellitus, blepharospasm, cataracts, chest discomfort and dry mouth; therefore, it is relevant to continue investigating the possible drug-event association, whether to refute the safety signal or identify a new risk.