利用不适当性分析识别与美国 FDA 批准药物相关的新信号（2013 年）。
Identification of Novel Signals Associated with US-FDA Approved Drugs (2013) Using Disproportionality Analysis.
机构信息
Department of Clinical Research, Delhi Pharmaceutical Science and Research University (DPSRU), New Delhi, 110017, India.
Department of Pharmaceutics and Industrial Pharmacy, College of Pharmacy, Taif University, Taif, 21944, Kingdom of Saudi Arabia.
出版信息
Curr Drug Saf. 2024;19(3):395-401. doi: 10.2174/0115748863276447231108092936.
BACKGROUND
Drugs are related with various adverse drug reactions (ADRs), however, many unexpected ADRs of drugs are reported through post-marketing surveillance.
AIM
The current study's goal is to uncover potential signals connected with FDA-approved medications in the United States (2013).
METHODS
Open Vigil 2.1-MedDRA-v24 (data 20004Q1-2021Q3) was used as a tool to query the FAERS data. To find possible signals, disproportionality measures such as Proportional Reporting Ratio (PRR 2) with associated Chi-square value, Reporting Odds Ratio (ROR 2) with 95% confidence interval, and case count (3) were calculated.
RESULTS
A total of eight potential signals were identified with five drugs. Positive signals were found with pomalidomide, canagliflozin, dolutegravir sodium, macitentan and ibrutinib.
CONCLUSION
However, further causality assessment is required to confirm the association of these drugs with identified potential signals.
背景
药物与各种药物不良反应（ADR）有关，但许多药物的意外 ADR 通过上市后监测报告。
目的
本研究旨在发现与美国 FDA 批准的药物（2013 年）相关的潜在信号。
方法
使用开放式监测 2.1-MedDRA-v24（数据 20004Q1-2021Q3）作为工具查询 FAERS 数据。为了寻找可能的信号，使用了比例报告比值（PRR 2）与相关卡方值、报告比值（ROR 2）与 95%置信区间和病例数（3）等比例失调衡量标准来计算。
结果
总共发现了五种药物的八个潜在信号。与泊马度胺、卡格列净、多替拉韦钠、马昔腾坦和伊布替尼有关的阳性信号。
结论
然而，需要进一步的因果关系评估来确认这些药物与已识别的潜在信号之间的关联。
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