关键词: FAERS database Scars Signal mining Valaciclovir acyclovir

Mesh : Humans Acyclovir / adverse effects Valacyclovir / adverse effects Cicatrix / chemically induced Bayes Theorem Valine / adverse effects Antiviral Agents / adverse effects

来  源:   DOI:10.1080/17512433.2023.2294002

Abstract:
UNASSIGNED: This study aimed to explore a comprehensive empirical investigation and assess SCARs related to valaciclovir or acyclovir based on FAERS database from FDA, thus providing a theoretical foundation for the rational application of drugs in clinic.
UNASSIGNED: SCARs reports relevant to valaciclovir or acyclovir were searched in FAERS database from the 2004 Q1 to 2023 Q2. These data were further mined by a proportional analysis and Bayesian approach to detect signals of SCARs caused by two drugs. Meanwhile, the clinical characteristics, onset time, correlation, and stratification analysis of the two drugs in SCARs were analyzed.
UNASSIGNED: Both drugs exhibited positive signals for drug reaction with DRESS, AGEP, TEN, SJS-TEN overlap and SJS. The median onset time of SCARs caused by valaciclovir or acyclovir was 30 days vs 10 day for DRESS, 11 days vs 9 days for AGEP, 17 days vs 12 days (TEN) and 12 days vs 8 days (SJS). Excluding the effect of combinational drugs, there was an association between the two antiviral drugs and SCARs.
UNASSIGNED: By analyzing the FAERS database, the risk trends of SCARs caused by valaciclovir or acyclovir have been identified, providing valuable insights to recognize various types of SCARs in clinics.
摘要:
本研究旨在探索全面的实证调查,并根据FDA的FAERS数据库评估与伐昔洛韦或阿昔洛韦相关的SCAR,从而为临床合理用药提供理论依据。
在2004年第一季度至2023年第二季度的FAERS数据库中搜索了与伐昔洛韦或阿昔洛韦相关的SCAR报告。通过比例分析和贝叶斯方法进一步挖掘这些数据,以检测两种药物引起的SCAR信号。同时,临床特征,发病时间,相关性,并对两种药物在SCAR中的分层分析。
两种药物均表现出与DRESS药物反应的阳性信号,AGEP,十,SJS-TEN重叠和SJS。伐昔洛韦或阿昔洛韦引起的SCAR的中位起效时间为30天,而DRESS为10天,AGEP为11天vs9天,17天vs12天(TEN)和12天vs8天(SJS)。排除联合药物的作用,两种抗病毒药物与SCAR之间存在关联.
通过分析FAERS数据库,已经确定了伐昔洛韦或阿昔洛韦引起的SCAR的风险趋势,提供有价值的见解,以识别诊所中的各种类型的SCAR。
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