Analysis of adverse events/reactions of drugs for atrial fibrillation
Objective To lay a foundation for the construction of evaluation criteria for adverse events/reactions of atrial fibrillation,to form a list of adverse events/reactions of drug treatment of atrial fibrillation through systematic review and package insert.Methods Clinical studies with a diagnosis of atrial fibrillation were searched from CNKI,Wanfang,SinoMed,EMBASE,PubMed and Cochrane,and the search time was from January 2015 to June 2022.Adverse events/reaction reported in clinical studies were extracted.Chinese patent medicines and western medicines for the treatment of atrial fibrillation were selected from the National Medical Insurance Catalogue,the National Essential Medicines Catalogue and the World Health Organization Essential Medicines List,and the adverse events/reactions reported were extracted through the package insert.After specification and merger,a list of adverse events/reactions were formed.Results A total of 411 clinical studies were included,47 kinds of package insert of Chinese patent medicines and western medicines were extracted,and 106 adverse events/reactions were included in the final list of adverse events/reactions after standardization and consolidation.The top two most frequently reported systems were nervous system and gastrointestinal disease,and the top five most frequently reported indicators were ischemic stroke,death,nausea,intracranial hemorrhage,and thromboembolic events.Conclusion Adverse events/reactions to drug therapy for atrial fibrillation involves multiple systems,the adverse events/reactions of nervous system and gastrointestinal disease should be paid attention to report in atrial fibrillation clinical study.Reporting standards for adverse events/reactions of cardiovascular diseases should be further established to provide a basis for clinical investigators to select and report hazard indicators.
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