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基于OpenFDA数据库挖掘与评价达托霉素上市后的不良反应
Mining and Evaluation of Adverse Reactions of Daptomycin After Marketing Based on OpenFDA Database
【摘要】 目的 促进达托霉素的临床合理用药。方法 采用计算机检索美国食品药物管理局公共数据开放项目(OpenFDA)数据库中有关达托霉素的不良反应报告,检索时限为2004年1月1日至2021年10月31日,提取并分析相关数据。结果 共检索到达托霉素相关不良反应报告4 301份,其中由卫生医学专员上报的3 667份(85.26%),美国报告2 263份(52.62%),适应证为葡萄球菌感染459份(31.35%),转归情况为已恢复/已解决1 197份(45.27%),报告严重不良反应5 446例次。不良反应类型主要表现为发热(350份)、寒战(277份)、血清肌酸激酶升高(268份)、急性肾功能损伤(263份)、嗜酸性粒细胞性肺炎(205份)、横纹肌溶解(202份)等,涉及肌肉骨骼系统、呼吸系统、免疫系统等。结论 基于OpenFDA数据库能多方面、多角度、深度挖掘达托霉素导致的不良反应,可为其临床安全、合理用药提供参考。
【Abstract】 Objective To promote the clinical rational drug use of daptomycin.MethodsThe adverse reaction reports of daptomycin in the U. S. Food and Drug Administration Public Data Open Project(OpenFDA) database from January 1,2004 to October 31,2021 were searched to extract and analyze the relevant data.ResultsA total of 4 301 related adverse reaction reports of daptomycin were searched,including 3 667(85. 26%) reported by the health medical commissioner,2 263(52. 62%) reported by the U. S.,459(31. 35%)indication for Staphylococcus aureus infection,1 197(45. 27%) recovered or resolved,and 5 446 case-times of serious adverse reactions reported. The main types of adverse reactions were fever(350),chills(277),elevated serum creatine kinase(268),acute renal injury(263),eosinophilic pneumonia(205),rhabdomyolysis(202) and so on,involving musculoskeletal system,respiratory system,immune system and so on.ConclusionBased on the OpenFDA database,the adverse reactions caused by daptomycin can be deeply mined from multiple aspects and angles,which can provide a reference for its clinical safety and rational drug use.
【Key words】 daptomycin; the U.S.Food and Drug Administration Public Data Open Project; adverse drug reaction; data mining;
- 【文献出处】 中国药业 ,China Pharmaceuticals , 编辑部邮箱 ,2022年07期
- 【分类号】R969
- 【下载频次】186