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4301份,其中由卫生医学专员上报的3667份(85.26%),美国报告2263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1197份(45.27%),报告严重不良反应5446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。
Objective To promote the clinical rational drug use of daptomycin.Methods The 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.Results A total of 4301 related adverse reaction reports of daptomycin were searched,including 3667(85.26%)reported by the health medical commissioner,2263(52.62%)reported by the U.S.,459(31.35%)indication for Staphylococcus aureus infection,1197(45.27%)recovered or resolved,and 5446 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.Conclusion Based 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.
作者
展敬伦
石健
柴双
刘晓东
ZHAN Jinglun;SHI Jian;CHAI Shuang;LIU Xiaodong(Department of Pharmacy,Shengjing Hospital of China Medical University,Shenyang,Liaoning,China 110004;Department of The Second Clinical Pharmacy,School of Pharmacy,China Medical University,Shenyang,Liaoning,China 110001)
出处
《中国药业》
CAS
2022年第7期109-111,共3页
China Pharmaceuticals
基金
中国医科大学附属盛京医院2020年40工程[M0723]。
