Safety of butylphthalide and edaravone in patients with ischemic stroke:a multicenter real-world study  

作　　者：Shu-Xian LYU Dong-Fang QIAN Yu-Fei FENG Cheng-Wu SHEN Lu-Bo GUO Jian-Tao LYU Peng-Fei JIN Ting LI Si-Yuan TAN Zi-Xuan ZHANG Lin HUANG Xue ZHONG Le-Qun SU Xin HU Xin HUANG Xue-Yan CUI 

机构地区：[1]Department of Clinical Pharmacy,the First Affiliated Hospital of Shandong First Medical University&Shandong Provincial Qianfoshan Hospital,Shandong Medicine and Health Key Laboratory of Clinical Pharmacy,Shandong,China [2]Beijing North Medical Health Economic Research Center,Beijing,China [3]Department of Pharmacy,Peking University People’s Hospital,Beijing,China [4]Department of Pharmacy,Shandong Provincial Hospital Affiliated to Shandong First Medical University,Shandong,China [5]Department of Pharmacy,Central Hospital Affiliated to Shandong First Medical University,Shandong,China [6]Department of Pharmacy,Yantai Affiliated Hospital of Binzhou Medical University(the Second School of Clinical Medicine of Binzhou Medical University),Shandong,China [7]Department of Pharmacy,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application(Beijing Hospital),Beijing,China

出　　处：《Journal of Geriatric Cardiology》2023年第4期293-308,共16页老年心脏病学杂志（英文版）

基　　金：supported by the China Society for Drug Regulation(CSDR)Project:exploration of criteria for post-marketing risk assessment of medications using real-world data(DRM2021008);the Special Clinical Pharmacy Program of Shandong Medical Association(YXH2022ZX004)。

摘　　要：BACKGROUND Butylphthalide(NBP)and edaravone(EDV)injection are common acute ischemic stroke medications in China,but there is a lack of large real-world safety studies on them.This study aimed to determine the incidence of adverse events,detect relevant safety signals,and assess the risk factors associated with these medications in real-world populations.METHODS In this study,data of acute ischemic stroke patients were extracted from the electronic medical record database of six tertiary hospitals between January 2019 and August 2021.Baseline confounders were eliminated using propensity score matching.The drugs’safety was estimated by comparing the results of 24 laboratory tests standards on liver function,kidney function,lipid level,and coagulation function.The drugs’relative risk was estimated by logistic regression.A third group with patients who did not receive NBP or EDV was constructed as a reference.Prescription sequence symmetry analysis was used to evaluate the associations between adverse events and NBP and EDV,respectively.RESULTS 81,292 patients were included in this study.After propensity score matching,the NBP,EDV,and third groups with 727patients in each group.Among the 15 test items,the incidence of adverse events was lower in the NBP group than in the EDV group,and the differences were statistically significant.The multivariate logistic regression equation revealed that NBP injection was not a promoting factor for abnormal laboratory test results,whereas EDV had statistically significant effects on aspartate transaminase,low-density lipoprotein cholesterol and total cholesterol.Prescription sequence symmetry analysis showed that NBP had a weak correlation with abnormal platelet count.EDV had a positive signal associated with abnormal results in gamma-glutamyl transferase,alanine aminotransferase,aspartate aminotransferase,prothrombin time,and platelet count.CONCLUSIONS In a large real-world population,NBP has a lower incidence of adverse events and a better safety profile than EDV or other usu

关 键 词：PATIENTS DRUGS injection 

分 类 号：R743.3[医药卫生—神经病学与精神病学]