Lyu Shu-Xian, Qian Dong-Fang, Feng Yu-Fei, Shen Cheng-Wu, Guo Lu-Bo, Lyu Jian-Tao, Jin Peng-Fei, Li Ting, Tan Si-Yuan, Zhang Zi-Xuan, Huang Lin, Zhong Xue, Su Le-Qun, Hu Xin, Huang Xin, Cui Xue-Yan
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.
Beijing North Medical Health Economic Research Center, Beijing, China.
J Geriatr Cardiol. 2023 Apr 28;20(4):293-308. doi: 10.26599/1671-5411.2023.04.002.
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.
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.
81,292 patients were included in this study. After propensity score matching, the NBP, EDV, and third groups with 727 patients 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.
In a large real-world population, NBP has a lower incidence of adverse events and a better safety profile than EDV or other usual medications.
丁苯酞（NBP）和依达拉奉（EDV）注射液是中国常见的急性缺血性脑卒中用药，但缺乏关于它们的大型真实世界安全性研究。本研究旨在确定不良事件的发生率，检测相关安全信号，并评估真实世界人群中与这些药物相关的危险因素。
在本研究中，提取了2019年1月至2021年8月期间六家三级医院电子病历数据库中急性缺血性脑卒中患者的数据。使用倾向得分匹配法消除基线混杂因素。通过比较24项肝功能、肾功能、血脂水平和凝血功能实验室检测标准的结果来评估药物的安全性。通过逻辑回归估计药物的相对风险。构建第三组未接受NBP或EDV治疗的患者作为对照。分别使用处方顺序对称性分析来评估不良事件与NBP和EDV之间的关联。
本研究共纳入81292例患者。经过倾向得分匹配后，NBP组、EDV组和第三组每组各有727例患者。在15项检测项目中，NBP组不良事件的发生率低于EDV组，差异具有统计学意义。多因素逻辑回归方程显示，NBP注射液不是实验室检测结果异常的促进因素，而EDV对天冬氨酸转氨酶、低密度脂蛋白胆固醇和总胆固醇有统计学显著影响。处方顺序对称性分析表明，NBP与血小板计数异常的相关性较弱。EDV与γ-谷氨酰转移酶、丙氨酸转氨酶、天冬氨酸转氨酶、凝血酶原时间和血小板计数异常结果存在正相关信号。
在大型真实世界人群中，NBP的不良事件发生率低于EDV或其他常用药物，安全性更好。
