阿哌沙班集中带量采购中选仿制药与原研药的临床疗效和安全性研究

Clinical Efficacy and Safety of Generic and Original Drugs in Centralized Drug Volume-Based Procurement of Apixaban

目的:评价集中带量采购后阿哌沙班仿制药与原研药的临床疗效和安全性的差异,为国产仿制药上市后再评价提供真实世界的临床研究证据,也为临床医师和相关专业人员的用药选择提供证据支撑。方法:开展基于比较效果研究理念的多中心、大样本、真实世界的回顾性队列研究。选取2019年1月1日至2022年4月1日皖南医学院第一附属医院、广东省人民医院、河南省人民医院和西安交通大学附属第一医院信息系统数据库中使用阿哌沙班治疗的行髋关节或膝关节置换术或术后的成年患者临床数据。根据具体用药情况,将患者分为原研药组295例、仿制药1组641例和仿制药2组50例。比较两组患者的凝血酶原时间、国际标准化比值、活化部分凝血活酶时间和静脉血栓栓塞事件(VTE)发生率等相关疗效差异,天冬氨酸转氨酶(AST)、丙氨酸转氨酶(ALT)、尿素、血尿酸和肌酐水平等安全性差异。结果:(1)疗效方面,治疗后,三组患者凝血酶原时间、国际标准化比值、活化部分凝血活酶时间和VTE发生率的差异均无统计学意义(P>0.05)。(2)安全性方面,治疗后,三组患者AST、ALT、尿素、血尿酸和肌酐水平,以及相关不良反应发生率的差异均无统计学意义(P>0.05)。结论:集中带量采购后阿哌沙班仿制药与原研药在疗效和安全性方面相当。

OBJECTIVE:To evaluate the differences of clinical efficacy and safety between generic and original apixaban after centralized drug volume-based procurement,so as to provide real-world clinical research evidence for the re-evaluation of domestic generic drugs after marketing,and provide supporting evidence for clinicians and related professionals in drug selection.METHODS:This study was a multicenter,large-sample,real-world retrospective cohort study based on the concept of comparative effect research.Clinical data of adult patients underwent hip or knee replacement or post-operation treated with apixaban were extracted from the information system database of the First Affiliated Hospital of Wannan Medical College,/Yijishan Hospital of Wannan Medical College,Guangdong Provincial People’s Hospital,Henan Provincial People’s Hospital and the First Affiliated Hospital of Xi’an Jiaotong University from Jan.1st 2019 to Apr.1st 2022.Patients were divided into 295 cases in original drug group,641 cases in generic drug group 1(State Food and Drug Administration approval number H20193003)and 50 cases in generic drug group 2(State Food and Drug Administration approval number H20203340)according to the specific medication.Differences in efficacy related to prothrombin time,international normalized ratio,activated partial thromboplastin time and incidence of venous thromboembolic events(VTE),and differences in safety related to aspartate transaminase(AST),alanine aminotransferase(ALT),urea,blood uric acid and creatinine were compared between two groups.RESULTS:(1)In terms of efficacy,after treatment,differences in prothrombin time,international normalized ratio,activated partial thromboplastin time and VTE incidence among three groups were not statistically significant(P>0.05).(2)In terms of safety,after treatment,differences in the levels of AST,ALT,urea,blood uric acid and creatinine as well as the incidence of related adverse events among three groups were not statistically significant(P>0.05).CONCLUSIONS:Generic apixaban is comparable to the original drug in terms of efficacy and safety after centralized drug volume-based procurement.