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.

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, 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 and 50 cases in generic drug group 2 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. [ABSTRACT FROM AUTHOR]