注射用头孢哌酮钠舒巴坦钠原研药与仿制药的有效性和安全性评价OA

Objective To evaluate the effectiveness and safety of the original drug and the generic drug of Cefoperazone Sodium and Sulbactam Sodium for Injection using real-world data.Methods Retrospective collection of information on inpatients at the First Affiliated Hospital of Dali University who had used the original drug(product name:Sulperazon)or generic drug(product name:Valin)of Cefoperazone sodium sulbactam sodium for injection from March 2022 to February 2023.The inpatient information was divided into Sulperazon group and Valin group according to drug varieties.The effectiveness and safety of the two groups were compared by using PSM method to balance the differences between the two groups.Results A total of 1777 patients were enrolled based on the Inclusion and exclusion criteria,with 560 in the Sulperazon group and 1217 in the Valin group.Following propensity score matching,477 patients were included in each group.The evaluation of effectiveness indicated no statistically significant differences between the two groups in clinical effectiveness rate(75.9%vs.78.2%,P=0.397),bacterial clearance rate(69.6%vs.53.1%,P=0.220),nor the reduction rate of various infection indicators(P＞0.05).C-reactive protein(CRP)and neutrophils(NEUT)were reduced to a larger extent in the Sulperazon group than in the Valin group after the application of the drug,and the differences were statistically significant(P＜0.05).The safety evaluation results displayed a comparable incidence rate of adverse events between the two groups(0.8%vs.1.3%,P=0.525),as well as similar incidence rates of liver function and blood system abnormality indicators(P＞0.05).Conclusion There was no significant difference in effectiveness between the original Cefoperazone Sodium and Sulbactam Sodium for Injection and the generic in clinical applications,and the two drugs have comparable safety.