国家集采左氧氟沙星氯化钠注射液仿制药疗效和安全性评价

Evaluation of Efficacy and Safety of Selected Generic Drugs of Levofloxacin and Sodium Chloride Injection in the National Centralized Procurement

目的:比较国家集中带量采购左氧氟沙星氯化钠注射液和原研药品治疗社区获得性肺炎的临床疗效与安全性。方法:回顾性收集福建省某大型三甲医院2020年10月20日至2022年10月20日诊断为CAP并使用左氧氟沙星氯化钠注射液的患者相关临床信息,采用倾向性评分匹配法调整组间差异,比较两组的有效性和安全性。结果:倾向评分匹配后,集采组纳入患者117例,原研组纳入患者117例。两组用药第七天临床治疗有效率、白细胞、中性粒细胞百分数、C反应蛋白、降钙素原、体温、给药疗程(天)比较,无统计学差异。两组用药后肝肾功能异常比较,无统计学差异。结论:国家集中带量采购左氧氟沙星氯化钠注射液与原研药品治疗CAP的效果与安全性相当。

Objective:The paper compares the clinical efficacy and safety of levofloxacin and sodium chloride injection in the national centralized procurement with that of the original drug for the treatment of community-acquired pneumonia(CAP).Methods:Clinical information related to patients diagnosed with CAP and using levofloxacin and sodium chloride injection in a large tertiary hospital of Fujian Province from October 20,2020 to October 20,2022 was retrospectively collected,and the propensity score matching method was used to adjust the differences between the groups and to compare the efficacy and safety of the two groups.Results:After propensity score matching,117 patients were included in the generic group and 117 patients were included in the original group.There was no statistically significant difference between the two groups in terms of clinical response rate,leukocytes,neutrophil percentage,C-reactive protein,calcitoninogen,body temperature,and the duration of drug administration(days)between the two groups on the seventh day of medication.There was no statistically significant difference in liver and kidney function abnormalities between the two groups after medication.Conclusion:The efficacy and safety of levofloxacin and sodium chloride injection national centralized procurement is equivalent to that of the original drug for the treatment of CAP.