摘要
目的比较集采中选仿制与原研利奈唑胺葡萄糖注射液治疗细菌感染的临床疗效,为国家组织集采中选利奈唑胺葡萄糖注射液的临床使用及效果评价提供真实世界证据。方法回顾性收集首都医科大学宣武医院在2019年1月—2023年6月期间使用集采中选仿制或原研利奈唑胺葡萄糖注射液治疗成人细菌感染患者的诊疗资料。采用1:1倾向性评分匹配法平衡了组间人口统计学特征、合并症、感染类型及其严重程度、合并用药和治疗等关键指标。对集采中选仿制组和原研组患者的住院期间生存情况、28 d感染治疗成功率、3 d体温恢复率、换药率、住院时间以及治疗后体温和实验室检查指标的变化进行了比较分析。结果共纳入485例使用集采中选仿制或原研利奈唑胺葡萄糖注射液的患者,1:1匹配后每组各155例。集采中选仿制组较原研组住院死亡风险比(HR0.848,95%CI:0.51~1.40,P=0.530)及住院全因死亡率(18.7%vs 21.3%,P=0.670)均未达到统计显著性。在28 d感染治疗成功率(72.9%vs 63.9%)、3 d体温恢复率(88.2%vs 82.9%)、换药率(8.4%vs 12.9%)以及平均住院时间(27.76 d vs 29.61 d)方面,组间差异均无统计显著性(P>0.05)。利奈唑胺葡萄糖注射液治疗后体温和实验室检查值分布相似,组间差异不具有临床意义。结论集采中选仿制利奈唑胺葡萄糖注射液与原研药在治疗成人细菌感染方面临床疗效相当。
Objective To compare the clinical efficacy of the generic and original linezolid glucose injections selected through national procurement for treating bacterial infections and provide real-world evidence for the clinical use and evaluation of the selected linezolid glucose injection.Methods A retrospective collection of medical data was conducted for adult patients with bacterial infections treated with either the generic or original linezolid glucose injections at Xuanwu Hospital of Capital Medical University from January 2019 to June 2023.A 1:1 propensity score matching method was used to balance key demographic characteristics,comorbidities,infection types and severity,concomitant medications,and treatment between the two groups.Comparative analysis was performed on inpatient survival,28-day infection treatment success rate,3-day fever recovery rate,medication change rate,hospital stay duration,and changes in body temperature and laboratory test results post-treatment between the generic and original drug groups.Results A total of 485 patients treated with either the generic or original linezolid glucose injections were included,with 155 cases in each group after 1:1 matching.There were no statistically significant differences between the generic and original drug groups in terms of inpatient mortality risk(HR0.848,95%CI:0.51~1.40,P=0.530),all-cause inpatient mortality rate(18.7%vs.21.3%,P=0.670),28-day infection treatment success rate(72.9%vs.63.9%,P=0.112),3-day fever recovery rate(88.2%vs.82.9%,P=0.459),medication change rate(8.4%vs.12.9%,P=0.269),or average hospital stay(27.76 days vs.29.61 days,P=0.400).Body temperature and laboratory test values were similar after linezolid glucose injection treatment,with no clinically significant differences between the groups.Conclusion The generic linezolid glucose injection selected through national procurement showed comparable clinical efficacy to the original drug in treating adult bacterial infections.
作者
王之舟
王可
邢晓璇
花一鸣
张晓彤
李晓曦
冯英楠
董宪喆
张兰
WANG Zhizhou;WANG Ke;XING Xiaoxuan;HUA Yiming;ZHANG Xiaotong;LI Xiaoxi;FENG Yingnan;DONG Xianzhe;ZHANG Lan(Department of Pharmacy,Xuanwu Hospital,Capital Medical University,Beijing 100053)
出处
《中国抗生素杂志》
2026年第2期227-234,共8页
Chinese Journal of Antibiotics
基金
国家医疗保障局委托项目(No.JCS-ZCHT-2023-002)
吴阶平医学基金会临床科研专项资助基金(No.320.6750.2023-06-72)。
关键词
国家集中带量采购
利奈唑胺
仿制药
原研药
疗效
抗菌药物
National centralized drug procurement
Linezolid
Generic drug
Original drug
Efficacy
Antibacterial agents
