国产和原研利奈唑胺葡萄糖注射液治疗葡萄球菌和肠球菌轻中度血流感染疗效及安全性比较

Comparison of Efficacy and Safety Between Domestic and Original-Patented Linezolid and Glucose Injection in the Treatment of Staphylococcal and Enterococcal Mild-to-Moderate Bloodstream Infections

目的探讨国产和原研利奈唑胺葡萄糖注射液治疗葡萄球菌和肠球菌血流感染的临床疗效和安全性。方法回顾性选取2020年1月至2022年4月住院并分别使用国产和原研利奈唑胺葡萄糖注射液的患者,采用倾向性评分法匹配为暴露组和非暴露组,各30例。比较两组的主要疗效指标(30 d全因死亡率、住院死亡率),次要结局指标(菌血症持续时间、住院时间)及药品不良反应发生率。并根据细菌类别、疾病严重程度、用药原因等因素对30 d全因死亡率进行亚组分析。结果两组患者的30 d全因死亡率、住院死亡率、菌血症持续时间、药品不良反应发生率均无显著差异(P>0.05)。暴露组患者的住院时间显著长于非暴露组(P<0.05)。不同年龄、感染来源、细菌类别、用药原因、急性生理学和慢性健康状况评价Ⅱ(APACHEⅡ)量表评分(0~20分)亚组患者30 d全因死亡率无显著差异(P>0.05)。结论对于轻中度葡萄球菌或肠球菌血流感染患者,国产与原研利奈唑胺葡萄糖注射液的临床疗效和安全性基本相当。

Objective To investigate the clinical efficacy and safety of domestic and original-patented Linezolid and Glucose Injection in the treatment of Staphylococcal and Enterococcal bloodstream infections.Methods Patients treated with domestic and original-patented Linezolid and Glucose Injection in the hospital from November 2021 to April 2022 were selected retrospectively.The patients were divided into the exposure group and the non-exposure group by the propensity score-matched method,with 30 cases in each group.The main efficacy indicators(30-day all-cause mortality,in-hospital mortality),secondary outcome indicators(bacteremia duration,hospital stay),and the incidence of adverse drug reactions were compared between the two groups.A subgroup analysis of the 30-day all-cause mortality rate was conducted based on factors such as bacterial types,disease severity,and medication reasons.Results There were no significant differences in the 30-day all-cause mortality,in-hospital mortality,bacteremia duration,or incidence of adverse drug reactions between the two groups(P>0.05).The hospital stay of patients in the exposed group was significantly longer than that in the non-exposed group(P<0.05).There was no significant difference in 30-day all-cause mortality among patients with different ages,sources of infection,bacterial types,medication reasons,acute physiology and chronic health evaluationⅡ(APACHEⅡ)scores of 0-20 points in subgroups(P>0.05).Conclusion For patients with mild-to-moderate Staphylococcal or Enterococcal bloodstream infections,the clinical efficacy and safety of domestic Linezolid and Glucose Injection are similar to those of the original-patented drug.