目的 以《中国医疗机构药品评价与遴选快速指南（第二版）》为基准构建评估体系，对注射用抗耐甲氧西林金黄色葡萄球（ MRSA）药物开展多维度综合评价，旨在为临床合理用药及医疗机构药品遴选提供循证依据。方法 采用系统性文献回顾策略，全面纳入参评药品的真实世界研究、Meta分析、随机对照试验、临床指南、系统综述、专家共识及药品说明书等多源证据，结合治疗MRSA注射剂的临床特性，优化评价指标体系，并从5个维度进行量化评估，分别为药学特性、经济性、有效性、安全性及其他属性。结果 所有纳入评估的注射用MRSA治疗药物综合评分均高于65分，其中江苏正大丰海制药生产的利奈唑胺注射液以80.0分位居首位，丽珠集团生产的万古霉素（ 75.9分）与VIANEX S.A.生产的万古霉素（ 75.6分）分列其后。其他注射液的评分结果依次为：利奈唑胺注射液（Pfizer AS） 73.7分、奈诺沙星（浙江医药） 70.0分、达托霉素（安士制药） 69.7分、替考拉宁（浙江医药） 68.8分、去甲万古霉素（华北制药）得分最低为66.2分。纳入不同生产企业的万古霉素与利奈唑胺制剂进行评估，结果显示国家药品集中采购的仿制药（已通过一致性评价）在药品经济学维度中显著优于原研产品。结论 所有纳入评估的MRSA治疗用注射剂均展现出良好的临床应用价值，为医疗机构在治疗MRSA抗菌药物注射剂遴选与促进临床合理用药提供数据支持。

Objective According to the “A Quick Guidelines for Drug Evaluation and Selection in Chinese Medical Institutions (Second Edition)”, an evaluation system was developed to perform a comprehensive, multi-dimensional assessment of methicillin-resistant Staphylococcus aureus (MRSA) injectable drugs, providing evidence-based support for rational drug use and selection in medical settings. Methods A systematic literature review strategy was adopted to fully incorporate multiple sources of evidence including realworld studies, Meta-analyses, randomized controlled trials, clinical guidelines, systematic reviews, expert consensus and drug labels of participating drugs, and optimize the evaluation index system based on the clinical characteristics of MRSA injections. The quantitative evaluation was carried out from five dimensions, namely pharmaceutical properties, economy, effectiveness, safety and other attributes. Results The comprehensive scores of all MRSA injectable drugs included in the evaluation were higher than 65 points, among which Linezolid injection produced by Jiangsu Zhengda Fenghai Pharmaceutical ranked first with 80.0 points, vancomycin produced by Lizon Group (75.9 points) and VIANEX S.A. Vancomycin production (75.6 points) was next. The scores of other injections were AS follows: Linezolid injection (Pfizer AS) scored 73.7 points, Neofloxacin (Zhejiang Pharmaceutical) scored 70.0 points, Dattomycin (ASZ Pharmaceutical) scored 69.7 points, Teicolanin (Zhejiang Pharmaceutical) scored 68.8 points, and norvancomycin (Huabei Pharmaceutical) scored the lowest 66.2 points. In this study, vancomycin and linezolid preparations from different manufacturers were included for evaluation, and the results showed that generic drugs (which had passed the consistency evaluation) of national centralized drug procurement were significantly better than original products and reference systems in the dimension of pharmacoeconomics. Conclusion All the MRSA therapeutic injections included in the evaluation showed good clinical application value, providing data support for medical institutions in the treatment of MRSA antimicrobial injection selection and promotion of clinical rational drug use.

R978.1

秦皇岛市科学技术研究与发展计划项目（202301A024）