目的 以《中國(guó)醫(yī)療機(jī)構(gòu)藥品評(píng)價(jià)與遴選快速指南（第二版）》為基準(zhǔn)構(gòu)建評(píng)估體系，對(duì)注射用抗耐甲氧西林金黃色葡萄球（ MRSA）藥物開(kāi)展多維度綜合評(píng)價(jià)，旨在為臨床合理用藥及醫(yī)療機(jī)構(gòu)藥品遴選提供循證依據(jù)。方法 采用系統(tǒng)性文獻(xiàn)回顧策略，全面納入?yún)⒃u(píng)藥品的真實(shí)世界研究、Meta分析、隨機(jī)對(duì)照試驗(yàn)、臨床指南、系統(tǒng)綜述、專(zhuān)家共識(shí)及藥品說(shuō)明書(shū)等多源證據(jù)，結(jié)合治療MRSA注射劑的臨床特性，優(yōu)化評(píng)價(jià)指標(biāo)體系，并從5個(gè)維度進(jìn)行量化評(píng)估，分別為藥學(xué)特性、經(jīng)濟(jì)性、有效性、安全性及其他屬性。結(jié)果 所有納入評(píng)估的注射用MRSA治療藥物綜合評(píng)分均高于65分，其中江蘇正大豐海制藥生產(chǎn)的利奈唑胺注射液以80.0分位居首位，麗珠集團(tuán)生產(chǎn)的萬(wàn)古霉素（ 75.9分）與VIANEX S.A.生產(chǎn)的萬(wàn)古霉素（ 75.6分）分列其后。其他注射液的評(píng)分結(jié)果依次為：利奈唑胺注射液（Pfizer AS） 73.7分、奈諾沙星（浙江醫(yī)藥） 70.0分、達(dá)托霉素（安士制藥） 69.7分、替考拉寧（浙江醫(yī)藥） 68.8分、去甲萬(wàn)古霉素（華北制藥）得分最低為66.2分。納入不同生產(chǎn)企業(yè)的萬(wàn)古霉素與利奈唑胺制劑進(jìn)行評(píng)估，結(jié)果顯示國(guó)家藥品集中采購(gòu)的仿制藥（已通過(guò)一致性評(píng)價(jià)）在藥品經(jīng)濟(jì)學(xué)維度中顯著優(yōu)于原研產(chǎn)品。結(jié)論 所有納入評(píng)估的MRSA治療用注射劑均展現(xiàn)出良好的臨床應(yīng)用價(jià)值，為醫(yī)療機(jī)構(gòu)在治療MRSA抗菌藥物注射劑遴選與促進(jìn)臨床合理用藥提供數(shù)據(jù)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

秦皇島市科學(xué)技術(shù)研究與發(fā)展計(jì)劃項(xiàng)目（202301A024）