低分子肝素用于复发性流产合并抗磷脂综合征适应症超说明书用药临床综合评价  

Clinical comprehensive evaluation for off-label medication of low molecular weight heparin in the treatment of recurrent spontaneous abortion complicated with antiphospholipid syndrome

作　　者：刘付盈 李海俏 邓文荣 李小波 Liu Fuying;Li Haiqiao;Deng Wenrong;Li Xiaobo(Department of Pharmaceutical,Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine,Zhuhai Guangdong 519020,China)

机构地区：[1]珠海市中西医结合医院药学部,广东珠海519020

出　　处：《遵义医科大学学报》2025年第4期374-379,共6页Journal of Zunyi Medical University

基　　金：珠海市社会发展领域科技计划项目(NO:2320004000099)。

摘　　要：目的建立低分子肝素(LMWH)复发性流产合并抗磷脂综合征适应症超说明书用药临床综合评价方法,并为这类患者选择合适的LMWH提供理论依据。方法运用文献调查法、德尔菲法、专家咨询法与层次分析法,建立LMWH复发性流产合并抗磷脂综合征适应症超说明书用药临床综合评价方法。并根据指标权重计算目前上市常用的4种LMWH临床综合评价得分。结果该研究构建了LMWH复发性流产合并抗磷脂综合征适应症临床综合评价指标体系,从有效性、安全性、经济性、适宜性、可及性5个维度对LMWH超说明书用药进行临床综合评价,总得分最高分为依诺肝素钠注射液,最低分为贝米肝素钠注射液。结论针对复发性流产合并抗磷脂综合征适应症的超说明书用药,依诺肝素钠注射液临床综合价值要高于其他种类的LMWH。Objective To establish a comprehensive clinical evaluation method for off-label medication of low molecular weight heparin(LMWH)in the treatment of recurrent spontaneous abortion complicated with antiphospholipid syndrome and to provide theoretical basis for appropriate LMWH for such patients.Methods Using literature review,Delphi method,expert consultation method,and analytic hierarchy process,a comprehensive clinical evaluation method for LMWH off-label medication in the treatment of recurrent spontaneous abortion complicated with antiphospholipid syndrome was established.Based on the weight of the indicators,the four commonly used LMWH were calculated by the clinical comprehensive evaluation.Results The study constructed a clinical comprehensive evaluation index system for LMWH,which evaluated the off-label medication in the treatment of recurrent spontaneous abortion complicated with antiphospholipid syndrome of LMWH from five dimensions:effectiveness,safety,economy,suitability and accessibility.The highest total score was for Enoxaparin Sodium injection,and the lowest score was for Bemiparin Sodium injection.Conclusion For the indications of recurrent spontaneous abortion complicated with antiphospholipid syndrome,the clinical comprehensive value of Enoxaparin Sodium injection is higher than that of other types of LMWH.

关 键 词：低分子肝素 超说明书用药 临床综合评价 循证医学 复发性流产合并抗磷脂综合征 

分 类 号：R714.21[医药卫生—妇产科学]