[关键词]
[摘要]
目的 构建适用于天津市中心妇产科医院的注射用抗凝药物临床综合评价模型,为药品准入决策与临床合理用药提供工具支持。方法 以《中国医疗机构药品评价与遴选快速指南(第三版)》为基础框架,通过多学科团队协作,结合妇产科临床需求对指标体系进行专科化重构。采用改良德尔菲法及专家直接赋权法确定各维度权重与评分规则,并对天津市中心妇产科医院在用的6种注射用抗凝剂(依诺肝素钠、达肝素钠、那屈肝素钙、贝米肝素、低分子肝素钠、磺达肝癸钠)进行实证评价。结果 18名专家完成函询(有效回收率100%),专家权威系数(Cr)=0.82,一级指标重要性评分的Kendall’s W=0.608(P<0.001)。模型将安全性权重提升至30.18%、经济性权重提升至13.00%,较《中国医疗机构药品评价与遴选快速指南(第3版)》分别上调3.18%和3.00%。实证评价显示,磺达肝癸钠(76.05分)、贝米肝素(73.01分)和依诺肝素钠(72.18分)综合得分居前。结合核心安全性指标,6种药物归入3类临床场景:常规预防、孕期长期维持、血小板减少症/过敏替代。结论 模型在通用评价框架基础上实现了专科化改良,可为妇产科医院的抗凝药物遴选与管理提供参考。
[Key word]
[Abstract]
Objective To construct a comprehensive clinical evaluation model for anticoagulant drugs for injection tailored to Tianjin Central Hospital of Obstetrics Gynecology, and to provide a tool for drug access decisions and rational clinical use. Methods Based on the Rapid Guideline for Drug Evaluation and Selection in Chinese Medical Institutions (Third Edition), the indicator framework was restructured through multidisciplinary team collaboration to address specialty-specific clinical needs in obstetrics and gynecology. A modified Delphi method and direct expert weighting were used to determine dimension weights and scoring rules. Empirical evaluation was conducted on six injectable anticoagulants used in Tianjin Central Hospital of Obstetrics Gynecology (enoxaparin sodium, dalteparin sodium, nadroparin calcium, bemiparin, low-molecular-weight heparin sodium, and fondaparinux). Results Eighteen experts completed the consultation (response rate: 100%). The expert authority coefficient (Cr) was 0.82, and Kendall’s W for the importance of first-level indicators was 0.608 (P< 0.001). The model increased the weight of safety to 30.18% and that of economy to 13.00%, representing increases of 3.18 and 3.00 percentage points, respectively, over the Rapid Guideline for Drug Evaluation and Selection in Chinese Medical Institutions (Third Edition). Empirical evaluation showed that fondaparinux (76.05), bemiparin (73.01), and enoxaparin sodium (72.18) ranked highest in composite scores. Combined with core safety indicators, the six drugs were classified into three clinical scenarios: routine prophylaxis, long-term maintenance during pregnancy, and HIT/allergy alternatives. Conclusion The model represents a specialty-specific adaptation of the general evaluation framework and may serve as a reference tool for anticoagulant selection and management in Tianjin Central Hospital of Obstetrics Gynecology.
[中图分类号]
R984
[基金项目]
天津市医院协会医院管理研究项目(2025zc60)