非口服抗凝药物应用于妊娠期和产褥期静脉血栓栓塞疾病的临床综合评价体系的建立

Comprehensive clinical assessment of parenteral anticoagulants for venous thromboembolism during pregnancy and puerperium

目的对非口服抗凝药物在妊娠期和产褥期静脉血栓栓塞疾病中的应用进行临床综合评价,为临床合理使用非口服抗凝药物提供科学依据。方法采用德尔菲法和层次分析法对非口服抗凝药物的安全性、有效性、经济性、适宜性、创新性和可及性6个维度进行评价指标筛选,以及循证证据收集和分析,构建非口服抗凝药物应用于妊娠期和产褥期静脉血栓栓塞疾病的临床综合评价体系,包括6个一级指标、22个二级指标,对低分子肝素钙/钠、依诺肝素、那屈肝素、贝米肝素、达肝素和磺达肝癸进行临床综合评价。结果6个一级指标和22个二级指标的循证证据来源于系统评价(Meta分析)、药品说明书、临床指南和专家共识等。根据建立的非口服抗凝药物应用于妊娠期和产褥期静脉血栓栓塞疾病的临床综合评价体系对非口服抗凝药物进行评价,结果显示,在6种药物中,总分最高为那屈肝素,最低为贝米肝素。其中安全性得分最高的是磺达肝癸,有效性得分最高的是低分子肝素钙/钠和依诺肝素,适宜性得分最高的是磺达肝癸,可及性得分最高的是依诺肝素,创新性得分最高的是磺达肝癸,经济性得分最高的是低分子肝素钙/钠。结论不同非口服抗凝药物在妊娠期和产褥期静脉血栓栓塞疾病的治疗中具有不同的优势,通过临床综合评价对药品进行量化评分可为临床合理用药提供参考。

AIM To conduct a clinical comprehensive evaluation of parenteral anticoagulants in the management of venous thromboembolism during pregnancy and puerperium,providing a scientifically robust basis to guide the prudent use of these agents in clinical practice.METHODS The clinical utility of parenteral anticoagulants was evaluated,utilizing the Delphi method in conjunction with the Analytic Hierarchy Process(AHP).Clinical evaluation indicators were meticulously selected across 6 key dimensions:safety,efficacy,cost-effectiveness,appropriateness,innovation,and accessibility.Evidence-based evidence was collected and analyzed to construct a clinical comprehensive evaluation system for the application of parenteral anticoagulants in venous thromboembolism during pregnancy and puerperium.The system comprised 6 first-level indicators and 22 second-level indicators.The clinical comprehensive evaluation was conducted on low-molecular-weight heparin calcium/sodium,enoxaparin,nadroparin,bemiparin,dalteparin,and fondaparinux.RESULTS The evidence-based evidence for the 6 first-level indicators and 22 second-level indicators derived from systematic reviews(Meta-analysis),medicine instructions,clinical practice guidelines,and expert consensus,etc.According to the established clinical comprehensive evaluation system for the application of parenteral anticoagulants in venous thromboembolism disease during pregnancy and puerperium,various low-molecular-weight heparin agents were evaluated.The results revealed that nadroparin achieved the highest overall score in the evaluation,followed by enoxaparin,with bemiparin scoring the lowest.Specifically,fondaparinux had the highest safety and appropriateness scores,low-molecular-weight heparin and enoxaparin scored highest for effectiveness,enoxaparin for accessibility,and fondaparinux for innovation,with low molecular weight heparin leading in economy.CONCLUSION Various parenteral anticoagulants exhibit distinct advantages in treating venous thromboembolism during pregnancy and puerperium.A comprehensive clinical evaluation of parenteral anticoagulants used for the management of venous thromboembolic disease during pregnancy and the puerperium is conducted,aiming to provide a scientific basis for the rational use of parenteral anticoagulants in clinical practice.