【摘要】 目的 构建直接口服抗凝药（DOACs）用于肿瘤相关静脉血栓栓塞（CAVTE）预防的临床综合评价体系，为CAVTE的合理防治、抗凝药物宏观管理策略的制定及调整提供支持和参考。方法 通过文献检索，收集整理评价指标，初步建立指标池；以指标重要性评分均值≥3.5及变异系数（CV）<0.25为筛选指标，通过两轮德尔菲法开展评价指标遴选，采用层次分析法（AHP）最终明确指标权重。结果 两轮专家咨询的权威程度（Cr）分别为0.877、0.943,CV分别为0.24、0.18,Kendall协调系数分别为0.331、0.535(P<0.05)。经两轮专家咨询论证，最终将6个一级指标及46个二级指标纳入评价体系。一级指标及权重排序依次为“有效性”（38.86%）、“安全性”（38.86%）、“经济性”（10.67%）、“可及性”（5.51%）、“适宜性”（3.48%）、“创新性”（2.64%）。二级指标组合权重范围为0.02%～20.25%，排前5位的依次为“颅内大出血发生率”（20.25%）、“全因死亡风险的降低”（15.29%）、“肺栓塞发生率的降低”（8.82%）、“深静脉血栓发生率的降低”（7.25%）和“药物使用禁忌证”（4.74%）。结论 本研究建立了权威、科学、可靠的DOACs用于CAVTE预防的药品临床综合评价体系。更多还原

【Abstract】 OBJECTIVE To establish a clinical comprehensive evaluation framework for direct oral anticoagulants(DOACs) in the prevention of cancer-associated venous thromboembolism(CAVTE), providing a methodological reference for the rational prevention and treatment of CAVTE as well as for the formulation and adjustment of macro-management strategies for anticoagulant drugs. METHODS Through literature retrieval, evaluation indicators were collected and organized to establish a preliminary indicator pool. The selection of evaluation indicators was carried out through two rounds of Delphi surveys using average score of indicator importance≥3.5 and a coefficient of variation(CV) <0.25 as the screening criteria. Analytic hierarchy process(AHP) was employed to finalize the indicator weights. RESULTS The authority levels(Cr) of the two rounds of expert consultations were 0.877 and 0.943, with CV of 0.24 and 0.18, respectively. The Kendall concordance coefficients were 0.331 and 0.535(P<0.05).After expert validation, six primary indicators and forty-six secondary indicators were finalized for inclusion in the evaluation framework. The primary indicators and their weightings, ranked in descending order, were as follows: “effectiveness”(38.86%), “safety”(38.86%), “cost-effectiveness”(10.67%), “accessibility”(5.51%), “suitability”(3.48%), and “innovation”(2.64%).The secondary indicators exhibited a weight range from 0.02% to 20.25%, with the top five secondary indicators being: “incidence of intracranial hemorrhage”(20.25%), “reduction in all-cause mortality”(15.29%), “decrease in the incidence of pulmonary embolism”(8.82%), “reduction in the incidence of deep vein thrombosis”(7.25%), and “drug contraindications”(4.74%). CONCLUSIONS This study has established an authoritative, scientific, and reliable comprehensive clinical evaluation framework for the use of DOACs in the prevention of CAVTE.更多还原