目的 在中国的医疗环境下评估蛭蛇通络胶囊与脑安胶囊治疗中风（气虚血瘀证）恢复期患者的经济性。方法 基于蛭蛇通络胶囊治疗中风病（气虚血瘀证）的III期临床试验和已发表的临床研究数据，从医保角度出发，构建Markov模型模拟III期临床试验结束后蛭蛇通络胶囊与脑安胶囊治疗中风（气虚血瘀证）患者的疾病进展情况，评价2种治疗方案的经济性。结果 模型结果显示，在模拟长期（30年）的治疗中，蛭蛇通络胶囊平均治疗成本为130 193.70元，质量调整生命年（quality adjusted life year，QALY）为6.62年；脑安胶囊平均治疗成本为130 204.41元，QALY为6.52年。与脑安胶囊相比，蛭蛇通络胶囊可节约10.71元，可多获得0.10个QALY，增量成本-效果比（incremental cost effectiveness ratio，ICER）为-102.52元/QALY。结论 与脑安胶囊相比，蛭蛇通络胶囊治疗中风（气虚血瘀证）的长期成本较低、产出略高，具有一定的药物经济学优势。

Objective To evaluate the economic efficiency of Zhishe Tongluo Capsule (蛭蛇通络胶囊) and Naoan Capsule (脑安胶囊) in the treatment of convalescent patients with apoplexy (qi deficiency and blood stasis syndrome) in China. Methods Based on the phase III clinical trial and published clinical research data of Zhishe Tongluo Capsule, the study was carried out from the perspective of medical insurance. Markov model was used to simulate the disease progression and economic efficiency of Zhishe Tongluo Capsule and Naoan Capsule in the treatment of apoplexy patients after the end of phase III clinical trial. Results The model results showed that the average treatment cost of Zhishe Tongluo Capsule was 130 193.70 RMB with quality adjusted life year (QALY) of 6.62 years, and the average treatment cost of Naoan Capsule was 130 204.41 RMB with QALY of 6.52 years in the simulated long-term (30 years) treatment. Compared with Naoan Capsule, Zhishe Tongluo Capsule can save 10.71 RMB and gain 0.10 more QALY. The incremental cost effectiveness ratio (ICER) was -102.52 RMB/QALY. Conclusion Compared with Naoan Capsule, Zhishe Tongluo Capsule has lower long-term cost and slightly higher output for the treatment of apoplexy (qi deficiency and blood stasis syndrome), which has some pharmacoeconomic advantages.

R285.63

中央高校基本科研业务专项（2020-JYB-ZDGG-072）