目的 评估复方鳖甲软肝片和恩替卡韦联合治疗慢性乙型肝炎（CHB）的成本-效果。方法 从医疗保障支付方角度出发，以复方鳖甲软肝片联用恩替卡韦治疗CHB的最新临床研究结果作为数据来源，采用Markov模型模拟评估与单用恩替卡韦相比，复方鳖甲软肝片联用恩替卡韦的成本与效用，与健康相关的生活质量在质量调整生命年（QALYs）中建模，以每获得的QALY的成本表示增量成本-效果比（ICER），并进行成本-效用分析和敏感性分析。结果 在基本病例分析中，复方鳖甲软肝片联用恩替卡韦的费用高于单用恩替卡韦（平均差值23 480.891 41元人民币），但也提高了每位患者一生中QALY（平均差值0.834 51 QALYs）。ICER等于28 137.428 83元/QALY（成本更高，但更有效），约占2023年我国人均GDP（89 400元）的31.474%，在愿意支付17 800元/QALY的情况下，复方鳖甲软肝片联用恩替卡韦可能是首选策略，同时敏感性分析结果均显示本研究结果较为稳定。结论 对于CHB患者而言，相比单独使用恩替卡韦治疗，复方鳖甲软肝片联用恩替卡韦治疗是更具有成本-效用优势的治疗方案。

Objective To assess the cost-effectiveness of Compound Biejia Rugan Tablets combined with entecavir for treatment of patients with chronic hepatitis B (CHB). Methods From a Medicare payer perspective, using the results of the most recent clinical study of Compound Biejia Rugan Tablets in combination with entecavir for the treatment of chronic hepatitis B as a source of data, Markov model simulations were used to assess the cost and utility of entecavir in combination with Compound Biejia Rugan Tablets compared with entecavir alone, and health-related quality of life was modeled in quality-adjusted life-years (QALYs) and expressed as cost per QALY gained and subjected to cost-utility analysis and sensitivity analysis. of QALYs and expressed as cost per QALY gained and subjected to cost-utility analysis and sensitivity analysis. Results In the base case analysis, entecavir in combination with Compound Biejia Rugan Tablets was more costly than entecavir alone (mean difference RMB 23 480.891 41), but it also decreased improved lifetime QALYs per patient (mean difference 0.834 51 QALYs). The incremental cost-effectiveness ratio (ICER) was equal to 28 137.428 83 RMB/QALY (more costly but more effective),which was about 31.474% of China's per capita GDP (89 400 RMB) in 2023, and entecavir in combination with compound turtle turtle soft liver tablets might be the preferred strategy in the willingness to pay 17 800 RMB/QALYs, while the results of the sensitivity analyses all showed that the more stable results in this study. Conclusion For many patients with CHB, treatment with entecavir in combination with Compound Biejia Rugan Tablets is a more cost-utility advantageous regimen compared with entecavir alone.

R975

国家自然科学基金项目（82204755）；广西中医药大学赛恩斯新医药学院科研项目（2022CX004， 2022MS008， 2022QJ001）；广西中医药大学赛恩斯新医药学院国家级大学生创新创业训练项目（202413643007）