目的 評估復方鱉甲軟肝片和恩替卡韋聯(lián)合治療慢性乙型肝炎（CHB）的成本-效果。方法 從醫(yī)療保障支付方角度出發(fā)，以復方鱉甲軟肝片聯(lián)用恩替卡韋治療CHB的最新臨床研究結(jié)果作為數(shù)據(jù)來源，采用Markov模型模擬評估與單用恩替卡韋相比，復方鱉甲軟肝片聯(lián)用恩替卡韋的成本與效用，與健康相關(guān)的生活質(zhì)量在質(zhì)量調(diào)整生命年（QALYs）中建模，以每獲得的QALY的成本表示增量成本-效果比（ICER），并進行成本-效用分析和敏感性分析。結(jié)果 在基本病例分析中，復方鱉甲軟肝片聯(lián)用恩替卡韋的費用高于單用恩替卡韋（平均差值23 480.891 41元人民幣），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），約占2023年我國人均GDP（89 400元）的31.474%，在愿意支付17 800元/QALY的情況下，復方鱉甲軟肝片聯(lián)用恩替卡韋可能是首選策略，同時敏感性分析結(jié)果均顯示本研究結(jié)果較為穩(wěn)定。結(jié)論 對于CHB患者而言，相比單獨使用恩替卡韋治療，復方鱉甲軟肝片聯(lián)用恩替卡韋治療是更具有成本-效用優(yōu)勢的治療方案。

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

國家自然科學基金項目（82204755）；廣西中醫(yī)藥大學賽恩斯新醫(yī)藥學院科研項目（2022CX004， 2022MS008， 2022QJ001）；廣西中醫(yī)藥大學賽恩斯新醫(yī)藥學院國家級大學生創(chuàng)新創(chuàng)業(yè)訓練項目（202413643007）