复方鳖甲软肝片联合恩替卡韦治疗代偿期乙型肝炎肝硬化的疗效及成本效益分析

Clinical Effect and Cost-Effective Analysis of Compound Biejia Ruangan Tablets Combined with Entecavir Tablets on Fibrosis in Compensated Cirrhosis

目的应用肝纤维化无创扫描仪评价复方鳖甲软肝片联合恩替卡韦治疗代偿期乙型肝炎肝硬化患者的疗效及成本效益。方法 2011年6月至2012年6月,前瞻性纳入患者183例,随机分为联合治疗组(98例,复方鳖甲软肝片2 g,每日3次;恩替卡韦片0.5 mg,每日1次,口服)、单药治疗组(85例,恩替卡韦片0.5 mg,每日1次,口服),疗程为24个月,观察2组患者肝硬度指标变化及肝功能复常率、乙型肝炎病毒阴转率、HBe Ag阴转率、肝癌及肝硬化失代偿发生率,并对肝硬度好转所需成本进行分析。结果治疗24个月后联合治疗组较单药治疗组肝硬度下降明显〔(12.6±3.8)k Pa vs(17.6±2.2)k Pa,P<0.05〕;出现肝硬度下降比例更高(81/98 vs 43/85),(P<0.05);肝功能复常率、HBV-DNA阴转率、HBe Ag阴转率、肝癌及失代偿发生率2组均无显著差异。治疗6个月及24个月时,发生肝硬度下降几率每增加1%则增加治疗成本分别为2382元和505元。结论长期应用复方鳖甲软肝片联合恩替卡韦治疗代偿期乙型肝炎肝硬化较单独应用恩替卡韦可以减轻肝硬化程度,肝纤维化改善患者比例更多。从经济学角度考虑,抗病毒治疗6个月后再联合复方鳖甲软肝片治疗其成本效益更佳。

Objective To evaluate the effect and cost of compound Biejia Ruangan tablets combined with entecavir tablets on liver fibrosis by Fibro Scan in patients with cirrhosis. Methods From Jun,2011 to Jun,2012,183 patients were enrolled and randomly divided into two groups in this study（ 98 patients in combined treatment group,85 patients in monotherapy group）. During the 24-month treatment,the changes of liver stiffness（ LS） by Fibro Scan,liver function recovery rates,negative conversion ratios of hepatitis B virus DNA and hepatitis B e-antigen（ HBe Ag） and incidence of hepatocellular carcinoma and decompensated cirrhosis were observed between the two groups. A cost-effective analysis was conducted to estimate the cost of anti-fibrosis treatment. Results After 24-month treatment,LS of combined treatment group was lower than that of monotherapy group 〔（ 12. 6 ± 3. 8） k Pa vs（ 17. 6 ± 2. 2） k Pa,P〈0. 05〕. At the same time point,LS decreased more obviously in combined treatment group than in the other group（ 81 /98 vs 43 /85,P〈0. 05）. However,there was no significant difference in other results between the two groups（ P〈0. 05）. The corresponding incremental cost-effectiveness ratio was 2382 yuan per lower-LS gained after 6-month treatment and 505 yuan per lower-LS gained after 24-month treatment. Conclusion The combined treatment is better and more cost-effective.