恩替卡韦联合复方鳖甲软肝片治疗慢性乙型肝炎患者疗效观察

目的 观察复方鳖甲软肝片联合恩替卡韦分散片（ETV）治疗慢性乙型肝炎（CHB）的临床疗效。方法 将138例慢性乙型肝炎患者随机分为复方鳖甲软肝片和恩替卡韦分散片联合治疗73例和恩替卡韦分散片单药治疗65例,观察两组患者肝功能、乙型肝炎病毒（HBV）血清学标志物、HBV DNA定量、肝纤维化指标、腹部彩超检查的变化及药物不良反应。结果 治疗48w后,两组患者肝功能与治疗前基线水平相比均显著改善[联合组治疗前后ALT为（118.7±70.9） U/L 对 （32.6±21.5） U/L，P＜0.01；ALB为（38.5±3.8） g/L 对 （43.2±4.5） g/L，P＜0.01]；两组患者血清HBV DNA定量下降到检测水平以下的发生率分别为85.33％（64/73）和86.15％（56/65），HBeAg血清学转换率分别为27.78%和15.15%（P>0.05）；在治疗48w时，联合治疗组血透明质酸（HA）和脾脏长径分别为（172.40±58.16） μg/L 和（10.15±0.12） cm，均较基线水平显著降低[（365.17±119.07） μg/L和（12.08±0.16） cm，P＜0.05]，且联合治疗组疗效优于单药组[HA为（218.13±75.32） μg/L，脾脏长径（11.90±0.20）cm，P＜0.05]。结论 ETV 联合复方鳖甲软肝片治疗CHB患者疗效优于单用ETV，值得进一步验证。

Clinical efficacy of Fufang Biejia Ruangan tablet combined with entecavir in treatment of patients with chronic hepatitis B

Objective To observe the clinical efficacy of Fufang Biejia Ruangan tablet （FBR） combined with entecavir （ETV） in the treatment of patients with chronic hepatitis B （CHB）. Methods A total of 138 patients with CHB were enrolled and divided into two groups（73 in FBR plus ETV group，and 65 patients in ETV monotherapy group）. Liver functions，HBV serological indicators，HBV DNA quantification，liver fibrosis markers，results of abdominal ultrasound and adverse drug reactions were recorded. Results The liver functions in both groups had been improved after 48-weeks treatment compared with those before treatment. ALT levels before and after treatment in patients of combination group were[（118.7±70.9） U/L vs. （32.6±21.5） U/L，P<0.01] and ALB before and after treatment in combination group were [（38.5±3.8） g/L vs. （43.2±4.5） g/L，P<0.01]；No significant difference was seen between the two groups in serum clearance rate of HBV DNA and negative conversion rate of HBeAg [85.33% （64/73） vs. 86.15% （56/65），and 27.78% vs. 15.15%，respectively，P>0.05 for both]； Serum hyaluronic acid （HA） and length of spleen in combination group reduced remarkably after 48-weeks treatment compared with those before treatment [（172.40±58.16） μg/L vs. （365.17±119.07） μg/L for HA， P<0.01 and （10.15±0.12） cm vs. （12.08±0.16） cm for the length of spleen，P<0.05]. Conclusion ETV combined with FBR provides better efficacy than ETV alone in the treatment of patients with CHB.