摘要目的探索慢性乙型肝炎病毒(HBV)感染者接受恩替卡韦单独或联合安络化纤丸治疗78周对肝纤维化的改善作用. 方法慢性HBV感染者随机接受恩替卡韦单独或联合安络化纤丸治疗78周,肝穿刺标本采用Ishak score盲态判读.比较患者治疗前后的肝纤维化改善情况.对计量资料采用Student's t检验、非参数检验(Mann-Whitney U-Test及Kruskal-Wallis检验)方法分析;计数资料采用Chi-squared 检验方法分析;Spearman分级检验法分析双变量相关性. 结果治疗78周后肝纤维化改善率为36.53%(80/219)、进展率为23.29%(51/219).肝纤维化改善与基线纤维化程度和治疗方法相关(P < 0.05).在安络化纤丸联合恩替卡韦治疗且基线肝纤维化评分(F)≥3的患者中,肝纤维改善率(54.74%,52/95)显著高于仅接受恩替卡韦治疗者(33.33%, 16/48),P = 0.016 ;联合治疗组肝纤维化进展比例(13.68%,13/95)在数值上低于单独治疗组(18.75%,9/48),P = 0.466.在基线F < 3的患者中,联合治疗组肝纤维化改善和稳定的患者比例(68.08%,32/47)高于单独治疗组(51.72%,15/29). 结论安络化纤丸联合恩替卡韦治疗可显著提高慢性HBV感染者肝纤维化的改善率,并有提高肝纤维化稳定率和降低进展率的趋势.

abstractsObjective To explore the improvement rate of liver fibrosis in patients with chronic hepatitis B virus infection who received entecavir alone or in combination with anluohuaxianwan for 78 weeks. Methods Patients with chronic HBV infection were randomly treated with entecavir alone or in combination with anluohuaxian for 78 weeks. Ishak fibrosis score was used for blind interpretation of liver biopsy specimens. The improvement in liver fibrosis condition before and after the treatment was compared. Student's t test and non-parametric test (Mann-Whitney U-Test and Kruskal-Wallis test) were used to analyze the measurement data. The categorical variables were analyzed by Chi-square test method and Spearman’s rank correlation coefficient was used to test bivariate associations. Results Liver fibrosis improvement rate after 78 weeks of treatment was 36.53% (80/219) and the progression rate was 23.29% (51/219). The improvement of liver fibrosis was associated to the degree of baseline fibrosis and treatment methods (P < 0.05). The improvement rate of hepatic fibrosis in patients treated with anluohuaxianwan combined with entecavir at baseline F < 3 (54.74%, 52/95) was significantly higher than that in patients treated only with entecavir (33.33%, 16/48), P = 0.016 and the progression rate of hepatic fibrosis (13.68%, 13/95) was lower than that in patients treated alone (18.75%, 9/48), P=0.466. In patients with baselineF<3, the proportion of patients with improved and stable liver fibrosis in the combined treatment group (68.1%, 32/47) was higher than that in the treatment group alone (51.7%, 15/29). Conclusion Combined anluohuaxianwan and entecavir treatment can significantly improve the improvement rate of liver fibrosis in patients with chronic hepatitis B virus infection. Furthermore, it has the tendency to improve the stability rate and reduce the rate of progression of liver fibrosis.