软肝颗粒联合恩替卡韦治疗乙肝肝硬化代偿期活动期临床研究

Clinical Study on Ruangan Granules Combined with Entecavir for Treatment of Active Compensation Period of Hepatitis B Cirrhosis

【目的】观察软肝颗粒联合恩替卡韦治疗乙肝肝硬化代偿期活动期患者的临床疗效。【方法】将90例乙肝肝硬化代偿期活动期患者按2∶1比例随机分为治疗组60例和对照组30例。对照组给予恩替卡韦片治疗,治疗组在对照组基础上给予口服软肝颗粒治疗,疗程为96周。观察2组患者治疗前后肝功能指标[谷丙转氨酶(ALT)、谷草转氨酶(AST)、谷氨酰转肽酶(GGT)、总胆红素(TBIL)、血清白蛋白(ALB)和白蛋白/球蛋白比值(A/G)]及乙肝病毒学指标[乙肝表面抗原(HBsAg)、乙肝病毒e抗原(HBeAg)和乙肝病毒脱氧核糖核酸(HBV-DNA)]定量水平的变化情况,评价2组患者治疗后的肝组织病理学疗效和肝脾超声疗效。【结果】(1)治疗48周和96周后,2组患者的ALT、AST、GGT、TBIL、HBsAg、HBeAg、HBV-DNA水平均较治疗前下降,ALB、A/G水平均较治疗前上升,差异均有统计学意义(P<0.05)。组间比较,治疗48周后,治疗组的ALB、A/G水平高于同期对照组,HBeAg、HBV-DNA水平均低于同期对照组,差异均有统计学意义(P<0.05),而2组的ALT、AST、GGT、TBIL、HBsAg水平比较,差异均无统计学意义(P>0.05)。治疗96周后,治疗组的AST、GGT、TBIL、HBsAg、HBeAg、HBV-DNA水平均低于同期对照组,A/G水平高于同期对照组,差异均有统计学意义(P<0.05),而2组的ALT、ALB水平比较,差异无统计学意义(P>0.05)。(2)肝组织病理学疗效方面,治疗96周后,治疗组的有效率为58.33%(35/60),对照组为33.33%(10/30),治疗组的肝组织病理学疗效明显优于对照组(P<0.05),且治疗后2组均无患者的肝组织病理学评价达到恶化标准。(3)肝脾超声疗效方面,治疗48周后,治疗组的有效率为33.33%(20/60),对照组为23.33%(7/30),组间比较,差异无统计学意义(P>0.05)。治疗96周后,治疗组的有效率为63.33%(38/60),对照组为40.00%(12/30),治疗组的肝脾超声疗效优于对照组(P<0.05)。【结论】软肝颗粒具有一定的改善肝功能、抑制HBV复制、抗肝纤维化的作用,且其安全性良好。

Objective To observe the clinical efficacy of Ruangan Granules combined with entecavir for the treatment of patients with active compensation period of hepatitis B cirrhosis. Methods A total of 90 patients with active compensation period of hepatitis B cirrhosis were randomly divided into two groups,30 cases in the control group and 60 cases in the treatment group. The control group was given oral use of entecavir,and the treatment group was treated with Ruangan Granules combined with entecavir orally. The course of the treatment for the two groups lasted for 96 weeks. Before and after treatment,the changes in the liver function indicators such as alanine transaminase(ALT),aspartate transaminase(AST),gamma-glutamyl transpeptidase(GGT),total bilirubin(TBIL),albumin(ALB),and ratio of albumin to globulin(A/G),as well as the virology indexes of hepatitis B virus(HBV)such as hepatitis B surface antigen(HBsAg),hepatitis B e antigen(HBeAg),and HBV-DNA in the two groups were observed. After treatment,the clinical efficacy showed by hepatic histopathology and liver and spleen B-ultrasonography was compared between the two groups. Results(1)After 48 and 96 weeks of treatment,the levels of ALT, AST, GGT, TBIL, HBsAg, HBeAg and HBV-DNA in the two groups were decreased significantly as compared with those before treatment(P < 0.05),and the levels of ALB and A/G were increased significantly in comparison with those before treatment(P < 0.05). The intergroup comparison showed that after 48 weeks of treatment,the levels of ALB and A/G in the treatment group were higher than those in the control group at the same time(P < 0.05),and the levels of HBeAg and HBV-DNA in the treatment group were lower than those in the control group at the same time(P < 0.05),but there were no significant differences in ALT,AST,GGT,TBIL and HBsAg levels between the two groups(P > 0.05). After 96 weeks of treatment, the levels of AST,GGT,TBIL,HBsAg,HBeAg and HBV-DNA in the treatment group were lower than those in the control group at the same time,and the A/G level in the treatment group was higher than that in the control group at the same time(P < 0.05),but there were no significant differences in the levels of ALT and ALB between the two groups(P >0.05).(2)In respect to the clinical efficacy showed by hepatic histopathology, the total effective rate in the treatment group after 96 weeks of treatment was 58.33%,and that in the control group was 33.33%,indicating that the hepatic histopathology efficacy in the treatment group was superior to that in the control group(P<0.05),and the hepatic histopathology in the two groups did not arrive to the criteria of deterioration after treatment.(3)In respect to the clinical efficacy showed by liver and spleen B-ultrasonography, the total effective rate in the treatment group after treatment for 48 weeks was 33.33%, and that in the control group was 23.33%, the difference being not statistically significant(P>0.05);after treatment for 96 weeks,the total effective rate in the treatment group was 63.33%, and that in the control group was 40.00%, the difference being statistically significant(P < 0.05). The results showed that the treatment group had stronger efficacy showed by liver and spleen B-ultrasonography than that in the control group(P<0.05). Conclusion Ruangan Granules have certain effects on improving liver function, inhibiting HBV replication and counteracting hepatic fibrosis in patients with active compensation period of hepatitis B cirrhosis,and have good safety.