运用疏肝健脾法治疗乙肝肝纤维化的临床疗效评价

Evaluation of Clinical Effect of Therapy of Soothing Liver and Invigorating Spleen for Treatment of Hepatitis B Associated Hepatic Fibrosis

【目的】观察以疏肝健脾法组方而成的和合疏养方治疗肝郁脾虚型慢性乙型病毒性肝炎(简称乙肝)肝纤维化的临床疗效。【方法】采用随机对照研究方法,将100例肝郁脾虚型乙肝肝纤维化患者按1∶1的比例随机分为治疗组和对照组,每组各50例。对照组给予恩替卡韦抗病毒治疗,治疗组在对照组恩替卡韦治疗的基础上联合和合疏养方治疗,疗程为48周。观察2组患者治疗前后中医证候评分、肝功能指标[谷丙转氨酶(ALT)、谷草转氨酶(AST)]和肝脏硬度值(LSM)的变化情况,评价2组患者在治疗48周后的ALT和AST复常率。【结果】(1)治疗48周后,2组患者的中医证候评分均较治疗前明显降低(P<0.05),且治疗组的降低作用明显优于对照组,差异有统计学意义(P<0.05)。(2)治疗后各观察时点,2组患者的ALT和AST水平均较治疗前降低(P<0.05),且治疗组在治疗12周后对ALT水平的降低作用明显优于对照组,差异有统计学意义(P<0.05)。(3)治疗12周后,治疗组患者的ALT、AST复常率分别为92.0%(46/50)和96.0%(48/50),均明显高于对照组的56.0%(28/50)和50.0%(25/50),差异均有统计学意义(P<0.05)。治疗48周后,2组患者的肝功能均完全恢复正常,ALT、AST复常率均为100.0%(50/50),差异均无统计学意义(P>0.05)。(4)治疗后各观察时点,2组患者的LSM值均较治疗前明显降低(P<0.05),且治疗组在治疗48周后对LSM值的降低作用略优于对照组,差异有统计学意义(P<0.05)。【结论】运用以疏肝健脾法组方而成的和合疏养方治疗肝郁脾虚型乙肝肝纤维化,可以明显改善患者临床症状,有效促进肝功能复常,逆转乙肝肝纤维化进程,提高临床治疗效果。

Objective To observe the clinical efficacy of Hehe Shuyang Recipe,a prescription with the actions of soothing liver and invigorating spleen for treatment of hepatitis B associated hepatic fibrosis with the syndrome of liver stagnation and spleen deficiency.Methods A randomized control trial was adopted,and 100 patients with hepatitis B associated hepatic fibrosis with the syndrome of liver stagnation and spleen deficiency were equally divided into the treatment group and the control group in a proportion of 1∶1,50 cases in each group.The control group was given antiviral treatment with entecavir,and the treatment group was treated with Hehe Shuyang Recipe combined with entecavir treatment.The treatment for the two groups covered 48 weeks.Before and after treatment,the scores of traditional Chinese medicine(TCM)syndrome,the levels of hepatic function indexes of alanine transaminase(ALT)and aspartate transaminase(AST),and the value of liver stiffness measurement(LSM)in the two groups were observed.After treatment for 48 weeks,the rates for ALT and AST recovering to normal in the two groups were evaluated.Results(1)After treatment for 48 weeks,the scores of TCM syndrome in the two groups were decreased in comparison with those before treatment,and the decrease in the treatment group was superior to that in the control group,the difference being statistically significant(P<0.05).(2)At various post-treatment time points,the serum levels of ALT and AST in the 2 groups were decreased in comparison with those before treatment,and the difference was statistically significant(P<0.05).The treatment group had stronger effect on decreasing ALT level after treatment for 12 weeks,and the difference was statistically significant(P<0.05).(3)After treatment for 12 weeks,the rates for ALT and AST recovering to normal in the treatment group were 92.0%(46/50)and 96.0%(48/50),and the rates for ALT and AST recovering to normal in the control group were 56.0%(28/50)and 50.0%(25/50)respectively,the difference being statistically significant(P<0.05).After treatment for 48 weeks,the hepatic function in the two groups all recovered to normal,and the rates for ALT and AST recovering to normal in the two groups all were 100%(50/50),the difference being not statistically significant(P>0.05).(4)At various post-treatment time points,LSM value in the two groups was obviously decreased in comparison with that before treatment(P<0.05),and the effect on decreasing LSM value in the treatment group after 48 weeks was superior to that in the control group,the difference being statistically significant(P<0.05).Conclusion Hehe Shuyang Recipe prescribed under the principle of soothing liver and invigorating spleen is effective for the treatment of hepatitis B associated hepatic fibrosis differentiated as liver stagnation and spleen deficiency.The prescription is effective the on relieving the clinical symptoms,promoting the recovery of hepatic function,reversing the process of hepatic fibrosis,and enhancing the clinical efficacy.