消胀方联合恩替卡韦治疗乙肝肝纤维化/肝硬化疗效观察

Efficacy of Xiaozhang decoction combined with entecavir on hepatitis B hepatic fibrosis/cirrhosis

目的观察消胀方联合恩替卡韦治疗乙肝肝纤维化/肝硬化肝郁脾虚型患者的临床疗效。方法选择2016年1月-2020年1月上海中医药大学附属曙光医院治疗的乙肝肝纤维化/肝硬化肝郁脾虚型患者100例,采用随机对照方法将其分为治疗组和对照组,每组50例。治疗组予消胀方联合恩替卡韦治疗,对照组予恩替卡韦治疗,2组疗程均为12个月。比较2组治疗前及治疗12个月后中医证候积分及治疗12个月后中医证候疗效,观察比较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)、白蛋白(ALB)、总胆红素(TBil)]、HBV-DNA定量、细胞免疫功能指标、肝硬化程度(肝脏Fibroscan弹性值,APRI评分,FIB-4评分),肝纤维化指标[血清透明质酸(HA)、Ⅲ型前胶原(PCⅢ)、层黏蛋白(LN)和Ⅳ型胶原(Ⅳ-C)]、肝脏B超积分、肝脏CT分级。结果治疗组47例、对照组46例完成研究。治疗12个月后,治疗组中医证候总有效率为78.72%(13/47),明显高于对照组的56.52%(26/46),差异有统计学意义(P<0.05);2组患者ALT、AST水平及HBV-DNA定量均明显下降(P均<0.05),且治疗组均明显低于对照组(P均<0.05);2组患者NK细胞、CD8+均明显升高(P均<0.05),CD4+与CD4+/CD8+均明显下降(P均<0.05),且治疗组NK细胞、CD8+均明显高于对照组(P均<0.05);2组患者Fibroscan弹性值、APRI评分、FIB-4评分均明显下降(P均<0.05),且治疗组均明显低于对照组(P均<0.05);2组Ⅳ-C和HA水平均明显下降(P均<0.05),且治疗组均明显低于对照组(P均<0.05);2组PCⅢ、LN、B超积分和肝脏CT分级与治疗前比较差异均无统计学意义(P均>0.05)。结论消胀方联合恩替卡韦能够促进乙肝肝纤维化/肝硬化患者肝功能的恢复,提高机体免疫力,有利于病毒清除,减轻肝纤维化/肝硬化程度,疗效优于单独应用恩替卡韦抗病毒治疗。

Objective It is to observe the clinical efficacy of Xiaozhang decoction combined with entecavir in the treatment of patients with hepatitis B liver fibrosis/cirrhosis of type of liver stagnation and spleen deficiency.Methods One hundred patients with with hepatitis B liver fibrosis/cirrhosis of type of liver stagnation and spleen deficiency treated in Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from January 2016 to January 2020 were randomly divided into treatment group and control group,with 50 cases in each group.The treatment group was treated with Xiaozhang decoction combined with entecavir,while the control group was treated with entecavir,both groups were treated for 12 months.The traditional Chinese medical syndrome scores before and after 12 months of treatment and the efficacy of traditional Chinese medical syndrome after 12 months of treatment were compared between the two groups,and the liver function indicators[alanine transaminase(ALT),aspartate transaminase(AST),albumin(ALB),total bilirubin(TBil)],HBV-DNA quantification,cellular immune function indicators,degree of cirrhosis(hepatic fibroscan elastic value,APRI score,FIB-4 score),liver fibrosis indicators[serum hyaluronic acid(HA),typeⅢprocollagen(PCⅢ),laminin(LN),and typeⅣcollagen(Ⅳ-C)],liver ultrasound scores,and liver CT classification before and after treatment were observed and compared between the two groups.Results Forty-seven patients in the treatment group and 46 patients in the control group completed the study.After 12 months of treatment,the total effective rate of traditional Chinese medicine syndrome in the treatment group was 78.72%(13/47),which was significantly higher than that 56.52%(26/46)in the control group,the difference was statistically significant(P<0.05);The levels of ALT,AST and HBV-DNA of the patients in both groups were decreased significantly(all P<0.05),and the decrease in the treatment group was more significant than that in the control group(P<0.05);NK cells and CD8+of the patients in both group were significantly increased while CD4+and CD4+/CD8+were significantly decreased(all P<0.05),and NK cells and CD8+in the treatment group were significantly higher than those in the control group(all P<0.05);The Fibroscan elastic value,APRI score,and FIB-4 score of both groups of patients significantly decreased(P<0.05),and the treatment group was significantly lower than the control group(P<0.05);The levels of IV-C and HA of the patients in both groups were decreased significantly(all P<0.05),and the treatment group was significantly lower than the control group(P<0.05);There were no statistically significant differences in PC III,LN,B-ultrasound scores,and liver CT classification compared with before treatment in the two groups(all P>0.05).Conclusion Xiaozhang decoction combined with entecavir can promote the recovery of liver function,improve the immunity of the body,help to eliminate the virus,and reduce the degree of liver fibrosis/cirrhosis in patients with hepatitis B liver fibrosis/cirrhosis,its curative effect is better than that of entecavir alone.