软肝抗纤方联合恩替卡韦与维生素D3治疗乙型肝炎肝硬化代偿期患者的临床疗效及对其免疫功能的影响

Curative Efficacy of Ruangan Kangxian Formula Combined with Entecavir and Vi-tamin D3 on Patients with Compensated Hepatitis B Cirrhosis and Its Effect on Immune Function

目的 探讨软肝抗纤方联合恩替卡韦与维生素D3对乙型肝炎肝硬化(Hepatitis B cirrhosis, HBC)代偿期患者的临床疗效及免疫功能的影响。方法 选取2021年1月—2022年1月期间华北石油管理局总医院门诊收治的代偿期HBC患者120例,按照随机数字表法分为对照组和观察组,每组各60例。对照组予恩替卡韦加维生素D3治疗,观察组在对照组基础上联用软肝抗纤方治疗。治疗24周后,观察比较两组患者临床疗效,治疗前后肝功能指标[天门冬氨酸氨基转移酶(Aspartate aminotransferase, AST)、丙氨酸氨基转移酶(Alanine aminotransferase, ALT)、白蛋白(Albumin, ALB)和总胆红素(Total bilirubin, TBil)]、肝纤维化指标[层黏连蛋白(Laminin, LN)、透明质酸(Hyaluronic acid, HA)、Ⅲ型前胶原(Type III procollagen, PCⅢ)、Ⅳ型胶原(Type IV collagen,Ⅳ-C)]、免疫功能指标[CD4^(+)、CD8^(+),并计算CD4^(+)/CD8^(+)],评价中医证候评分与慢性肝脏疾病特异性量表(The chronic liver disease-specific questionnaire, CLDQ)评分。结果 治疗24周后两组患者中医证候评分较治疗前降低,差异有统计学意义(P<0.05);且观察组评分低于对照组,差异有统计学意义(P<0.05)。治疗24周后观察组总有效率96.67%(58/60)高于对照组83.33%(50/60),差异有统计学意义(P<0.05)。治疗24周后肝功能指标AST、ALT和TBil均较治疗前降低,ALB较治疗前升高,差异有统计学意义(P<0.05);且观察组肝功能指标ALT、AST和TBil低于对照组,ALB高于对照组,差异有统计学意义(P<0.05)。治疗24周后,两组患者肝纤维化指标LN、HA、PCⅢ和Ⅳ-C均较治疗前降低,差异有统计学意义(P<0.05);且观察组低于对照组,差异有统计学意义(P<0.05)。治疗24周后两组患者CD4^(+)、CD8^(+)、CD4^(+)/CD8^(+)均较治疗前升高,差异有统计学意义(P<0.05);且观察组CD4^(+)、CD4^(+)/CD8^(+)高于对照组,差异有统计学意义(P<0.05);CD8^(+)与对照组比较,差异无统计学意义(P>0.05)。治疗24周后两组患者生活质量CLDQ评分均较治疗前升高,差异有统计学意义(P<0.05);且观察组高于对照组,差异有统计学意义(P<0.05)。观察组不良反应率5.00%(3/60)与对照组1.67%(1/60)比较,差异无统计学意义(P>0.05)。结论 软肝抗纤方联合恩替卡韦与维生素D3治疗HBC可提高临床疗效,调节免疫功能,改善临床症状及肝功能,改善肝纤维化。

Objective To investigate the clinical efficacy of Ruangan Kangxian Formula combined with entecavir and vitamin D3 on patients with compensated hepatitis B cirrhosis(HBC)and its effect on immune function.Methods A total of 120 compensated HBC patients treated at the Outpatient Department of Huabei Petroleum General Hospital from January 2021 to January 2022 were enrolled and randomly divided into a control group and an observation group,with 60 patients in each group.The control group received entecavir and vitamin D3 treatment,while the observation group received Ruangan Kangxian Formula combined with entecavir and vitamin D3.After 24 weeks of treatment,the clinical efficacy of the two groups of patients was observed and compared.Liver function indicators[aspartate aminotransferase(AST),alanine amin-otransferase(ALT),albumin(ALB),and total bilirubin(TBil)],liver fibrosis indicators[laminin(LN),hyaluronic acid(HA),type III procollagen(PCⅢ),and type IV collagen(Ⅳ-C)],and immune function indicators[CD4^(+),CD8^(+),and CD4^(+)/CD8^(+)]were measured before and after treatment.Traditional Chinese medicine(TCM)syndrome scores and Chronic Liver Disease Questionnaire(CLDQ)scores were also evaluated.Results After 24 weeks of treatment,the TCM syndrome scores of both groups of patients decreased compared with those before treatment(P<0.05),and the observation group had lower scores than the control group(P<0.05).The total effective rate of the observation group after 24 weeks of treatment was 96.67%(58/60),which was higher than 83.33%(50/60)of the control group(P<0.05).After 24 weeks of treat-ment,the liver function indicators AST,ALT,and TBil were decreased compared with those before treatment,while ALB was increased(P<0.05).The observation group had lower levels of ALT,AST,and TBil and a higher level of ALB than the control group(P<0.05).After 24 weeks of treatment,the liver fibrosis indicators LN,HA,PCⅢ,andⅣ-C were de-creased compared with those before treatment(P<0.05),and the observation group had lower levels of these indicators than the control group(P<0.05).After 24 weeks of treatment,the immune function indicators CD4^(+),CD8^(+),and CD4^(+)/CD8^(+)were increased compared with those before treatment(P<0.05),and the observation group had higher levels of CD^(+)and CD4^(+)/CD8^(+)than the control group(P<0.05).There was no statistically significant difference in CD8^(+)be-tween the observation group and the control group(P>0.05).After 24 weeks of treatment,the CLDQ scores indicating quality of life were increased compared with those before treatment(P<0.05).The observation group had higher CLDQ scores than the control group(P<0.05).The incidence of adverse reactions in the observation group(5.00%,3/60)was not statistically significantly different from the control group(1.67%,1/60)(P>0.05).Conclusion Ruangan Kangxian Formula combined with entecavir and vitamin D3 in the treatment of HBC can improve clinical efficacy,regulate immune function,improve clinical symptoms and liver function,and ameliorate liver fibrosis.