柔肝化纤颗粒联合恩替卡韦对乙肝肝硬化腹水患者肝纤维化、凝血功能和氧化应激的影响

Effects of Rougan Huaxian Granules Combined with Entecavir on Liver Fibrosis,Coagulation Function and Oxidative Stress in Patients with Hepatitis B Induced Liver Cirrhosis with Ascites

【目的】探讨柔肝化纤颗粒(由黄精、薏苡仁、黄芪、枸杞子、鳖甲等中药组成)联合恩替卡韦治疗乙肝肝硬化腹水患者的临床疗效。【方法】将76例乙肝肝硬化腹水(肝肾阴虚水停证)患者随机分为研究组和对照组,每组各38例。2组患者均给予保肝、利尿、纠正低蛋白血症等支持治疗,在此基础上,对照组给予恩替卡韦治疗,研究组在对照组基础上给予柔肝化纤颗粒治疗,疗程为4周。观察2组患者治疗前后中医证候积分、体质量、腹围、24 h尿量、肝功能、凝血功能、肝纤维化、氧化应激指标的变化情况,并评价2组患者的临床疗效。【结果】(1)治疗4周后,研究组的总有效率为92.11%(35/38),对照组为73.68%(28/38),组间比较,研究组的临床疗效明显优于对照组(P<0.05)。(2)治疗后,2组患者的中医证候积分均较治疗前明显下降(P<0.01),且研究组对中医证候积分的下降作用明显优于对照组(P<0.01)。(3)治疗后,2组患者的谷丙转氨酶(ALT)、谷草转氨酶(AST)、总胆红素(TBIL)水平均较治疗前下降(P<0.05),白蛋白(ALB)水平均较治疗前升高(P<0.05),且研究组对AST、ALT、TBIL水平的下降作用及对ALB水平的升高作用均明显优于对照组(P<0.01)。(4)治疗后,2组患者的凝血酶原时间(PT)均较治疗前缩短(P<0.05),凝血酶原活动度(PTA)均较治疗前提高(P<0.05),且研究组对PT的缩短作用及对PTA的提高作用均明显优于对照组(P<0.01)。(5)治疗后,2组患者的体质量、腹围、24 h尿量均较治疗前改善(P<0.05),且研究组对体质量、腹围、24 h尿量的改善作用均明显优于对照组(P<0.05或P<0.01)。(6)治疗后,2组患者的透明质酸(HA)、Ⅲ型前胶原(PCⅢ)、层黏连蛋白(LN)、Ⅳ型胶原(Ⅳ-C)等肝纤维化指标均较治疗前改善(P<0.05),且研究组对各项肝纤维化指标的改善作用均明显优于对照组(P<0.01)。(7)治疗后,2组患者的丙二醛(MDA)、一氧化氮(NO)水平均较治疗前下降(P<0.05),超氧化物歧化酶(SOD)水平均较治疗前升高(P<0.05),且研究组对MDA、NO水平的降低作用及对SOD水平的升高作用均明显优于对照组(P<0.01)。【结论】柔肝化纤颗粒联合恩替卡韦治疗乙肝肝硬化腹水,能有效改善患者临床症状,减少腹水,减轻肝纤维化程度,改善肝功能和凝血功能,减轻氧化应激反应,疗效显著。

Objective To investigate the clinical efficacy of Rougan Huaxian Granules(composed of Polygonati Rhizoma,Coicis Semen,Astragali Radix,Lycii Fructus,Trionycis Carapax,etc.)with Entecavir in the treatment of patients with hepatitis B induced liver cirrhosis with ascites.Methods Seventy-six patients suffering from hepatitis B induced liver cirrhosis with ascites and differentiated as liver-kidney yin deficiency with water retention syndrome were randomly divided into the study group and the control group,with 38 patients in each group.Both groups of patients were given supportive treatment of protecting liver,promoting diuresis and correcting hypoproteinemia. And additionally,the control group was treated with Entecavir Tablets orally and thestudy group was given Rougan Huaxian Granules plus Entecavir Tablets orally. Both groups were treated for4 weeks. The changes in traditional Chinese medicine(TCM) syndrome scores, body mass, abdominalcircumference,24-hour urine volume,and the indexes of liver function,coagulation function,liver fibrosis andoxidative stress in the two groups were observed before and after treatment. After treatment,the clinical efficacy ofthe two groups was evaluated. Results (1)After 4 weeks of treatment,the total effective rate of the study groupwas 92.11%(35/38)and that of the control group was 73.68%(28/38). The intergroup comparison showed that theclinical efficacy of the study group was significantly superior to that of the control group(P<0.05).(2)Aftertreatment,the TCM syndrome scores of patients in both groups were significantly decreased compared with thosebefore treatment(P<0.01), and the decrease of TCM syndrome scores in the study group was significantlysuperior to that in the control group(P<0.01).(3)After treatment, the levels of hepatic function indexes ofalanine transaminase(ALT), aspartate aminotransferase(AST)and total bilirubin(TBIL)in both groups weredecreased and the level of albumin(ALB)was increased compared with those before treatment(P<0.05),and theeffect on decreasing AST, ALT and TBIL levels and on increasing the ALB level in the study group wassignificantly superior to that in the control group(P<0.01).(4)After treatment,the coagulation function indexesof prothrombin time(PT)in both groups was shortened and the prothrombin activity(PTA)was improved comparedwith those before treatment(P<0.05),and the effect on shortening the PT and on increasing the PTA in the studygroup was significantly superior to that in the control group(P<0.01).(5)After treatment, the body mass,abdominal circumference and 24-hour urine volume in both groups were improved compared with those beforetreatment(P<0.05),and the improvement of the above indicators in the study group was significantly superior tothat in the control group(P<0.05 or P<0.01).(6)After treatment,the hepatic fibrosis indexes of hyaluronic acid(HA),pre-collagen type Ⅲ(PCⅢ),laminin(LN)and collagen type Ⅳ(Ⅳ-C)were improved in both groupscompared with those before treatment(P<0.05),and the improvement of the hepatic fibrosis indexes in the studygroup was significantly superior to that in the control group(P<0.01).(7)After treatment,the levels of oxidativestress indicators of malondialdehyde(MDA)and nitric oxide(NO)in both groups were decreased(P<0.05)andsuperoxide dismutase(SOD)level was increased(P<0.05)compared with those before treatment,and the effecton decreasing MDA and NO levels and on increasing SOD level in the study group was stronger than that in thecontrol group(P<0.01). Conclusion Rougan Huaxian Granules combined with Entecavir exerts certain efficacyfor the treatment of hepatitis B induced liver cirrhosis with ascites, and the therapy is effective on relievingclinical symptoms, reducing ascites, alleviating the degree of liver fibrosis, improving liver function andcoagulation function,and relieving oxidative stress.