The Clinical Research Of Entecavir Combined Anluohuaxian Pills To Treat Hepatic Fibrosis With Chronic Hepatitis B

Background At present there are about 93 million people of chronic hepatitis B virus infection in our country, of which about 20 million patients with chronic hepatitis B.If without effective treatment, there are about 3%?5% patients with chronic hepatitis B progress for decompensated cirrhosis every year,leading to lower quality of life, and increased mortality. Hepatic fibrosis with Chronic Hepatitis B is essential pathologic stage and the intermediate links of to forming cirrhosis of the liver. It can delay or block the development of liver fibrosis and even make its reversal in the earlier stage of liver fibrosis,if we can improve the accuracy of diagnosis of liver fibrosis through safe and effective methods, and adopt comprehensive treatment measures.It will improve the prognosis of patients. So early detection, diagnosis, and intervention has very important clinical significance for liver fibrosis and cirrhosis.Objective 1.To observe the change of HBV-DNA quantitative and liver function(TBIL,ALT, AST, GLB) after the treatment with Entecavir combined Anluohuaxian Pill in patients with hepatic fibrosis with Chronic hepatitis B.2. To evaluate the efficiency of FibroScan,APRI, FIB-4, Forms, S index to the diagnosis of liver fibrosis stage S?3.Method 43 patients of chronic hepatitis B were randomly divided into the single medicine group and combined group.The patients must have liver fibrosis stage S?2 by liver biopsy pathological diagnosis. Twenty-one patients were treated with entecavir 0.5 mg every night.Twenty-two patients in combined group were given entecavir 0.5mg every night and anluohuaxian pill twice a day,6g each time. After 72 weeks, the result of the second liver biopsy pathological diagnosis, liver biochemical and imaging markers were analyzed to evaluate curative effect in both groups. And to evaluate the efficiency of FibroScan,APRI, FIB-4, Forms, S index to the diagnosis of liver fibrosis stage S?3 by ROC curve analysis method.Results1. The liver function of patients (ALT, AST) are better in the two groups after 72 weeks (P<0.05).There was no statistically significant difference (P>0.05) of TBIL and GLB among the two groups. The negative rate of HBV-DNA were 94.7% in single drug group and 100% in combined group, but it was no significant difference between the two groups (P=0.091). The spleen thickness of patients have obvious change in the two groups after 72 weeks treatment(p<0.05).Portal vein width decreased obviously after treatment for 72 weeks in combined group, but had no obvious improvement in single drug groups. The MELD score were improved in both groups after 72 weeks treatment, but it was obviously improved in ombined group compared with single drug group. The difference was statistically significant. The improvement rate of Fibroscan were 63.2% in single drug group and 95.5% in combined group. Difference between groups was statistically significant (P=0.016). Fibrosis stage were improved in the two groups after 72 weeks treatment.42.1% of the patients in single drug group were improved and 77.3% of the patients in combined group. It was statistical significance between the two groups(p=0.029).2. Area under the ROC curve used for the diagnosis of liver fibrosis stage?3 was 0.799 for FIB-4,0.770 for APRI,0.774 for Forms index and 0.731 for S index. FIB-4 is the highest diagnostic accuracy. Area under the ROC curve was 0.843 for Fibroscan. The diagnostic efficacy rate of Fibroscan was better than noninvasive diagnosis model such as FIB-4, APRI, Forms index and S index.Conclusions1. Entecavir combined anluohuaxian pill for the treatment of patients with hepatitis B liver fibrosis has no obvious advantage in improving liver function and HBV-DNA overcast rate compared with entecavir monotherapy.There are synergies in terms of improvement of liver fibrosis in combined group and can improve the prognosis of patients.2. FIB-4 is the highest diagnostic accuracy for diagnosis of liver fibrosis stage?3 in all of noninvasive diagnosis of liver fibrosis model,such as APRI, FIB-4, Forms and S index. The diagnostic efficacy rate of Fibroscan was better than noninvasive diagnosis model.