Abstract
Objective To observe the clinical efficacy of ursodeoxycholic acid (UDCA) and Fuzheng Hua-yu Capsule (FHC) in the treatment of primary biliary cirrhosis (PBC). Methods Eighty PBC patients were randomly assigned to two groups, the treatment group and the control group, 40 in each group. Patients in the treatment group took UDCA and FHC, while those in the control group were treated with UDCA alone. The treatment course was 48 weeks for both groups. The clinical symptoms and signs, liver function indices (ALT, AST, ALP, GGT, ALB, TBIL, and TBA), hepatic fibrosis indices (HA, LN, IV-CL, and PIP), immunologic indices (IgG, IgM, and autoimmune antibodies), changes of portal hemodynamics, and adverse reactions were observed before treatment, as well as at week 4, 12, 24, and 48 after treatment. Results After treatment the skin itching and fatigue were significantly improved in the treatment group, showing statistical difference when compared with the control group (P<0. 05, P<0. 01). After treatment the levels of ALT, AST, ALP, GGT, TBIL, and TBA obviously decreased in the two groups. They were lower in the treatment group than in the control group at the same time point (P <0. 05). The decrement was the largest at week 4. Besides, at week 48 after treatment the ALB level was improved in the treatment group (P<0. 05). The levels of HA and PⅢP obviously decreased at week 4,12, and 24, the levels of LN and IV-C obviously decreased at week 4 and 12, the decrement of the hepatic fibrosis indices at week 4 were more obvious in the treatment group. But the levels of HA and PIP were lower than the pre-treatment levels at week 12 in the control group. The immunologic indices such as IgM and IgG were improved in the twogroups, with better results obtained in the treatment group (P <0. 05, P <0. 01). In the treatment group ANA turned negative in 1 patient and AMA turned negative in 2 patients. After 48 weeks of treatment, the spleen was retracted , the inner diameters of the portal vein (PV) and the splenic vein (SV) were significantly reduced, and the blood flow velocity in the PV and SV increased in the treatment group (P<0. 01). At week 24 and 48, 33 patients (82. 5%) and 26 patients (90. 0%) in the treatment group had complete relief, better than those of the control group [22 cases (55. 0%) and 28 cases (70. 0%) ]. No obvious adverse reaction was found in the two groups during the treatment course. Conclusions The combination therapy of UDCA and FHC was effective and safe in anti-fibrosis and improving the liver functions of PBC patients. It was safe and better than the application of UDCA a-lone. It was advocated to be combined use for a long term. It might improve the long-term efficacy.关键词
熊去氧胆酸/扶正化瘀胶囊/原发性胆汁性肝硬化Key words
ursodeoxycholic acid/ Fuzheng Huayu Capsule/ primary biliary cirrhosis
