Objective To evaluate the clinical efficacy of Biejiaruangan compound tablets in the treatment of primary biliary cirrhosis( PBC). Methods In a randomized,double- blind,placebo- controlled study,56 patients with PBC were collected and equally divided into treatment group and control group. The treatment group was given Biejiaruangan compound tablets( 4 pills per dose,3 doses per day,oral administration) combined with ursodeoxycholic acid( UDCA) tablets( 50 mg / pill,10- 15 mg per kg per day). The control group was given placebo( 4 pills per dose,3 doses per day,oral administration) combined with UDCA tablets( 50 mg / pill,10- 15 mg per kg per day). All patients were treated for 12 months. Clinical symptoms,PBC- 40 scales,liver function [alanine aminotransferase( ALT),aspartate aminotransferase( AST),alkaline phosphatase( ALP),γ- glutamyl transpeptidase( GGT),and total bilirubin( TBil) ],and liver stiffness values in the two groups were evaluated before and after treatment. Comparison of continuous data between the two groups was made by t test,and comparison of categorical data was made by chi- square test. Results The levels of ALT,AST,GGT,ALP,and TBil in the treatment group significantly decreased after 12 months of treatment( t = 3. 2019,P < 0. 01; t = 3. 0953,P < 0. 01; t = 3. 0279,P < 0. 01;t = 2. 4420,P < 0. 05; t = 2. 1621,P < 0. 05). In the control group,only the level of GGT significantly decreased after treatment( t =1. 9981,P < 0. 01). The levels of GGT and ALP were significantly lower in the treatment group than in the control group( t = 2. 0061,P <0. 05; t = 2. 3106,P < 0. 05). The liver stiffness value in the treatment group significantly decreased after treatment( 14. 37 ± 10. 58 vs10. 02 ± 5. 96 k Pa,t = 2. 1134,P < 0. 05). The PBC- 40 scales of skin itch,fatigue,and social dimension in the treatment group significantly decreased after treatment for 12 months( t = 2. 5158,P < 0. 05; t = 2. 1409,P < 0. 05; t = 3. 2441,P < 0. 05). There were significant differences in scales of fatigue and social dimension between the two groups after 12 months of treatment( t = 3. 1491,P < 0. 05; t =2. 6287,P < 0. 05). Conclusion Biejiaruangan compound tablets can significantly improve liver function,reduce the liver stiffness value,and improve PBC- 40 scales of skin itch and fatigue in patients with PBC. This therapy holds promise for widespread clinical application.
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