Objective To investigate the clinical effect and safety of Kezhi capsules in the treatment of nonalcoholic steatohepatitis( NASH). Methods A total of 100 patients with NASH who visited The Eighth People's Hospital of Shanghai from November 2013 to December 2015 were enrolled and randomly divided into treatment group and control group,with 50 patients in each group. The patients in the treatment group were treated with Kezhi capsules and those in the control group were treated with polyene phosphatidylcholine capsules. The course of treatment was 24 weeks for each group. The changes in liver function,blood lipid,and liver / spleen CT ratio after treatment were observed in both groups. The two- independent- samples t test was used for comparison of continuous data between groups,and the paired- samples t test was used for comparison of continuous data within each group. The chi- square test was used for comparison of categorical data between groups. Results After treatment,the treatment group and the control group had significant improvements in the levels of aspartate aminotransferase( 49. 2 ± 21. 7 U / L vs 119. 5 ± 44. 2 U / L,t = 10. 0,P < 0. 01; 52. 4 ± 33. 1 U / L vs 115. 2 ± 48. 3 U / L,t = 7. 6,P < 0. 01),alanine aminotransferase( 41. 8 ± 14. 8 U / L vs 92. 8 ± 42. 1 U / L,t = 8. 1,P < 0. 01; 42. 9 ± 16. 6 U / L vs 95. 3 ± 40. 4 U / L,t = 8. 5,P < 0. 01),gamma- glutamyl transpeptidase( 52. 3 ± 23. 7 U / L vs 168. 4 ± 85. 9 U / L,t = 9. 2,P < 0. 01; 54. 8 ± 30. 2 U / L vs177. 6 ± 88. 7 U / L,t = 9. 3,P < 0. 01),triglyceride( TG)( 1. 78 ± 1. 01 mmol / L vs 3. 52 ± 2. 35 mmol / L,t = 4. 8,P < 0. 01; 2. 51 ±1. 08 mmol / L vs 3. 65 ± 2. 43 mmol / L,t = 3. 0,P = 0. 02),total cholesterol( TC)( 3. 81 ± 1. 28 mmol / L vs 6. 13 ± 5. 22 mmol / L,t =3. 0,P = 0. 02; 3. 63 ± 1. 39 mmol / L vs 5. 27 ± 4. 54 mmol / L,t = 2. 6,P = 0. 03),and liver / spleen CT ratio( 0. 94 ± 0. 16 vs 0. 74 ±0. 18,t = 5. 8,P < 0. 01; 0. 89 ± 0. 13 vs 0. 70 ± 0. 20,t = 5. 6,P < 0. 01). There were significant differences in these parameters between the two groups. At the end of treatment,the treatment group had significantly greater reductions in TC and TG levels than the control group( t = 3. 5 and 2. 8,both P < 0. 01). Conclusion Kezhi capsules can effectively improve liver function,reduce blood lipids,and reduce the degree of fatty degeneration of the liver,without significant toxic and side effects.
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