【摘要】 目的观察壳脂胶囊对非酒精性脂肪性肝炎的临床疗效及安全性。方法选取2013年11月-2015年12月于上海市第八人民医院就诊的非酒精性脂肪性肝炎(NASH)患者100例,随机分为治疗组、对照组各50例,分别予壳脂胶囊和多烯磷脂酰胆碱胶囊,疗程24周。观察两组治疗前后肝功能、血脂水平及肝/脾CT值的变化。计量资料组间比较采用两独立样本的t检验,组内比较采用配对样本t检验,计数资料组间比较采用χ2检验。结果两组患者治疗后AST[(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]、ALT[(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]、GGT[(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 vs(177.6±88.7)U/L,t=9.3,P<0.01]、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]、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]水平及肝/脾CT比值[肝/脾CT比值:(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]均较各自治疗前均明显改善。治疗结束时,治疗组在TC、TG水平下降较对照组更为明显,差异均有统计学意义(t值分别为3.5、2.8,P值均<0.01)。结论壳脂胶囊能有效改善肝功能,降低血脂水平,减轻肝脂肪变性程度,且无明显毒副作用。更多还原

【Abstract】 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.更多还原