甘草酸二铵胶囊联合双环醇片治疗轻症自身免疫性肝炎疗效观察

The analysis on efficacy of diammonium glycyrrhizinate combined with bicyclol in treatment of mild autoimmune hepatitis

目的探讨甘草酸二铵胶囊联合双环醇片治疗轻症自身免疫性肝炎的疗效和安全性。方法自身免疫性肝炎患者60例,随机分为试验组和对照组,每组30例,试验组口服甘草酸二铵胶囊联合双环醇片治疗,对照组口服甘草酸二铵胶囊治疗,观察两组患者治疗前后肝功能血清生化指标、免疫学指标、肝纤维化程度变化情况及综合疗效的组内和组间差异,并记录不良反应。结果与基线期相比,治疗24周后,试验组和对照组患者血清ALT分别为(146.40±29.57)、(34.28±10.91)与(140.89±32.67)、(51.29±17.67);AST分别为(131.07±37.19)、(35.29±10.16)与(122.54±41.50)、(46.70±15.79);此两项指标的改善试验组效果更为显著(P<0.01)。TBIL分别为(17.62±6.38)、(11.03±3.89)与(18.89±7.84)、(12.11±6.30)(P<0.01);ALP分别为(102.94±39.72)、(68.10±26.24)与(109.21±42.72)、(72.23±28.36)(P<0.01)。试验组和对照组显效率分别为70.13%和47.50%,总有效率分别为85.37%和65.00%,两组差异均有统计学意义(P<0.05)。治疗后两组患者免疫学指标γ-球蛋白分别为(16.94±1.04)和(16.69±0.97),IgG水平分别为(26.65±2.89)和(26.96±3.23),与治疗前相比均明显降低(P<0.01),两组差异无统计学意义(P>0.05);两组患者瞬时弹性记录仪观察肝纤维化程度治疗后较治疗前未进展(P>0.05)。两组不良反应发生率差异无统计学意义(P>0.05)。结论甘草酸二铵胶囊联合双环醇片治疗轻症自身免疫性肝炎与单用甘草酸二铵胶囊比较,近期疗效更好且不增加甘草酸类制剂相关不良反应发生率。

Objective To observe the clinical effect and safety of diammonium glycyrrhetate plus bicyclol in the treatment of mild autoimmune hepatitis.Methods 60 patients meeting the inclusion criteria were equally randomized to therapy group treated with diammonium glycyrrhetate capsuls （150 mg,t.i.d）plus bicyclol tablets（25mg,t.i.d）and control group treated with diammonium glycyrrhetate capsules （150 mg,t.i.d）consecutive 24 weeks.The treatment is based upon comparing the index of serum biochemistry,immunology and liver fibrosis and the difference between inside group and outside group of comprehensive treatment effects,and observing and recording the adverse reactions after using medicine.Results At baseline and 24 week after treatment,ALT were （146.40 ± 29.57 ）and （34.28 ± 10.91 ）VS （140.89±32.67）and（51 .29±17.67）,AST were（131 .07±37.19）and（35.29±10.16）VS（122.54±41 .50）and（46.70± 15.79）in the experimental and control groups respectively.And the effects of bicyclol tablets in decreasing plasma ALT , AST levelswere better than those of diammoniumglycyrrhizinate capsules （P 〈 0.01 ）.TBIL was （17.62 ± 6.38 ）and （11 .03±3.89）（P 〈0.01）VS（18.89 ±7.84）and（12.11 ±6.30）（P 〈0.01 ）;ALP were（102.94 ±39.72）and（68.10 ± 26.24）（P 〈0.01）VS（109.21 ±42.72）and（72.23±28.36）（P 〈0.01）.The significant efficiency rate of treatment group＆amp;nbsp;（70.13%）was better than that of control group （47.50%）（P 〈0.05 ）.The total effective rate of treatment group （85.37%）was better than that of control group （65.00%）（P 〈0.05 ）.There was no obvious improvement of liver fibrosis stageobserved by fibroscan after treatment （P 〉0.05 ）.after treatment,immunology index of patients in two groups all decreased （P 〈0.01）,γ-globin were（16.94±1 .04）and（16.69±0.97）,IgG were（26.65 ±2.89）and（26.96± 3.23 ）respectively.The differences between the two groups have no statistical significance （P 〉0.05 ）.Conclusion Treatment with diammonium glycyrrhetate capsuls plus bicyclol tablets was a more effective and safer remedy than diammonium glycyrrhetate in treating mild AIH.