五酯胶囊治疗慢性乙型肝炎患者顽固性谷丙转氨酶升高临床研究

Clinical Study on Five Ester Capsules for Refractory Alanine Aminotransferase Elevation in Patients with Chronic Hepatitis B

目的:观察五酯胶囊治疗慢性乙型肝炎顽固性谷丙转氨酶(ALT)升高的患者的临床疗效。方法:将160例慢性乙型肝炎顽固性ALT升高患者随机分为观察组90例、对照组50例和安慰剂组20例,观察组予以五酯胶囊治疗,对照组予以甘草酸二胺胶囊治疗,安慰剂组在对照组的基础上加用安慰剂,3组同时予以常规抗病毒治疗,疗程均为3个月;观察比较3组临床疗效,ALT复常率、反跳率及ALT变化情况。结果:总有效率观察组为88.89%,安慰剂组为75.00%,对照组为68.00%;观察组总有效率高于安慰剂组及对照组(P <0.05),安慰剂组与对照组则疗效相当(P> 0.05)。观察组ALT复常率为91.11%,高于安慰剂组的80.00%及对照组的72.00%,差异有统计学意义(P <0.05);安慰剂组与对照组的ALT复常率则差别不大(P> 0.05)。观察组ALT反跳率为18.29%,低于安慰剂组的25.00%及对照组的33.33%,差异有统计学意义(P <0.05);安慰剂组与对照组的ALT反跳率则差别不大(P> 0.05)。治疗后,3组ALT值均较治疗前明显下降(P <0.05);但3组间两两比较,差异均无统计学意义(P> 0.05)。结论:五酯胶囊能有效降低患者血清ALT值,对于治疗慢性乙型肝炎顽固性ALT升高患者具有良好疗效。

Objective:To observe the clinical effect of five ester capsules for refractory ALT elevation in patients with chronic hepatitis B.Methods:Divided 160 cases of chronic hepatitis B patients with refractory ALT elevation randomly into the observation group with 90 cases,the control group with 50 cases and the placebo group with 20 cases.The observation group was treated with five ester capsules;the control group was given drug therapy with diammonium glycyrrhizinate capsules;and the placebo group was additionally given placebo.All the three groups received routine antiviral treatment in hospital at the same time for three months.Observed and compared the clinical effect,normalization rate,rebound rate and ALT changes in the three groups.Results:The total effective rate was 88.89%in the observation group,75.00%in the placebo group and 68.00%in the control group;the total effective rate in the observation group was higher than that in the placebo group and the control group(P<0.05),and the efficacy in the placebo group was equivalent to that in the control group(P>0.05).The normalization rate of ALT in the observation group was 91.11%,being higher than that of 80.00%in the placebo group and 72.00%in the control group,difference being significant(P<0.05).There was no significant difference being found in normalization rate of ALT between the placebo group and the control group(P>0.05).The rebound rate of ALT in the observation group was 18.29%,being lower than that of 25.00%in the placebo group and 33.33%in the control group,difference being significant(P<0.05);there was no significant difference being found in rebound rate of ALT between the placebo group and the control group(P>0.05).After treatment,ALT values in the three groups were decreased significantly when compared with those before treatment(P<0.05).However,no significant differences were found in the comparison between any two groups among the three groups(P>0.05).Conclusion:The application of five ester capsules can effectively reduce serum ALT values and has good effect in the treatment for refractory ALT elevation in patients with chronic hepatitis B.