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目的:探讨柴胡疏肝散、甘草酸二铵肠溶胶囊对α-干扰素(interferon-alpha,IFN-α)治疗慢性乙型肝炎(chronic hepatitis B,CHB)疗效的观察及对肿瘤坏死因子-α(tumor necrosis factorα,TNF-α)、白细胞介素-6(interleukin-6,IL-6)水平的影响。方法:524例慢性乙型肝炎,按随机数字表法随机分为单药治疗组174例,联合中药治疗组174例,联合西药治疗组176例。单药治疗组采用IFN-α治疗24周;联合中药治疗组在IFN-α治疗基础上,采用柴胡疏肝散口服,每日1剂,疗程24周;联合西药治疗组在IFN-α治疗基础上,采用甘草酸二铵肠溶胶囊150-mg tid口服,疗程24周。观察3组治疗前后的症状积分改变情况、中医症状疗效、ALT水平、HBV DNA定量、抗病毒治疗应答及治疗前、治疗8周、治疗24周的TNF-α、IL-6水平的变化。结果:治疗24周后,联合中药治疗组症状积分改善程度最明显、中医症状疗效总有效率最高,联合西药治疗组次之,而单药治疗组最低(P<0.01,P<0.05)。完成IFN-α24周治疗后,联合中药治疗组ALT改善程度、HBV DNA定量下降程度及完全应答率最高,无应答率最低,单药治疗组次之,而联合西药治疗组最低(P<0.05);治疗8周后联合中药治疗组及单药治疗组TNF-α、IL-6水平较治疗前升高(P<0.05),联合西药治疗组TNF-α、IL-6水平较治疗前下降(P<0.01),治疗24周后联合中药治疗组及单药治疗组TNF-α、IL-6水平较治疗8周明显下降(P<0.01),联合西药治疗组TNF-α、IL-6水平较治疗8周时无明显下降(P>0.05)。结论:INF-α联合柴胡疏肝散治疗慢性乙型肝炎可改善患者症状,增加INF-α抗病毒疗效,值得推荐联用,而联合甘草酸二铵肠溶胶囊治疗可降低INF-α抗病毒疗效,不推荐联合使用,INF-α及柴胡疏肝散均可以通过上调TNF-α、IL-6水平通过免疫激活来清除病毒,二者联用可起到协同作用。
Objective: To investigate the curative effect of Chaihu Shugan San and diammonium glycyrrhizinate enteric-coated capsules on the treatment of chronic hepatitis B (CHB) by interferon-alpha (IFN-α) and the effect on the tumor necrosis factor α (tumor necrosis factorα, interleukin-6, interleukin-6) Methods: A total of 524 cases of chronic hepatitis B were randomly divided into single-drug treatment group (174 cases), combined TCM treatment group (174 cases) and western medicine treatment group (176 cases). The single drug treatment group was treated with IFN-α for 24 weeks. On the basis of IFN-α treatment, the combined traditional Chinese medicine treatment group was given Chaihu Shugan San oral once a day for 24 weeks. In combination with western medicine treatment group, IFN- Based on the use of diammonium glycyrrhizinate enteric-coated capsules 150-mg tid oral treatment for 24 weeks. The changes of symptom scores, TCM symptom, ALT level, HBV DNA, antiviral treatment response and the levels of TNF-α and IL-6 in the three groups before and after treatment for 8 weeks and 24 weeks were observed. Results: After 24 weeks of treatment, symptom score of combined Chinese medicine group was the most obvious. The total effective rate of symptoms of traditional Chinese medicine was the highest, followed by western medicine group, and lowest in monotherapy group (P <0.01, P <0.05). After 24 weeks of IFN-α treatment, the improvement of ALT, the quantitative decrease of HBV DNA and the complete response rate were the highest in the combined Chinese medicine group with the lowest response rate, followed by monotherapy group and the lowest in combined western medicine group (P <0.05) ; After 8 weeks of treatment, the levels of TNF-α and IL-6 in the combined traditional Chinese medicine group and monotherapy group were significantly higher than those before treatment (P <0.05), and the levels of TNF-α and IL-6 in the western medicine group were lower than those before treatment (P <0.01). After 24 weeks of treatment, the levels of TNF-α and IL-6 in the combined traditional Chinese medicine group and monotherapy group were significantly lower than those in the 8th week (P <0.01) Compared with 8 weeks after treatment, there was no significant decrease (P> 0.05). Conclusion: The treatment of chronic hepatitis B with INF-α and Chaihu Shugan Powder can improve the symptoms and increase the antiviral effect of INF-α, which is recommended for combination therapy. Combined with diammonium glycyrrhizinate enteric-coated capsules can reduce INF-α Virus efficacy, not recommended for combination, INF-α and Chaihu Shuguansan can raise the level of TNF-α, IL-6 by immune activation to clear the virus, the two can play a synergistic effect.