α-干扰素联合柴胡疏肝散治疗慢性乙型肝炎的临床观察及对TNF-α、IL-6的影响

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 factor α，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-α 24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。

Efficacy of CHSGS combined with interferon-α against chronic hepatitis B and effects on serum TNF-α, IL-6

OBJECTIVE To explore the efficacy of Chaihu Shugan San (CHSGS) or diammonium glycyrrhizinate enteric-coated capsules combined with interferon α (interferon α, IFN-α) against chronic hepatitis B (CHB).METHODS Totally 524 cases of CHB were randomly divided into 3 groups, including single drug group (174 cases), traditional Chinese medicine (TCM) combined group (174 cases) and western medicine combined group (176 cases). Patients were treated with IFN-α in single drug treatment group, with IFN-α based on CHSGS in traditional Chinese medicine combined group, with IFN-α treatment based on the licorice diammonium glycyrrhizinate enteric-coated capsules in western medicine combined group. The course of treatment was 24 weeks. Symptom score, the curative effect of TCM, ALT level, HBV DNA quantitation, antiviral treatment response were observed in three groups before and after treatment, changes of TNF-α and IL-6 levels were observed before treatment, after 8 weeks and 24 weeks of treatment.RESULTS After 24 weeks of treatment, the symptoms improved most obviously in TCM combined group and least in single drug group (P<0.01, P<0.05). After treatment, the complete response rate was highest in TCM combined group and the lowest in single drug group (P<0.05). After 8 weeks of treatment, the levels of TNF-α and IL-6 were increased in TCM combined group and in single drug group but decreased in western medicine combined group, the levels of TNF-α and IL-6 were decreased in TCM combined treatment group and single drug group in 8 and 24 weeks of treatment.CONCLUSION IFN-α combined with CHSGS or CHB can improve the symptoms of the patients, increase the antiviral efficacy, and it is worthy to be recommended. Combination with diammonium glycyrrhizinate enteric-coated capsules can reduce interferon antiviral efficacy, and should not be recommended.