补肾健脾方对HBeAg阳性乙肝病毒携带者的免疫调节作用

目的：评价补肾健脾方对HBeAg阳性乙肝病毒携带者血清细胞因子的调节作用。方法：采用多中心、随机、双盲、对照的研究方法。400例HBeAg阳性乙肝病毒携带者随机分为治疗组和对照组，分别给予补肾健脾方、安慰剂治疗52周。观察治疗前后血清细胞因子IL-2、IL-4、IL-10、IFN-γ、TNF-α水平及HBV DNA载量的变化。结果：治疗52周后，补肾健脾方组患者的血清细胞因子IL-2和IFN-γ显著上升，TNF-α、IL-4和IL-10则明显下降（P<0.01）；治疗前后的各细胞因子差值比较，均优于安慰剂对照组（P<0.01）；而血清HBV DNA载量较基线下降>1 log10,>2 log10,>3 log10比例均显著高于安慰剂对照组（P<0.01）。结论：补肾健脾方通过调节Th1/Th2型细胞因子水平，打破HBV感染的免疫耐受状态，实现对HBV复制的抑制作用。

Immunomodulatory effect of the Bushen Jianpi recipe on HBeAg-positive hepatitis B virus carriers

Objective： To estimate the modulatory effect ofBushen Jianpi recipe on serum cytokines in HBeAg-positive hepatitis B virus carriers. Methods： With the multi-center, randomized, double-blinded and controlled methods, 400 cases of were randomly assigned to treated group and control group. During the 52-week treatments, Bushen Jianpi recipe was applied in treated group and placebo was adopted in control group. The serum cytokine levels, including IL-2, IL-4, IL-10, IFN-γ, and TNF-α, and HBV DNA level were detected pre-treatment and post-treatment in all patients. Results： After the 52-week treatments, in the Bushen Jianpi recipe treated group, the serum levels of IL-2 and IFN-γ were markedly increased, while the serum levels of TNF-a, IL-4 and IL-10 were obviously decreased （P〈0.01）. The variation of each cytokine level pre-treatment and post-treatment in the Bushen Jianpi recipe treated group was significantly different from that in the placebo control group （P〈0.01）. The proportions of patients in the Bushen Jianpi recipe treated group in whom serum HBV DNA levels decreased from the baseline by more than 1 log10, 2 lOgl0, 3 log10 were significantly higher than those in the placebo control group（P〈0.01）. Conclusion： Bushen Jianpi recipe breaks the immunological tolerance of hepatitis B virus infection by modulating the level of Thl/Th2 type cytokines, to achieve the inhibition for HBV replication.