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目的:评估补肾清透方对HBe Ag阳性HBV携带者细胞因子的影响、抗病毒疗效及安全性。方法:选取60例符合肾虚证的HBe Ag阳性慢性乙肝病毒携带者,随机分为治疗组(40例)和对照组(20例),治疗组予以中药补肾清透干预,对照组予以安慰剂干预,疗程均为48周。治疗前及治疗后第48周检测所有入组患者外周血的IL-2、IL-10、TNF-α、IFN-γ、HBe Ag、HBe Ab及HBV-DNA。结果:治疗48周后,治疗组升高血清IL-2、TNF-α、IFN-γ水平的程度高于对照组,两组比较均有统计学差异(P<0.01);治疗组降低IL-10水平的程度也高于对照组,两组比较有统计学差异(P<0.01);治疗组HBe Ag阴转率及HBe Ag/HBe Ab血清转换率均高于对照组,两组比较均有统计学差异(P<0.01);治疗组血清HBV-DNA下降>1 log10、>2 logl0、>3 log10及HBVDNA阴转的例数明显多于对照组,两组比较均有统计学差异(P<0.01)。结论:补肾清透方可改善ASC患者的免疫功能,且有一定抑制HBV的作用,可能与改善T细胞功能有关,安全性良好。
Objective: To evaluate the effect of Bushen Qingtongfang on the cytokines in HBeAg-positive HBV carriers and the anti-virus efficacy and safety. Methods: Sixty HBe Ag positive chronic hepatitis B virus carriers were selected and randomly divided into treatment group (n = 40) and control group (n = 20). The treatment group , Treatment are 48 weeks. The levels of IL-2, IL-10, TNF-α, IFN-γ, HBe Ag, HBe Ab and HBV-DNA in peripheral blood of all the patients were measured before treatment and 48 weeks after treatment. Results: After treatment for 48 weeks, the level of serum IL-2, TNF-α and IFN-γ in the treatment group was higher than that in the control group, the difference was statistically significant (P <0.01) 10 levels were also higher than the control group, the two groups were statistically significant difference (P <0.01); treatment group HBe Ag negative conversion rate and HBe Ag / HBe Ab serum conversion rate were higher than the control group, both groups were compared (P <0.01). Serum levels of HBV DNA in the treatment group were significantly lower than those in the control group (> 1 log10,> 2 logl0,> 3 log10, and HBVDNA) <0.01). Conclusion: Bushen Qingtong Decoction can improve the immune function of patients with ASC, and have a certain inhibition of the role of HBV may be related to the improvement of T cell function, good safety.