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研究健脾益肾养肝方联合聚乙二醇干扰素治疗HBe Ag阳性慢性乙肝(HP-HBV)的临床疗效。选择2012年6月—2014年12月接受治疗的HP-HBV患者126例,给予聚乙二醇干扰素-α-2a(或α-2b)治疗24周,按照HBV-DNA水平分为应答组与应答不佳组,应答不佳组依据随机数字表法平均分为对照组与试验组,对照组继续单纯使用聚乙二醇干扰素-α-2a(或α-2b)治疗,试验组采用聚乙二醇干扰素-α-2a(或α-2b)联合健脾益肾养肝方治疗。观察各组治疗前,治疗24周HBe Ag,ALT及HBV-DNA水平变化;治疗48周病毒学应答、血清学应答及生化学应答,临床症状及体征积分,不良反应等指标。结果显示,治疗24周后,应答组HBe Ag,ALT,HBV-DNA水平显著优于应答不佳组(P<0.05)。治疗48周,应答组、应答不佳组HBVDNA阴转率、HBe Ag阴转率存在统计学差异(P<0.05)。试验组HBV-DNA阴转率、HBe Ag阴转率显著优于对照组(P<0.05)。试验组治疗48周临床症状及体征积分显著低于对照组(P<0.05),试验组不良反应发生率(0%)显著低于对照组(8.70%)(P<0.05)。表明健脾益肾养肝方联合聚乙二醇干扰素治疗HP-HBV安全有效,值得应用于临床。
To study the clinical efficacy of Jianpi Yishen Yanggan Decoction combined with pegylated interferon in the treatment of HBeAg-positive chronic hepatitis B (HP-HBV). A total of 126 HP-HBV patients treated from June 2012 to December 2014 were selected and treated with peginterferon-α-2a (or α-2b) for 24 weeks. According to HBV-DNA levels, 126 patients were divided into response group And poor response group, poor response group according to random number table method equally divided into control group and experimental group, the control group continued to use simple pegylated interferon-α-2a (or α-2b) treatment, the experimental group used Pegylated interferon-α-2a (or α-2b) combined with spleen and kidney Yanggan Fang treatment. The levels of HBe Ag, ALT and HBV-DNA in each group before and 24 weeks of treatment were observed. The virological response, serological and biochemical responses, clinical symptoms and signs, and adverse reactions were observed 48 weeks after treatment. The results showed that after 24 weeks of treatment, HBeAg, ALT and HBV-DNA levels in response group were significantly better than those in poor response group (P <0.05). After 48 weeks treatment, HBVDNA negative rate and HBeAg negative rate in response group and poor response group were significantly different (P <0.05). The test group HBV-DNA negative rate, HBe Ag negative conversion rate was significantly better than the control group (P <0.05). The scores of clinical symptoms and signs of test group 48 weeks after treatment were significantly lower than those of control group (P <0.05). The incidence of adverse reactions in test group (0%) was significantly lower than that of control group (8.70%) (P <0.05). It is indicated that the combination of “Jianpi Yishen Yanggan Decoction” and “Pegylated Interferon” in the treatment of HP-HBV is safe and effective and should be applied to clinic.