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目的:观察中药补肾冲剂联合苦参素治疗中医辨证为肝肾亏虚兼湿热型慢性乙型肝炎患者的临床抗病毒疗效。方法:在6所医院进行多中心、分层随机平行对照研究,选取乙肝病毒主要复制指标HBV DNA和/或HBeAg阳性且中医辨证为肝肾亏虚兼湿热型慢性乙型肝炎患者共247例,补肾冲剂+苦参素治疗组126例,拉米夫定对照组121例,疗程1年;观察两组患者血清HBeAg、HBV DNA的阴转率和HBV DNA滴度变化及肝功能、症状体征变化情况。结果:在1年疗程结束时,治疗组HBVDNA阴转率达43.7%(55/126)较对照组(64.5%)低(P<0.05);但HBeAg阴转率(40.9%)和HBeAg/抗HBe血清转换率(30%)明显高于对照组(23.4%和13.5%)(P<0.05);ALT复常率(86.4%)较对照组(62.7%)高(P<0.05);肝功能指标改善(P<0.01或P<0.05),其中ALB、GLB的改善较对照组明显(P<0.01或P<0.05);症状改善以头晕、腰酸、胁肋胀痛、尿黄、纳呆最为显著,明显优于对照组(P<0.01);部分应答率(34.1%)明显高于对照组(21.5%)(P<0.05)。结论:补肾冲剂联合苦参素对中医辨证为肝肾亏虚兼湿热型慢性乙型肝炎有较理想的近期抗病毒疗效;能有效抑制HBV复制,改善肝功能及症状体征。
Objective: To observe the clinical antiviral effect of Chinese herb Bushen granule combined with oxymatrine in the treatment of TCM syndrome differentiation of liver and kidney deficiency and damp-heat chronic hepatitis B patients. Methods: A multicenter, stratified and randomized parallel controlled study was conducted in 6 hospitals. A total of 247 patients with hepatitis B virus deficiency and damp-heat type chronic hepatitis B were enrolled in this study. HBV DNA and / 126 cases of Bushen Granule and Oxymatrine treatment group and 121 cases of lamivudine control group for 1 year. The changes of serum HBeAg, HBV DNA negative rate and HBV DNA titer, liver function, symptoms and signs were observed in two groups Happening. Results: At the end of one year, HBVDNA negative rate in the treatment group was 43.7% (55/126), lower than that in the control group (64.5%) (P <0.05); but HBeAg negative conversion rate (40.9%) and HBeAg / HBe seroconversion rate (30%) was significantly higher than that of the control group (23.4% vs 13.5%) (P <0.05); the rate of ALT recovery was 86.4% higher than that of the control group (62.7% (P <0.01 or P <0.05). The improvement of ALB and GLB was more obvious than that of the control group (P <0.01 or P <0.05). The symptoms were dizziness, lumbar acid, flank pain, urinary yellow, (P <0.01). The partial response rate (34.1%) was significantly higher than that of the control group (21.5%) (P <0.05). Conclusion: Bushen granule combined with oxymatrine has better anti-virus effect on TCM syndrome differentiation of liver-kidney deficiency and damp-heat type of chronic hepatitis B. It can effectively inhibit HBV replication and improve liver function and symptoms and signs.