补肾冲剂和苦参素联合抗病毒治疗慢性乙型肝炎多中心临床研究

Clinical Study of Antiviral Therapy of Kidney-Invigorating Granule Combined With Marine Injection to Treat Chronic Hepatitis B

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 evaluate the antiviral efficiency of Kidney-invigorating Granule combined with Marine Injection to treat chronic hepatitis B differentiated as syndrome type of liver-kidney insufficiency accompanied by dampness - heat retention according to Traditional Chinese Medicine（TCM） theory. Methods：This muhicentre, randomized and comparative study was completed in 6 hospitals. A total of 247patients who were HBsAg, HBVDNA and/or HBeAg positive and differentiated as TCM syndrome pattern of liver-kidney insufficiency accompanied by dampness-heat retention were enrolled. They were randomized to receive either Kidney - invigorating Granule 20g daily combined with Marine Injection 400mg daily （ the treated group ） （ n = 126 ） or lamivudine 100mg daily （ the control group） （ n = 121 ） for the first 6 months. Thereafter the former treated with Kidney-invigorating Granule and the latter continue to treat with lamivudine for a total 1 year. Rate of HBeAg and HBVDNA loss, HBVDNA load, indicators of liver function and symptoms and signs were observed in all patients. Results：At the end of 1 year duration 43. 7% of Kidneyinvigorating Granule and Marine Injection recipients had undetectable serum HBVDNA（ 〈 5×10^3 copies/ml） , compared with 64. 5% of those in the control group P 〈 0. 05 ）. Rate of HBeAg loss and HBeAg/anti - HBe seroconversion were 40. 9% verse 30% （（ P 〈 0. 05）,23.4% verse 13.5% （P 〈 0. 05 ）respectively. ALT levels were remained in normal ranges in 86. 4% and 62.7% of whose ALT were abnormal before treatment in the treated group and control group respectively（ P 〈 0. 05 ）. Combination therapy of Kidney-invigorating Granule and Marine Injection contributed to improvement of Indicators of liver func- tion esp. ALB and GLB, which improved significantly than lamivudine therapy. Such symptoms as swirl, achingwaist, distending pain of hypochondria, poor appetite and yellowish urine were alleviated evidently by combination therapy of Kidney- invigorating Granule with Marine Injection which superior to lamivudine（P 〈0.05）. By the end of 1 year,34. 1% and 21.5% of patients in the treated group and the control group respectively achieved serum loss of HBVDNA and HBeAg accompanied by ALT keeping normal ,there was difference between two groups （P 〈0.05）. Conclusion：HBV replication suppressing and clinical improvement could be obtained after 1-year combination therapy of Kidney-invigorating Granule and Marine Injection of good tolerance and safety.