补肾冲剂联合苦参素治疗肝肾亏虚兼湿热型慢性乙型肝炎临床研究

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 选取乙肝病毒主要复制指标HBVDNA、HBsAg和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90例，随机分为补肾冲剂加苦参素治疗组（治疗组）49例和拉米夫定对照组（对照组）41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 治疗组HBV DNA阴转率为42．6％（20／47例）与对照组61．0％（25／41例）比较差异无显著性（P〉0．05）；HBeAg阴转率（42．6％）和HBeAg／抗HBe血清转换率（36．2％）明显高于对照组（22．0％和17．0％，P〈0．05）；ALT复常率（74．4％）较对照组（51．4％）高（P〈0．05）；肝功能指标改善（P〈0．05或P〈0．01），其中ALB、GLB的改善较对照组明显（P〈0．01，P〈0．05）；症状改善以头晕、腰酸、胁肋胀痛、尿黄4症最为显著，明显优于对照组（P〈0．01）；部分应答率（29．8％）与对照组（14．6％）比较差异无显著性（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疗效；能有效抑制HBV复制，改善肝功能及症状体征。

Clinical Study on Effect of Bushen Granule Combined with Marine Injection in Treating Chronic Hepatitis B of Gan-shen Deficiency with Damp-Heat Syndrome Type

Objective To evaluate the antiviral efficacy of Bushen Granule (BSG) combined with Marine Injection (MI) in treating patients with chronic hepatitis B of Gan-shen deficiency with Damp-Heat (GSD) syndrome type. Methods A total of 90 patients, who were HBV DNA, HBsAg, and HBeAg positive and of GSDD type, were enrolled, and they were randomly assigned into 2 groups. The 49 patients in the treated group were treated with the combined therapy of BSG and MI and the 41 were administered with lamivudine, the therapeutic course for both groups was 1 year. The negative conversion rate of HBeAg and HBV DNA and the changes in HBV DNA titre, liver function, symptoms and physical signs were observed in the two groups before and after treatment. Results In the treated group, the negative conversion rate of HBV DNA was 42.6% (20/47), insignificantly different to that in the control group (61.0%, 25/41,P>0.05); the negative conversion rate of HBeAg and HBeAg/anti-HBe sero-conversion rate was 42.6% and 36.2%, respectively, significantly higher than those in the control group (22.0% and 17.0%,P<0.05); the ALT normalizing rate was 74.4%, higher than that in the control group (51.4%, P<0.05); the improvement of liver function (ALB and GLB) and clinical symptoms, especially the dizziness, soreness of waist, hypochondrial distending pain, and yellowish urine, were significantly superior to those in the control group(P<0.01 or P<0.05); and the partial response rate was 29.8%, insignificant different to that in the control group (14.6%, P>0.05). Conclusions Combined treatment of BSG and MI has an ideal short-term effect in treating patients with chronic hepatitis B of Gan-shen deficiency with Damp-Heat syndrome type, it can inhibit HBV replication and improve patients' liver function and physical signs.