中药治疗慢性乙型肝炎肝郁脾虚证临床研究

Chronic hepatitis B with TCM syndrome of “Depression of Liver-Energy and Asthenia of Spleen” treated by decoction of TCM

关键词:  慢性乙型肝炎  拉米夫定  肝郁脾虚

Key words:  chronic hepatitis B  lamivudine  Depression of Liver-energy and Asthenia of Spleen

摘要:

［目的］观察中药治疗肝郁脾虚型慢性乙型肝炎的疗效。［方法］采用两中心随机对照研究的方法，治疗组84例接受疏肝健脾解毒汤加减治疗，汤剂1剂/d；对照组40例接受LAM治疗，100 mg 1次/d。两组用药疗程均为6个月，随访3个月。观察两组患者肝功能、血清HBsAg、HBeAg、HBV-DNA阴转率及症状体征的变化。［结果］在ALT复常率方面，中药治疗组、LAM对照组的ALT复常率随着治疗时间的延长而逐渐增加，但两组差异无显著性意义。在DNA阴转率方面，中药治疗组在治疗过程中与LAM对照组比较差异无显著性意义，但在治疗结束后3个月随访时，中药治疗组的DNA阴转率为81.3%，与LAM对照组的20.0%比较差异有显著性意义（P=0.025）。在治疗过程中，中药治疗组患者出现4例HBsAg阴转（其中1例出现血清学转换），而LAM对照组无HBsAg阴转的病例出现。中药治疗组的证候显效率、总有效率均优于LAM对照组。［结论］疏肝健脾解毒汤加减在促使HBsAg阴转/血清学转换、HBeAg阴转/血清学转换，恢复肝功能、促进HBV DNA阴转、促进患者症状、体征的恢复上均有明显疗效。

Abstract:

［Objective］To observe the efficacy on chronic hepatitis B with the TCM syndrome of " Depression of Liver-energy and Asthenia of Spleen" Treated by Decoction of TCM.［Methods］The two-center randomized controlled study was used. The 84 patients with CHB were assigned to receive Shuganjianpijiedu Decoction as treated group, one dose once daily, while the other 40 patients were received 100 mg of Lamivudine once daily as the comparison group. Patients were treated for 6 months and followed for an additional 3 months. The changes of liver function, negative conversion rate of HBsAg, HBeAg and HBV-DNA, symptoms and physical signs in patients were observed.［Results］No significant difference ALT normalization rate and the negative conversion rate of HBV-DNA were observed between the two groups. At the end of follow-up visit, the proportion of patients treated with Shuganjianpijiedu Decoction with undetectable DNA levels was 81.3% compared with 20.0% for Lamivudine treated patients, the difference between the treated group and the control group was statistically significant (P=0.025). Four patients in the treated group lost HBsAg and one had HBsAg seroconversion, but no patients in the control group did so. The clinical symptoms were improved more significantly in the treated group than those in the control group.［Conclusions］It is effective for Shuganjianpijiedu Decoction treatment in achieving virus loss and seroconversion, improving the liver function, clearing HBV DNA and improving symptoms and signs.