氧化苦参碱治疗慢性重度乙型肝炎的临床研究

Therapeutic Effect of Oxymatrine on Patients with Severe Chronic Hepatitis B

【目的】观察氧化苦参碱注射液治疗慢性重度乙型肝炎(CHB)的临床疗效。【方法】将80例CHB患者分为两组:治疗组40例,用氧化苦参碱注射液600mg静脉滴注;对照组40例,以古拉定1.2g静脉滴注,疗程8周,治疗前后检测肝功能、乙型肝炎病毒复制标志物HBV DNA和HBeAg,同时观察患者的症状、体征的变化及药物的不良反应。【结果】HBV复制指标HBeAg滴度、HBV DNA拷贝数下降水平治疗组明显高于对照组,有显著性差异(P<0.05);HBV复制指标HBeAg、HBV DNA的转阴率治疗组明显高于对照组,有显著性差异(P<0.05)。治疗结束后AST、ALT、TBil治疗组明显低于对照组,有显著性差异(P<0.05)。【结论】氧化苦参碱对乙型肝炎病毒有抑制作用,是治疗CHB较为有效的中药制剂。

[Objective] To observe the clinical effect and adverse effect of oxymatrine in treating patients with severe chronic hepatitis B （CHB）. [Methods] Eighty Patients with CHB were randomly divided into two groups. The control group （ n =40） was only received liver-protective drugs and supportive therapy, while the treatment group （ n = 40） was administrated oxymatrine plus liver-protective drugs and supportive therapy for 8 weeks. Liver function and hepatitis B virus （HBV） replication markers such as HBeAg and HBV DNA were detected before and after treatment. The symptom, physical sign and adverse effect were observed. [Results] The titer of HBeAg and copies of HBV DNA in the treatment group were significantly lower than those in the control group（ P 〈0.05）. The negative-conversion rate of HBV replication markers was significantly different between the control group and the treatment group（28.6% vs 5.3% ,12.5.0% vs 2.50%, P 〈0.05）. The levels of AST, ALT and TBil were significantly lower in the treatment group than those in the control group（ P 〈0.05）. The adverse reaction was only mild gastrointestinal reaction. [Conclusion] Oxymatrine can inhibit HBV replication and improve liver function. It is an effective Chinese drug preparation for the treatment of severe CHB and can increase cure rate.