苦参素治疗慢性乙型肝炎临床研究

Clinic Investigation of Oxymatrine for Therapy of Chronic Hepatitis B

目的研究苦参素对肝脏炎症和纤维化的治疗作用及对病毒复制的影响,探索其在慢性乙型肝炎及早期肝硬化治疗中的应用价值。方法75例慢性乙型肝炎及早期肝硬化患者予苦参素注射液400mg肌肉注射,每日1次,3个月为1个疗程,观察记录患者治疗过程中临床症状、体征变化及肝功能恢复情况。每月复查1次肝功能、乙肝病毒标志物及血清肝纤维化指标。结果治疗组在改善症状、体征及恢复肝功能方面优于对照组,但无统计学意义。治疗3个月后,治疗组血清HA、LN、PCⅢ及CL-Ⅳ水平较治疗前显著下降(P<0.01),而对照组患者血清肝纤维化指标在治疗前后无显著差异(P>0.05)。治疗结束时,HBeAg、HBV-DNA的阴转率治疗组和对照组分别为38.67%、37.33%和5.88%、7.35%,两组比较差异有显著性意义(P<0.01)。结论苦参素可明显改善慢性乙型肝炎患者临床症状,显著改善肝功能,具有较强的抗纤维化及抗病毒作用。

Objective To observe the effects of oxymatrine treatment on liver inflammation, fibrosis, and the replication of hepatitis B virus (HBV), for further evaluation of the therapeutic value of oxymatrine on chronic hepatitis B and cirrhosis. Methods 75 patients with chronic hepatitis B or mild cirrhosis were treated with oxymatrine injection, 400mg, QD×90 days. Their symptoms and signs were observed, and liver function, HBV markers, as well as levels of serum markers for liver fibrosis were analyzed. Results Patients received oxymatrine injection recovered more rapidly in improvement of symptoms and signs, normalization of liver function compared with the control, but there is no statistically significant difference. The levels of serum hyaluronic acid (HA), laminin (LN), precollagen type Ⅲ (PCⅢ), and collagen type Ⅳ (CL-Ⅳ) decreased dramatically (P <0.01) in patients treated with oxymatrine injection for 3 months, while it is not the case in control group. In oxymatrine treated patients, 38.67% and 37.33% became negative in HBeAg and in HBV DNA respectively. While in control group, only 5.88% and 7.35% patients became negative in HBeAg and HBV DNA respectively. There is statistically significant difference between two groups (P <0.01). Conclusion Oxymatrine injection is effective in patients with chronic hepatitis B or liver cirrhosis of early stage, in improvement of symptoms and signs, normalization of liver function, and is potent in prevention of liver fibrosis and its anti-virus activity.