氧化苦参碱联合拉米夫定治疗慢性乙型肝炎临床观察

Clinical Study on Oxymatrine/Lamivudine Combination in the Treatment of Chronic Hepatitis B

目的观察分析氧化苦参碱联合拉米夫定治疗慢性乙型肝炎(CHB)的疗效和安全性,探讨联合治疗的协同作用机理。方法将122例HBsAg,HBeAg阳性或HBeAg阴性,而HBV DNA阳性的CHB患者随机分为三个组:①氧化苦参碱联合拉米夫定组;②单用干扰素组;③单用拉米夫定组,疗程均为6个月。观察各组肝功能和乙型肝炎病毒标志(HBVM)的变化情况和不良反应。结果治疗结束时三组临床症状均有不同程度改善。联合组肝功复常率为89.3%。而干扰素组和拉米夫定组分别为65.4%和60.9%。三组有显著性差异;联合组HBeAg阴转率为68.8%,HBV DNA阴转率为82.9%,干扰素组分别为44%和61.9%,拉米夫定组分别为38.1%和59.1%,三组有显著性差异。干扰素组与拉米夫定组均无显著性差异。治疗中干扰素组出现了相关不良反应,其余两组中未见不良反应。结论氧化苦参碱联合拉米夫定治疗CHB有协同抗病毒,保肝等作用。明显改善肝功能,优于单用干扰素组或单用拉米夫定组,提高了疗效,且安全经济。

Objective To evaluate the efficacy and safety of oxyrnatrine/lamivudine combination in the treatment of chronic hepatitis B （CHB） and discuss the mechanism.Methods A total of 122 patients with HBsAg, positive HbeAg or negative HbeAg were studied and all of the CHB patients with positive HBV DNA were divided randomly into three groups： 1. Oxymatrine/lamivudine combination group; 2. Group using IFN-a only; 3. Group using lmivudine only. The observation period of each group was 6 months. The adverse events and changes of liver function and hepatitis B vires markers of each group were observed. Results After the treatment, clinical symptoms of three groups were improved more or less. In the combination group, 89.3 % of cases liver function became normal, and the IFN-α group and the lamivudine group were 65.4% and 60.9% respectively. There was significant difference among the three groups. In the combination group, HBeAg in 68.8 % of cases and HBV DNA in 82.9 % became negative. In the IFN-α group these figures were 44% and 61.9% respectively and the lamivudine group were 38.1% and 59.1% .There was significant difference among the three groups. There was no significant difference between the IFN-α grroup and the lamivudine group. During the treatment, adverse event was found in the IFN-α group, but not seen in the other two groups. Conclusions Oxymatrine/lamivudine combination is effective in the trearment of CHB through its cooperative antiviml property and its protection to the liver. The method can improve the liver function effectively and the efficacy is better than the IFN-α group and the lamivudine group. Oxymatrine/lamivudine combination in the treatment of chronic hepatitis B is safe, effective and economic.