苦参素制剂治疗慢性乙型肝炎的临床试验

A clinical trial of oxymatrine in treating chronic viral hepatitis type B

目的 验证不同的苦参素制剂治疗慢性乙型肝炎的疗效。方法 采用开放、随机对照法 ,分别用苦参素葡萄糖注射液静脉滴注、苦参素注射液肌肉注射及苦参素胶囊口服与硫普罗宁口服作为对照 ,治疗慢性乙型肝炎病人共 30 3例 ,治疗结束及停药后 6个月追踪随访观察病人。结果 疗程结束时 ,苦参素各组与硫普罗宁组ALT复常率相似 ,停药后随访 6个月 ,苦参素各组ALT复常率仍保持在 5 3 3%～ 5 8 3%,较硫普罗宁组 38 8%为优。HBeAg阴转率 ,停药后随访 6个月 ,苦参素各组达 30 0 %～ 40 9%,均优于硫普罗宁组的 16 7%,P <0 0 1。对HBVDNA的阴转率 ,苦参素静脉滴注组和苦参素肌肉注射组在治疗 2个月时 ,分别为 42 0 %和 32 7%,均优于苦参素口服组 (P <0 0 1)和硫普罗宁组 (P <0 0 5 ) ,治疗 3个月时 ,苦参素口服组上升为 37 6 %,优于硫普罗宁组 (P <0 0 1)。停药 6个月后 ,苦参素各治疗组HBVDNA阴转率继续上升 ,达 39 2 %～ 49 5 %,均明显优于硫普罗宁组的 18 4 %(P <0 0 1)。结论 苦参素各治疗组可以改善慢性乙型肝炎病人的肝功能 ,提高HBeAg和HBVDNA的阴转率 ,停药后仍有持久的疗效。

Objective To investigate the therapeutic effect of oxymatrine on chronic viral hepatitis type B. Methods 303 patients were randomly allocated either to a treatment group or a control group. The treatment group consisted of 253 patients treated with intravenous or intra-muscular injection of oxymatrine and oral oxymatrine capsule. Oral tiopronin was used in the control group. Results At the end of treatment, the rate of normal ALT was similar among the different groups. The rate of normal ALT was 53.3%～58.3% in the three oxymatrine groups six months after the end of treatment. It was higher than that of the tiopronin group (P<0.05). After a follow up of six months, the rate of negative HBeAg was 30.0%～40.9% in the three oxymatrine groups. It was higher than that of the tiopronin group(16.7%). The rate of negative HBV DNA was 39.2%～49.5% in the three oxymatrine groups. It was also higher than that of the tiopronin group. Conclusion Oxymatrine can improve the liver function and increase the negative rate of HBeAg and HBV DNA in the patients with chronic hepatitis B. The therapeutic effect of oxymatrine will persist after the cessation of administration.