苦参素制剂治疗慢性乙型肝炎的临床试验

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303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53.3%～58.3%,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＜0.01.对HBV DNA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＜0.01)和硫普罗宁组(P＜0.05), 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＜0.01).停药6个月后,苦参素各治疗组HBV DNA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＜0.01).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HBV DNA的阴转率,停药后仍有持久的疗效.

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

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.