氧化苦参碱胶囊治疗慢性乙型病毒性肝炎的随机、双盲、安慰剂对照多中心临床研究(I)

Capsule oxymatrine in the treatment of chronic hepatitis B: A randomized double-blind placebo-controlled multicenter study(I).

目的 观察氧化苦参碱 (苦参素 )胶囊治疗慢性乙型肝炎的疗效及安全性。方法 进行多中心、随机、双盲、安慰剂及阳性药物平行对照设计的临床试验 ,选择慢性乙型病毒性肝炎患者 2 16例 ,随机分配到苦参素胶囊组 (10 8例 )、苦参素针剂组 (3 6例 )和空白对照组 (72例 ) ,完成 2 4周治疗。治疗前后观察临床症状、肝功能、血清乙型肝炎病毒标志物和不良反应等。结果 所有入组患者中脱落 6例 ,不符合入选标准剔除 11例 ,共 199例患者纳入疗效统计 ,其中胶囊组 10 2例 ,针剂组 3 0例 ,空白对照组 67例。苦参素胶囊组治疗慢性乙型肝炎 ,其HBVDNA和HBeAg阴转率分别为 3 8.61%和 3 1.91% ,ALT复常率为 76.47% ;苦参素针剂组HBVDNA和HBeAg阴转率分别为 43 .3 3 %和 3 9.2 9% ,ALT复常率为 83 .3 3 % ,而空白对照组HBVDNA和HBeAg阴转率分别为 7.46%和 6.45 % ,ALT复常率为 40 .0 0 %。治疗后完全反应率和部分反应率胶囊组分别为 2 4.5 1%和 5 7.84% ,针剂组为 3 3 .3 3 %和 5 0 .0 0 % ,而对照组为 2 .99%和41.79% ,苦参素胶囊组与苦参素针剂组相比无显著差异 ,但显著高于对照组 ;苦参素胶囊组、针剂组和空白对照组不良反应发生率分别为 7.77%、6.67%和 8.82 % ,无严重不良反应发生。不良反应发生率 3组间比较无?

Objective To evaluate the efficacy and safety of capsule oxymatrine in the treatment of chronic hepatitis B. Methods A randomized double blind placebo controlled multicenter trial was conducted. Injection oxymatrine was used as positive control drug. A total of 216 patients with chronic hepatitis B entered the study for 24 weeks, 108 in the capsule oxymatrine group,36 in the injection oxymatrine group, and 72 in the placebo group. Before and after treatment, clinical symptoms, liver function, serum hepatitis B virus markers, and adverse events were observed.Results In 216 patients, six dropped off, 11 inconsistent with enrolling requirement were excluded. Altogether in 199 patients, the efficacy and safety were analysed. In the capsule group, 76.47% of cases serum ALT level became normal, 38.61% of cases HBV DNA and 31.9% of cases HBeAg became negative. In the injection group, 83.33% of cases serum ALT level became normal, HBV DNA in 43.35% of cases and HBeAg in 39.29% of cases became negative, respectively. In the placebo group, 40.00% of cases ALT level became normal;HBV DNA in 7.46% of cases and HBeAg in 6.45% became negative. The rates of complete response and partial response in the capsule group were 24.51% and 57.84%,in the injection group were 33.33% and 50.00%, and in the placebo group were 2.99% and 41.79%,respectively.There was no significant difference between the capsule and the injection group. The adverse event in the capsule, the injection and the placebo group were 7.77%, 6.67% and 8.82%, respectively. There was no statistical significant difference between the injection, capsule and the placebo gruop.Conclusions Capsule oxymatrine is an effective and safe agent for the treatment of chronic hepatitis B.