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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 observe the efficacy and safety of oxymatrine (oxymatrine) capsule in the treatment of chronic hepatitis B (CHB). Methods A multicenter, randomized, double-blind, placebo-based and placebo-controlled clinical trial was designed. Two hundred and sixteen patients with chronic hepatitis B were randomly assigned to the oxymatrine capsule group (108 patients) Injection group (36 cases) and blank control group (72 cases), completed 24 weeks of treatment. Before and after treatment to observe the clinical symptoms, liver function, serum hepatitis B virus markers and adverse reactions. Results In all patients, 6 cases were dropped off and 11 cases did not meet the inclusion criteria. A total of 199 patients were enrolled in the curative effect statistics, including 102 cases in capsule group, 30 cases in injection group and 67 cases in blank control group. Oxymatrine capsule treatment of chronic hepatitis B, the HBVDNA and HBeAg negative conversion rates were 3 8.61% and 3.91%, ALT normalization rate was 76.47%; Oxymatrine injection group HBVDNA and HBeAg negative conversion rates were 43 .3 3% and 39.29% respectively. The ALT normalization rate was 83.33%, while the blank control group HBVDNA and HBeAg negative conversion rates were 7.46% and 6.45%, ALT normalization rate was 40.0%. After treatment, the complete response rate and partial response rate in the capsule group were respectively 4.51% and 5 7.84%, 33.33% and 50.0% in the injection group and 2.99% and 41.79% in the control group, respectively , And there was no significant difference between oxymatrine capsule group and oxymatrine injection group, but it was significantly higher than that of the control group (P <0.05). The incidence of adverse reactions of matrine capsule group, injection group and blank control group were 7.77%, 6.67% and 8.82 %, No serious adverse reactions occurred. The incidence of adverse reactions among the three groups without?