氧化苦参碱治疗慢性乙型肝炎的随机双盲对照多中心研究

目的 观察氧化苦参碱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、安慰剂对照设计的临床试验，选择慢性乙型肝炎患者144例，随机分为氧化苦参碱胶囊组72例和空白对照组72例完成52周治疗并随访12周。治疗前后及停药12周后观察患者临床症状、肝功能、血清乙型肝炎病毒(HBV)标志物和不良反应等。结果 所有入组患者中脱落和不符合入选标准剔除共14例，故共有130例患者纳入疗效统计，其中氧化苦参碱胶囊组65例，空白对照组65例。氧化苦参碱胶囊组治疗慢性乙型肝炎52周其HBVDNA和乙型肝炎e抗原(HBeAg)阴转率分别为43．08％(28／65)和33．33％(20／60)，丙氨酸氨基转移酶(ALT)复常率为70．77％(46／65)；空白对照组HBV DNA和HBeAg阴转率分别为12．31％(8／65)和3．33％(2／60)，ALT复常率为39．68％(25／63)。治疗后完全反应率．部分反应率和无反应率胶囊组分别为23．08％(15／65)，58．46％(38／65)和18．46％(12／65);而对照组分别为3．08％(2／65)、44．62％(29／65)和52．31％(34／65)。两组间比较胶囊组均明显高于对照组(QCMH=21．02，P=0．001)。氧化苦参碱胶囊组治疗慢性乙型肝炎停药12周后其HBV DNA和HBeAg阴转率分别为41．54％(27／65)和23．33％(14／60)，ALT复常率为60．00％(39／65);空白对照组HBV DNA和HBeAg阴转率分别为3．08％(2／65)和1．67％(1／60)，ALT复常率为31．75％(20／63)。完全反应率、部分反应率和无反应率胶囊组分别为21．54％(14／65)、47．69％(31／65)和30．77％(20／65)，而对照组分别为0，41．54％(27／65)和58．46％(38／65)，两组间比较胶囊组均明显高于对照组(QCMH=15．22，P=0．001)。氧化苦参碱胶囊组有5例(7．69％)发生不良反应，空白对照组有4例(6．15％)发生不良反应，主要表现为恶心、乏力、皮疹、上腹不适和口苦，均为轻，中度，无严重不良反应发生，不良反应发生率两组间比较差异无显著性。结论 氧化苦参碱胶囊是治疗慢性乙型肝炎有效，安全的药物。

Oxymatrine in the treatment of chronic hepatitis B for one year:a multicenter random double-blind placebo-controlled trial

OBJECTIVE: To evaluate the efficacy and safety of oxymatrine in the treatment of chronic hepatitis B. METHODS: A multicenter randomized double-blind placebo-controlled trial was conducted. A total of 144 patients with chronic hepatitis B entered the study for 52 weeks; of them 72 received oxymatrine, and 72 received a placebo. Before and after the treatment, clinical symptoms, liver function, serum hepatitis B virus markers, and adverse drug reactions were observed. RESULTS: In 144 patients, 14 were dropped and excluded due to inconsistencies in the included standard. Therefore, the efficacy and safety of 130 patients were analyzed. After being treated for 52 weeks, 70.77% of the patients in the study group had a normal ALT level, and in 43.08% and 33.33% their HBV DNA and HBeAg became negative. In the placebo group, 39.68% had normal ALT level, and 12.31% and 3.33% had their HBV DNA and HBeAg become negative. The rates of complete response and partial response in the oxymatrine group were 23.08% and 58.46%, and in the placebo group they were 3.08% and 44.62%. They were significantly higher in the oxymatrine group than in the placebo group. In the oxymatrine treated patients, 12 weeks after its withdrawal, 60.00% had a normal ALT level, 41.54% and 23.33% had both HBV DNA and HBeAg negative. In the placebo group, 31.75% had a normal ALT level, 3.08% and 1.67% had both HBV DNA and HBeAg negative. The rates of complete response and partial response in the oxymatrine group were 21.54% and 47.69%, and in the placebo group they were 0 and 41.54%. They were significantly higher in the study group than in the placebo group. The adverse reaction rates of oxymatrine in the study and the placebo group were 7.69% and 6.15%, respectively, but there was no statistical significant difference between them. CONCLUSION: Oxymatrine is an effective and safe agent for the treatment of chronic hepatitis B.