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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HBV DNA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(Qcmn=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?
Objective To observe the efficacy and safety of oxymatrine capsules in the treatment of chronic hepatitis B patients. Methods A multicenter, randomized, double-blind, placebo-controlled clinical trial was conducted in which 144 patients with chronic hepatitis B were randomly divided into two groups: oxymatrine capsule group (72 cases) and blank control group (72 cases) 12 weeks. Clinical symptoms, liver function, serum hepatitis B virus (HBV) markers and adverse reactions were observed before and after treatment and after 12 weeks of withdrawal. Results A total of 14 patients were excluded from the study and did not meet the inclusion criteria. A total of 130 patients were enrolled in the study. Among them, 65 were in the oxymatrine capsule group and 65 in the blank control group. At 52 weeks of treatment with oxymatrine capsule, HBV DNA and hepatitis B e antigen (HBeAg) negative conversion rates were 43.08% (28/65) and 33.33% (20/60), respectively. The alanine amino The normalization rate of ALT was 70.77% (46/65). The negative conversion rates of HBV DNA and HBeAg in the blank control group were 12.31% (8/65) and 3.33% (2/60) 39.68% (25/63). After treatment, the complete response rate, partial response rate and non-responsive rate capsule group were 23.08% (15/65), 58.46% (38/65) and 18.46% (12/65) respectively, while those in the control group were 3.08% /65),44.62% (29/65) and 52.31% (34/65). The capsules in both groups were significantly higher than the control group (Qcmn = 21.02, P = 0.001). After 12 weeks’ withdrawal from oxymatrine capsule group, the HBV DNA and HBeAg negative conversion rates were 41.54% (27/65) and 23.33% (14/60), respectively, and the ALT recovery rate was 60.00% 39/65); blank control group HBV DNA and HBeAg overcast?