目的 评价还原型谷胱甘肽肠溶胶囊治疗慢性乙型肝炎的有效性和安全性.方法 采用多中心、随机、双盲双模拟、阳性药平行对照的临床试验方法.入选人群为轻、中度慢性乙型肝炎患者204例,随机分成还原型谷胱甘肽肠溶胶囊治疗组和还原型谷胱甘肽片治疗组,每组102例.服药方法为0.4 g/次,3次/d口服,疗程12周.共有17例患者脱落,实际187例可供疗效评价及安全性评价.非正态分布的计量资料采用秩和检验,计数资料采用卡方检验.结果 治疗12周末,还原型谷胱甘肽肠溶胶囊组(ALT:64 U/L比134 U/L,T=-1050.5,P<0.01;AST:47 U/L比76 U/L,T=-1033.5,P<0.01;TBil:15 μmol/L比16 μmol/L,T=-681.0,P<0.05;γ-GT:38 U/L比47 U/L,T=-545.0,P<0.05)和还原型谷胱甘肽片组(ALT:72 U/L比122 U/L,T=-1205.5,P<0.01;AST:51 U/L比72 U/L,T=-1187.5,P<0.01;TBil:15 μmol/L比17 μmol/L,T=-624.5,P<0.05;γ-GT:36 U/L比52 U/L,T=-776.0,P<0.05)多项肝功能指标均较治疗前显著改善.还原型谷胱甘肽肠溶胶囊组显效率及有效率分别为28.72%(27/94)和12.77%(12/94),还原型谷胱甘肽片组分别为18.28%(17/93)和12.90%(12/93),两组间差异无统计学意义(x2 =0.679,均P>0.05).还原型谷胱甘肽肠溶胶囊组和还原型谷胱甘肽片组[不良事件发生率:10.64%(10/94)比10.75%(10/93);药物相关的不良事件发生率:1.1%(1/94)比0;均P>0.05]较少发生不良反应,安全性较好.结论 还原型谷胱甘肽肠溶胶囊能显著降低慢性乙型肝炎的转氨酶水平,且安全性良好.
Objective To evaluate the efficacy and safety of reduced glutathione enteric-coated capsule in the management of chronic hepatitis B.Methods A multi-center,randomized,double-blind and double-dummy,positive-and parallel-controlled trial was conducted in patients with mild or moderate chronic hepatitis B.Two hundred and four subjects were randomly divided into reduced glutathione enteric-coated capsule group (n =102) and control group (reduced glutathione tablet group,n=102).Patients in both groups were orally dosed 0.4 g three times daily for 12 weeks.There were 17 dropout cases,and finally 187 patients were available for the assessment.Difference of quantitative date was analyzed by rank sum test,and differene of measurement date was compared with analysis of variance.Results At the end of week 12,parameters of liver functions were significantly improved when compared with baseline in both reduced glutathione enteric-coated capsule group [alanine aminotransferase (ALT):64 U/L vs 134 U/