还原型谷胱甘肽肠溶胶囊用于慢性乙型肝炎治疗的多中心临床试验  

A multi-center clinical trial of reduced glutathione enteric-coated capsule in the management of chronichepatitis B

作　　者：王迎昕[1] 陈锡美[1] 李军[2] 胡坚方[3] 金清龙[4] 贺永文[5] 张照华[6] 王青[7] 龚作炯[8] 安萍[9] 李秀慧[10] 杨长青[1] 

机构地区：[1]同济大学附属同济医院消化科,上海200065 [2]南京医科大学第一附属医院感染病科 [3]江西省人民医院消化科 [4]吉林大学第一医院肝胆胰内科 [5]华中科技大学同济医学院附属协和医院传染科 [6]济南市传染病医院肝病科 [7]青岛市立医院消化科 [8]武汉大学人民医院感染科 [9]沈阳市第六人民医院肝病科 [10]首都医科大学附属北京佑安医院中西医结合科

出　　处：《中华传染病杂志》2013年第5期274-279,共6页Chinese Journal of Infectious Diseases

摘　　要：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0．4g／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：64U／L比134U／L，T=-1050．5，P〈0．01；AST：47U／L比76U／L，T=-1033．5，P〈0．01；Tgil：15μmol／L比16μmol／L，T=-681．0，P〈0．05；γ-GT：38U／L比47U／L，T=-545．0，P〈0．05）和还原型谷胱甘肽片组（ALT：72U／L比122U／L，T=-1205．5，P〈0．01；AST：51U／L比72U／L，T=-1187．5，P〈0．01；TBil：15μmol／L比17umol/L，T=-624．5，P〈0．05；γ-GT：36U／L比52U／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（X^2=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〉0．051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 reducedglutathione 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/L, T=- 1050. 5, P〈0. 01; aspartate aminotransferase （AST） ： 47 U/L vs 76 U/L, T= - 1033. 5, P〈0. 01; total bilirubin （TBil） ： 15 μmol/L vs 16 μmol/L, T= 681.0, P〈0.05; gamma glutamyltransferase （γ-GT）： 38 U/L vs 47 U/L, T=-545.0, P〈0.05] and control group （ALT： 72 U/L vs 122 U/L, T=-1205.5, P〈 0.01; AST： 51 U/L vs 72 U/L, T=-1187.5, P〈0.01; TBil： 15μmol/L vs 17μmol/L, T 624.5, P〈0.05; γ-GT： 36 U/L vs 52 U/L, T=-776.0, P〈0.05）. The rates of significant improvement and improvement in reduced glutathione enteric coated capsule group were 28. 72%（27/94） and 12. 77% （12/94）, respectively, and those in control group were 18. 28% （17/93） and 12. 90% （12/93）, respectively. The differences between two groups were not statistically significant （X^2=0. 679, P〉0.05 ）. The incidences of medication related adverse events were low [10.64 % （10/94） and 10. 75% （10/93） for reduced glutathione enteric-coated capsule group and control group

关 键 词：谷胱甘肽 肝炎 乙型 慢性 多中心研究 转氨酶类 胶囊 

分 类 号：R512.62[医药卫生—内科学]