CAJ | 학술논문

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.
목적 평개환원형곡광감태장용효낭치료만성을형간염적유효성화안전성.방법 채용다중심、수궤、쌍맹쌍모의、양성약평행대조적림상시험방법.입선인군위경、중도만성을형간염환자204례,수궤분성환원형곡광감태장용효낭치료조화환원형곡광감태편치료조,매조102례.복약방법위0.4 g/차,3차/d구복,료정12주.공유17례환자탈락,실제187례가공료효평개급안전성평개.비정태분포적계량자료채용질화검험,계수자료채용잡방검험.결과 치료12주말,환원형곡광감태장용효낭조(ALT:64 U/L비134 U/L,T=-1050.5,P＜0.01；AST:47 U/L비76 U/L,T=-1033.5,P＜0.01;TBil:15 μmol/L비16 μmol/L,T=-681.0,P＜0.05;γ-GT:38 U/L비47 U/L,T=-545.0,P＜0.05)화환원형곡광감태편조(ALT:72 U/L비122 U/L,T=-1205.5,P＜0.01;AST:51 U/L비72 U/L,T=-1187.5,P＜0.01;TBil:15 μmol/L비17 μmol/L,T=-624.5,P＜0.05；γ-GT:36 U/L비52 U/L,T=-776.0,P＜0.05)다항간공능지표균교치료전현저개선.환원형곡광감태장용효낭조현효솔급유효솔분별위28.72％(27/94)화12.77％(12/94),환원형곡광감태편조분별위18.28％(17/93)화12.90％(12/93),량조간차이무통계학의의(x2 =0.679,균P＞0.05).환원형곡광감태장용효낭조화환원형곡광감태편조[불량사건발생솔:10.64％(10/94)비10.75％(10/93);약물상관적불량사건발생솔:1.1％(1/94)비0；균P＞0.05]교소발생불량반응,안전성교호.결론 환원형곡광감태장용효낭능현저강저만성을형간염적전안매수평,차안전성량호.
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/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:15 μmol/L vs 17 μmol/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 (x2=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,respectively,P＞0.05],with good safety.Conclusion Reduced glutathione enteric-coated capsule significantly decreases aminotransferase levels in chronic hepatitis B with good safety.