复方甘草酸苷片治疗自身免疫性肝炎-原发性胆汁肝硬化重叠综合征的临床研究  

Clinical trial of compound glycyrrhizin tablets in the treatment of autoimmune hepatitis-primary biliary cirrhosis overlap syndrome

作　　者：冯香艳[1] 冯增涛 马玉卓[3] 

机构地区：[1]西安培华学院医学院,西安710125 [2]西安市临潼人民医院内三科,西安710600 [3]西安交通大学附属红会医院重症医学科,西安710064

出　　处：《中国临床药理学杂志》2018年第3期240-243,共4页The Chinese Journal of Clinical Pharmacology

基　　金：国家自然科学基金资助项目(81100274)

摘　　要：目的观察复方甘草酸苷片治疗自身免疫性肝炎-原发性胆汁肝硬化重叠综合征(AIH-PBC)的临床疗效及安全性。方法将46例AIH-PBC患者随机分为对照组23例和试验组23例。对照组予以10 mg·kg^(-1)熊去氧胆酸胶囊,qd,口服+醋酸泼尼松片口服,起始量0.5 mg·kg^(-1)·d^(-1),并逐渐减量至5 mg·d^(-1)维持治疗+硫唑嘌呤片50 mg·d^(-1),口服;试验组在对照组治疗的基础上,予以复方甘草酸苷片每次75 mg,tid,餐后口服。2组患者均连续治疗12个月。比较2组患者的临床疗效和药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为91.30%(21例/23例)和60.87%(14例/23例),差异有统计学意义(P<0.05)。试验组发生的药物不良反应以腹泻、胃肠不适和头痛为主,对照组发生的药物不良反应以腹泻和胃肠不适为主。试验组和对照组的总药物不良反应率分别为17.39%和26.09%,差异无统计学意义(P>0.05)。结论复方甘草酸苷片治疗AIH-PBC的临床疗效确切,且不增加药物不良反应的发生率。Objective To observe the clinical efficacy and safety of compound glycyrrhizin tablets in the treatment of autoimmune hepatitis-primary biliary cirrhosis with overlap syndrome（ AIH-PBC）. Methods Forty-six patients with AIH-PBC were randomly divided into control group and treatment group with 23 cases per group. Control group received 10 mg·kg^（-1） ursodeoxycholic acid capsule,qd,orally ＋ prednisone acetate tablet,orally,starting dose 0. 5 mg·kg^（-1）·d^（-1）,and gradually reduce to 5 mg·d^（-1） to maintain treatment ＋ azathioprine tablets 50 mg·d^（-1）,orally. Treatment group was given compound glycyrrhizin tablets 75 mg each time,tid,orally,on the basis of control group.Two groups were treated for 12 months. The clinical efficacy and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates of treatment and control groups were respectively 91. 30%（ 21 cases/23 cases） and 60. 87%（ 14 cases/23 cases） with significant difference（ P 〈0. 05）. The adverse drug reactions of treatment group were diarrhea,gastrointestinal discomfort and headache,which in control group were diarrhea and gastrointestinaldiscomfort. The incidences of adverse drug reactions in treatment and control groups were 17. 39% and 26. 09%without significant difference（ P〉 0. 05）. Conclusion Compound glycyrrhizin tablets have a definitive clinical efficacy in the treatment of AIH-PBC,without increasing the incidence of adverse drug reactions.

关 键 词：复方甘草酸苷片 自身免疫性肝炎-原发性胆汁肝硬化重叠综合征 安全性 

分 类 号：R28[医药卫生—中药学]