甘草酸二铵脂质复合物肠溶胶囊与甘草酸二铵胶囊对照治疗慢性乙型肝炎60例  

Efficacy and safety of diammonium glycyrrhizinate phosphatidylcholine complex in adults with chronic hepatitis B

作　　者：陈勇[1] 李晶[1] 丁曙光[1] 丁琦[1] 张尔康[1] 胡丽佳 黄建军[1] 

机构地区：[1]江苏省淮安市第四人民医院,淮安223300

出　　处：《中国新药杂志》2006年第1期53-55,共3页Chinese Journal of New Drugs

摘　　要：目的:评价甘草酸二铵脂质复合物肠溶胶囊(甘平)治疗慢性乙型肝炎的临床疗效及安全性。方法:采用随机、盲法、平行对照的方法。60例伴有谷丙转氨酶(ALT)升高的慢性乙型肝炎患者分成试验组和甘草酸二铵胶囊对照组各30例。两组剂量均为:第1～10周450 mg·d-1,tid;第11周300 mg·d-1,tid;第12周150 mg·d-1,tid;疗程均为12周,停药后随访4周。观察两组的临床症状、血生化指标及不良反应。结果:试验组的总有效率显著高于对照组(73．3％vs 50．0％,P<0．01)。与对照组相比,试验组在给药4,8,12周时的ALT和谷草转氨酶(AST)降低更明显(P<0．01)。两组均无明显的不良反应。结论:甘草酸二铵脂质复合物肠溶胶囊对幔性乙型肝炎患者安全有效,降低ALT和AST的作用优于甘草酸二铵胶囊。Objective：To evaluate the efficacy and safety of diammonium glycyrrhizinate phosphatidylcholine complex （DGLL） enteric capsules for the treatment of chronic hepatitis B （CHB）. nethods：A randomized, double-blind and parallel comparison clinical study enrolled 60 patients with CHB plus escalated ALT level （ALT〉60IU· L^-1） were randomized 1：1 to receive either DGLL or diammonium glycyrrhizinate （DG） three time a day. Each group was force-tapered over 12 weeks treatment period, i.e. , 450 mg·d^-1 of DGLL or DG for the first 10 weeks as the initial dose was tapered down to 300 mg·d^-1 in 11th week and then 150 mg·d^-1 in 12th week. The patients were followed up for 4 weeks after complement of the drug treatment. The efficacy and safety profiles were evaluated based on the symptom and biochemistry, examination. Results： The overall efficacy rate of DGLL treatment was significantly greater than the DG treatment （73.3% vs. 50.0% ,P 〈0.01 ）. DGLL-treated patients experienced the significant improvements of AST and ALT levels from the 4th week of the treatment, compared with DG-treated patients （P〈0.01）. Such improvements became more significantly different at the 8th-and 12th-week of the treatment. All treatments were well tolerated. No adverse events were reported. Conclusion： DGLL offered better therapeutic option in patients with chronic hepatitis B.

关 键 词：甘草酸二铵脂质复合物 慢性乙型肝炎 甘草酸二铵 

分 类 号：R512.6[医药卫生—内科学] R975.4[医药卫生—临床医学]