克黄利胆胶囊治疗乙型黄疸型肝炎肝胆湿热证的临床研究

目的:评价克黄利胆胶囊治疗乙型黄疸型肝炎肝胆湿热证的有效性和安全性。方法:采用多剂量、平行对照、随机、双盲双模拟、多中心研究设计。216例患者被分为3组,试验1组给予克黄利胆胶囊2粒,克黄利胆模拟胶囊1粒,苦黄颗粒模拟颗粒1袋,每日3次;试验2组给予克黄利胆胶囊3粒,苦黄颗粒模拟颗粒1袋,每日3次;对照组给予克黄利胆模拟胶囊3粒,苦黄颗粒1袋,每日3次。疗程均为7天。结果:治疗后试验1组、试验2组与对照组的总胆红素均值均较治疗前降低,3组治疗前、后的总胆红素均值差异均有统计学意义(P<0.001);3组的退黄疗效总有效率分别为:64.06%、58.82%和61.76%,组间差异无统计学意义(P>0.05);3组的中医证候总积分较治疗前相比呈逐周下降趋势,中医证候总有效率分别为:98.44%、97.06%和97.06%,组间差异无统计学意义(P>0.05):3组的肝功检查分析及药物不良反应发生率比较均无统计学意义(P>0.05)。结论:克黄利胆胶囊治疗乙型黄疸型肝炎肝胆湿热证是安全有效的,值得临床推广使用。

A Randomized Trial of Kehuanglidan Capsule in the Treatment of Icteric Hepatitis B with Damp-heat Syndrome of Liver-Gallbladder

Objective:To evaluate the safety and efficacy of Kehuanglidan capsule in treating Icteric Hepatitis B with Damp-heat Syndrome of Liver-Gallbladder.Methods:A Multi-dose,parallel-controlled,randomized,double-blind,doub-dummy,multi-center study design was conducted.216 cases of patients were divided into three groups.The treatment group 1 was treated with 2 pills of Kehuanglidan capsule,1 pill of dummy Kehuanglidan capsule,1 bag of dummy Kuhuang particles,three times a day.The treatment group 2 was treated wit...