摘要
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。
Objective ：To evaluate the safety and efficacy of Kehuanglidan capsule in treating Icteric Hepatitis B with Dampheat Syndrome of Liver-Gallbladder. Methods ： A Multi-dose, parallel-controlled, randomized, double-blind, doub-dummy, multicenter 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, I pill of dummy Kehuanglidan capsule, 1 bag of dummy Kubuang particles, three times a day. The treatment group 2 was treated with 3 pills of Kehuanglidan capsule, 1 bag of dummy Kuhuang particles,three times a day. And the control group was treated with 3 pills of dummy Kehuanglidan capsule, 1 bag of Kubuang particles, three times a day. The treatment durations in three groups were 7 days. Resu/ts ： After treatment, The average of total bilirubin decreased in treatment three groups. The differences were statistically sign/fie.ant（P 〈 0. 001 ） before and after treatment. The total effective of eliminating jaundice in three groups were 64. 06%, 58. 82% and 61.76% respectively, with no statistical significance （ P 〉 0. 05 ）. The total score of TCM syndrome of the three groups decreased week by week. The total effective of TCM syndrome were 98.44% ,97.06% and 97.06% respectively ,with no statistical significance（ P 〉 0. 05 ）. There was also no statistical significance in liver function test and the incidence of adverse reaction between groups （ P 〉 0. 05 ）. Conclusion： Kehuanglidan capsule is effective and safe in treating Ictefie Hepatitis B with Damp-heat Syndrome of Liver-Gallbladder.
出处
《辽宁中医杂志》
CAS
北大核心
2009年第6期948-951,共4页
Liaoning Journal of Traditional Chinese Medicine
关键词
克黄利胆胶囊
乙型黄疸型肝炎
肝胆湿热证
临床试验
Kehuanglidan capsule
icterie hepatitis B
damp-heat syndrome of liver-gallbladder
clinical trial
