汉丹肝乐防治急性肝炎的临床试验及实验室研究

目的 :采用随机临床对照试验以及动物实验研究 ,以评估汉丹肝乐对急性肝炎的疗效。方法 :(1)急性病毒性肝炎病人共 10 0例 ,治疗组及对照组各 5 0例 ,两组病人的性别、年龄、病程等基础临床特征相似 ,具有可比性 (P >0 .0 5 )。治疗组汉丹肝乐 1.2 g口服 ,每日三次 ,疗程 1个月。 (2 )用CCl4 腹腔注射建立大鼠急性肝损伤模型。观察红细胞超氧化物歧化酶 (SOD)、肿瘤坏死因子 -a(TNF -a)、过氧化脂质 (LPO)、肝损伤血生物化学及鼠肝组织HE染色 ,测定肝损伤面积。结果 :汉丹肝乐能明显改善急性肝炎病人的症状体征及肝功能 ;减轻大鼠肝损伤面积 ,降低血清TNF -a、LPO ,升高红细胞SOD ,汉丹肝乐对肝损害的保护作用与齐墩果酸一致 ,两者之间无显著差异 (P >0 .0 5 )。结论 :汉丹肝乐具有保护肝细胞、降酶、退黄 ,防治急性肝损伤的作用

Experimental and Clinical Studies on the Treatment of Acute Hepatitis by Han-Dan-Gan-Le

Objective:This experiment was designed to explore the effects of treating acute hepatitis with HanDanGanLe ( HDGL ). Methods: (1)Patients received either HDGL (A) or oleanolic acid. (B) 1.2?g orally 3/d for 1 month , 50 were randomly assigned to group A and 50 to group B . Their baseline clinical characteristics were similar (P>0.05) and the curative effect after the treatment was observed. (2) Acute liver injury model was established by using CCl 4. Results: HDGL obviously reduced the symptoms and physical signs, and decreased serum levels of ALT , tumor necrosis factor-a (TNF-a) and malondialdehyde (LPO) as well as the area of hepatic injury. It also increased superoxide dismutase (SOD) in red blood cells . The protective effects of HDGL is the same as that of oleanolic acid(P>0.05) . Conclusions: HDGL is effective in protecting hepatocytes , lessening the symptoms and physical signs and protecting the liver from acute injury.