水飞蓟宾磷脂复合物防治脂肪肝的动物试验与临床观察

目的评价水飞蓟宾磷脂复合物防治脂肪肝的效果。方法①动物试验：将140只大鼠随机分为正常对照组、模型组、水飞蓟宾磷脂复合物干预组。应用皮下注射四氯化碳与饲喂含酒精的高脂饮食3周建立混合性大鼠脂肪肝模型。干预组同时每日分别给予不同剂量水飞蓟宾磷脂复合物灌胃。至3周末从模型组分出部分大鼠作为水飞蓟宾磷脂复合物治疗组，该组停止应用致脂肪肝药物，开始每日给予水飞蓟宾磷脂复合物灌胃持续3周；另外以部分模型组大鼠作对照，该组亦停止应用致脂肪肝饮食，与正常对照组均每日给予生理盐水灌胃，持续3周。分别于3周末和6周末分批处死大鼠，取肝组织做病理学检查；②临床试验：选取54例肝功能异常的脂肪肝患者，随机分成试验组（29例）和对照组（25例），试验组口服水飞蓟宾磷脂复合物治疗12周，对照组口服护肝宁片治疗12周。评价两组患者治疗前后临床症状、肝功能、血脂和肝脏B超的恢复情况，同时记录不良反应。结果①动物试验：肝组织病理检查显示，各干预组的肝脂肪变性、炎症坏死及纤维化程度与模型组比较减轻不明显。模型对照组肝组织大泡性脂变较模型组减轻，但小泡性脂变较模型组更加严重，并可见明显的纤维化。治疗组大泡性脂变程度仍然较明显，但小泡性脂变与纤维化程度明显轻于模型对照组；②临床试验：治疗后试验组和对照组病人的症状有不同程度改善，其中试验组有乏力、腹胀和肝区不适病人的症状改善率显著高于对照组。两组患者治疗后的肝功能指标与治疗前比较均得到显著好转，但两组间比较无显著性差异。治疗后两组的血甘油三酯没有明显变化，但试验组的血总胆固醇明显降低，而试验组没有明显变化。B超结果显示，试验组的脂肪肝好转率48．28％，而对照组仅8

Experimental and clinical study of silibin-phosphatidylcholine compound on fatty liver disease

Objective To investigate the effect of silybin-phosphatidylcholine compound（SPC）on the development of fatty liver in rats and evaluate the efficacy on patients with fatty liver disease （FLD）. Methods 1）animal experiment： 140 Wistar rats were divided into different groups randomly,which included normal control group,model group,high dose of silybin intervened group,middling dose intervened group,low dose intervened group,model control group,silybin therapeutic group （n=20 for each group）. Except normal control group,the animals of other groups were hypodermicly injected with carbon tetrachloride and plant oil mixture（two consecutive days/a week）and raised with the high fat material and alcohol for 3 weeks to establish the rat fatty liver model. From the first day of the hypodermic injection,rats in intervened groups were given silybin-phosphatidylcholine compound for 3 weeks by gastric breed,model and normal control group given saline at the same time. Liver tissues and blood samples of all rats in intervened groups and model group were examined on 21 days（3 weeks）. Rats in therapeutic groups were stopped injury factors but bred with silybin- phosphatidylcholine compound for another 3 weeks;in the same time,the model control group and normal control group were given saline by the same way. The pathological examination of hepatic tissues was analyzed. 2） clinical trial：54 patients with FLD （abnormal ALT level）were randomly devided into two different groups：The patients of trial group （n =29）were treated with SPC （ 120mg, tid）for 12 weeks, and the controlled group （n=25）were treated with Chinese herbs compound Huganning pills （4#,tid）. Before and after treatment for 4,8 and 12 weeks,the change of manifestations were estimated,the serum parameters of liver function,lipid,and ultrasonic image were detected for the patients of both groups. Results 1） animal experiment： Pathological examination suggested that in the intervened groups,liver fatty degeneration were sli