丹夏脂肝方治疗非酒精性脂肪性肝病的病证结合临床研究

Clinical Research of Danxia Zhifang Decoction in Treating Non-alcoholic Fatty Liver Disease

目的:评价丹夏脂肝方治疗湿浊瘀结型非酒精性脂肪性肝病的病、证疗效特点及其相关性,探索病证结合疗效评价思路与方法。方法:采用随机、阳性药物平行对照、双盲观察临床试验设计,将纳入受试者按完全随机方式分为2组,分别接受丹夏脂肝方与强肝胶囊进行治疗,疗程3个月。主要观察指标为病证主要症状、肝脾CT比值及超声检查、肝功能、血脂。结果:丹夏脂肝方治疗湿浊瘀结型非酒精性脂肪性肝病总显效率、总有效率分别为40.82%、62.50%,中医证候的显效率与有效率为51.02%、91.84%,均优于对照药强肝胶囊(P<0.05);治疗后患者中医证候及主症积分、肝功能、血脂均有不同程度改善(P<0.05);治疗组病、证疗效以及中医证候积分的下降与非酒精性脂肪性肝病主要疗效评价指标的变化具有较好的相关性(P<0.05)。结论:1)丹夏脂肝方对湿浊瘀结型非酒精性脂肪性肝病有较好的改善症状、肝脾CT比值,肝功能及血脂作用。2)丹夏脂肝方治疗非酒精性脂肪性肝病的病证疗效以及中医证候积分与肝脾CT比值及肝功能改善具有良好相关性。

Objective：To study the curative effect of Danxia Zhifang decoction in treating non-alcoholic fatty liver disease of damp-ness-turbid stagnation syndrome and explore the TCMevaluation idea and treatment.Methods：Using parallell control and random double blind research by dividing the patients of non-alcoholic fatty liver disease into two groups：one takes Danxia Zhifang decoc-tion and the other Qianggan capsule for 3 months.Then observe the main symptoms,CT ratio of liver spleen,ultrasonic examina-tion,liver function and blood fat indexes of the two groups.Results：The total effeciency rate,total effective rate are 40.82% and 62.50% respectively and the total efficiency,total relief rate of TCMsyndrome are 51.02% and 91.84% respectively in the treat-ment group,which are of significant difference compared to those of the control group （P 〈0.05）.Indexes of syndrome integral, main symptoms integral,liver function and blood fat all have significant improvement after treatment （P 〈0.05）.Obvious correla-tions among indexes of curative effect of disease,relief effect of syndrome,induce of syndrome integral and main efficacy evaluation were observed in the teratment group （P 〈0.05）.Conclusion：Danxia Zhifang decoction has absolute curative effect in treating non-alcoholic fatty liver disease,and it can improve main symptoms,CT ratio of liver spleen,liver function and blood fat.In addi-tion,there are correlations among Danxia Zhifang decoctions curative effect,TCM syndrome integral,CT ratio of liver spleen and liver function.