| Objective: To observe the clinical of TCM method of Huanglian Wendan Decoction on syndrome of phlegm heat and blood stasis in non-alcoholic steatohepatitis,evaluate its safety.Methods: 100 cases who met the inclusion criteria were used a random number table metho drandomly divided into treatment group and control group 50 cases each,the treatment group was treated with Huanglian Wendan Decoction plus combined with the basic treatment plan,when the control group was treated with Silibinin Capsules combined with basic intervention.Compared baseline characteristics between the former group,the period is 12 weeks.To record the Liver / spleen CT 、 fibroscan detection value 、 TCM syndrome integral、body mass index、blood lipid index(TC、TG、HDL-C、LDL-C)、liver function index(ALT、AST、GGT)and safety index(Routine blood test、Urine routine、stool routine examination 、electrocardiogram、renal function),to evaluate the therapeutic effect and safety of Huanglian Wendan Decoction on syndrome of phlegm heat and blood stasis in non-alcoholic steatohepatitis.Results: 1、Comprehensive efficacy comparison:The total effective rate was88% in the treatment group,it was 74% in the control group.When compared to the control group,better efects were achieved in the treatment group,the difference was obvious(P<0.05).2 、 TCM symptoms integral comparison: Compared to after and before treatment of two groups,the difference was obvious(P<0.01);compared between groups after treatment,the also difference was obvious(P<0.01).3、Liver/spleen CT value comparison: Compared to after and before treatment of two groups,the difference was obvious(P<0.01);compared between groups after treatment,the also difference was obvious(P<0.05).4、Fibroscan readings comparison: Compared to after and before treatment of the treatment group,the difference was obvious(P<0.01),the difference also obvious when compared to after and before treatment of the control group(P<0.05);compared between groups after treatment,the difference was obvious(P<0.01).5、Detection value of liver function(ALT,AST,GGT)comparison: Compared to after and before treatment of the treatment group,the difference was obvious(P<0.01),the difference also obvious when compared to after and before treatment of the control group(P<0.05);when compared of ALT、AST detection value after treatment between groups,the difference was obvious(P<0.05),the difference also obvious is the GGT detection value(P<0.01).6、Blood lipid values(TC,TG,HDL-C,LDL-C)comparison: Compared to after and before treatment of two groups,the difference was obvious(P<0.01);compared between groups after treatment,the also difference was obvious(P<0.01).7、Body mass index comparison: Compared to after and before treatment of the treatment group,the difference was obvious(P<0.01),the difference also obvious when compared to after and before treatment of the control group(P<0.05);compared between groups after treatment,the difference was obvious(P<0.01).8、Safety testing: The safety index of two group patients are not apparent anomaly detection,and no adverse events and adverse reactions.Conclusion:1 、 Huanglian Wendan Decoction can reduce TCM syndrome score,FS value,BMI indicators,and improve Liver / spleen CT、liver function,blood fat index of syndrome of phlegm heat and blood stasis in non-alcoholic steatohepatitis.2、There was no abnormality in safety index and no adverse drug reaction by syndrome of phlegm heat and blood stasis in non-alcoholic steatohepatitis treated with Huanglian Wendan Decoction.3、Syndrome of phlegm heat and blood stasis in non-alcoholic steatohepatitis treated with Huanglian Wendan Decoction safe and effective,worthy of further study. |