Clinical Efficacy Of Jianpishu Shugan Qinghua Decoction On Non-alcoholic Fatty Liver Disease With Stagnation Of Liver Qi And Spleen Deficiency

Objective: 1.To study Sun’s clinical experience in the treatment of NAFLD with liver stagnation and spleen deficiency based on the theory of "Yiqizhouliu".2.To evaluate the efficacy and safety of JPSGQHF in the treatment of NAFLD with stagnation of liver qi and spleen deficiency.Methods: 1.This study first used the retrospective study to analysis Sun’s Clinical experience in the treatment of NAFLD.We summarized the basic information,syndrome types,prescriptions and blood biochemical index of NAFLD patients in 2018 at first,and evaluated their efficacy.Then association analysis and complex network diagram were used to find the core drugs for NAFLD patients with stagnation of liver qi and spleen deficiency.2.A prospective,randomized and comparative clinical study had been designed to evaluate the curative effect and safety of JPSGQHF.We planned to include 88 patients with NAFLD conformed to the TCM syndrome,and they were assigned to two groups in a 1:1 ratio randomly,then the patients were was treated with Polyene Phosphatidyl Choline and JPSGQHF respectively for 12 weeks.The primary outcome was TCM syndrome scores and Fibro Touch,and liver function,blood glucose,blood lipid and uric acid were observed as Secondary efficacy indicators.Results: 1.Analysis of Recipe Law(1)In the retrospective study,a total of 153 NAFLD patients were included,among which the type of liver stagnation and spleen deficiency was the most common(47.71%).(2)After treatment,ALT(p<0.001),AST(p<0.001),GGT(p<0.001),TC(p=0.010)had statistically significant differences compared with before treatment,while uric acid had no statistically significant difference(p=0.066).And the TCM symptoms of patients with stagnation of liver qi and spleen deficiency were improved compared with those before treatment.(3)The complex network diagram of drugs showed that the core drugs of liver stagnation and spleen deficiency type were Bupleurum,Radix Paeoniae Paeoniae,Radix Radix Northrophylla,Atractylodes Rhizoma,Poria,Tangerine Peel,Licorice Radix,Radix Salviae Salviae.(4)The JPSGQHF is the experienced prescription of Dr.Sun in the treatment of NAFLD with stagnation of liver qi and spleen deficiency.2.Clinical Effect Evaluation of JPSGQHF(1)In the prospective study,88 patients were included in the 2 groups,of which 6patients did not complete the trial(4 in the control group and 2 in the treatment group),and the drop out rate was 6.82%.(2)There was a positive correlation between CAP and HOMA-IR(p<0.05),the correlation coefficient r=0.39.(3)In terms of TCM syndrome scores,92.86% of the treatment group and 67.50% of the control group are effective respectively,and the treatment group had better efficacy in improving in improving the independent TCM symptoms such asbilges frowsty,fatigue,abdominal distension,loss of appetite and sigh.(4)In Fibro Touch,the treatment group could improve patients’ CAP and LSM(p<0.05),and CAP(p<0.05)was improved in the control group and there was no statistically significant difference in LSM(p>0.05),but the improvement was not as good as the treatment group.(5)At 12 weeks,ALT,AST,GGT in both groups decreased from baseline up to a point(p<0.05),but the treatment group was preferable to the control group in improving GGT(p=0.017).6)In terms of blood glucose and insulin,the FPG(p=0.002),Hb A1c(p=0.005)in the treatment group were improved.In addition,the treatment group could improve patients’ insulin levels(p=0.007)and and HOMA-IR(p=0.004),but no reduction was seen in the control group(p>0.05).In the treatment group,TC(p=0.006),TG(p=0.011)and VLDL(p=0.030)were improved,but there was no significant difference in LDL,HDL and FFA compared with pretreatment(p > 0.05).In terms of uric acid,the treatment group could reduce uric acid to a certain extent(p=0.003).7)In terms of safety,there was no obvious abnormality in blood and urine routine,renal function and ECG in 2 groups.Conclusion:(1)Based on the theory of " Yiqizhouliu " and clinical experience accumulation,Sun concluded the JPSGQHF to treat NAFLD with stagnation of liver qi and spleen deficiency,and its early curative effect is benign.(2)JPSGQHF has certain advantages in improving the fat content,liver function of NAFLD patients,and it may make glycolipid metabolism and even uric acid metabolism take a turn for the better.And it has a better improvement effect on the overall TCM symptoms of NAFLD patients with stagnation of liver qi and spleen deficiency,especially in the improvement of asbilges frowsty,fatigue,abdominal distension,inappetence,good breath and sigh.In terms of security,JPSGQHF has good safety.