A Real-world Study Of Sanqi Danshen Tablets In The Treatment Of Non-alcoholic Fatty Liver Disease

Objective(s): Based on real-world clinical data,retrospective analysis and prospective observation of the treatment of non-alcoholic fatty live disease(NAFLD)by Panax Notoginseng Danshen Tablets from a Class A hospital and medical institution in Kunming were conducted,and the clinical efficacy and safety of Panax Notoginseng Danshen tablets in the treatment of NAFLD were discussed.To provide a scientific basis for the clinical treatment of NAFLD.Methods:1.Retrospective study: A total of 733 patients with NAFLD in a Grade-A hospital from January 2017 to November 2022 were included in a retrospective cohort study design and screened by the hospital Management Information System(His system).Patients were divided into the treatment group and control group according to whether they took Panax notoginseng Danshen tablets.The orientation proximity matching method(PSM)was used to match 246 patients in both the treatment group and the control group.The effectiveness and safety of the two groups were compared.Effectiveness evaluation: The levels of aspartate aminotransferase(AST),alanine aminotransferase(ALT),total bilirubin(TBIL),alkaline phosphatase(ALP),and glutamyltransferase(GGT)in the two groups were compared to evaluate the liver function level of patients.Total cholesterol(TC),triglyceride(TG),high-density lipoprotein cholesterol(HDL-C),low-density lipoprotein cholesterol(LDL-C),and hypersensitive C-reactive protein(HS-CRP)were compared between the two groups to evaluate blood lipid levels and inflammatory response.Safety evaluation: After comparing blood routine parameters(red blood cells(RBC),hemoglobin(HGB),white blood cells(WBC),platelets(PLT),neutrophil percentage(NEUT%),and lymphocyte percentage(LYMPH%)of two groups,Liver function indexes(AST,ALT,TBIL,ALP,GGT)and renal function indexes(creatinine(Cr),urea nitrogen(UR),uric acid(UA))were used to evaluate drug safety.2.Prospective study: Using a prospective self-controlled study design,a total of89 outpatients and inpatients with NAFLD in the endocrinology Department of the First Affiliated Hospital of Kunming Medical University from August 2022 to November 2022 and 64 patients who completed 12-week treatment by March 2023 were collected.On the basis of the same original treatment regimen,the patients were added to take panax notoginseng Danshen tablets,3 tablets each time,3 times a day,after meals for 12 weeks.Data of patients before and 12 weeks after taking panax Notoginseng tablets were collected to compare the efficacy and safety before and after taking panax notoginseng tablets.Effectiveness evaluation: Waist circumference and body mass index(BMI)were compared before and after medication.Controlled attenuation parameter(CAP)and liver hardness(LSM)were detected by instantaneous elastic imaging(Fibroscan)to evaluate the degree of fatty liver and liver fibrosis.According to the normal range of liver function indexes(AST,ALT,TBIL,ALP,GGT),the liver function indexes before and after medication were divided into normal(within the normal range of reference values)and abnormal(above the upper limit of the normal range of reference values).The changes of indexes before and after medication were compared to evaluate the liver function.According to the normal range of blood lipid indexes(TG,TC,LDL-C,HDL-C),the blood lipid indexes before and after medication were divided into normal(within the normal range)and abnormal(higher than the upper limit of the normal reference range).The changes of indexes before and after medication were compared respectively to evaluate the improvement of blood lipid.The effectiveness of medication was evaluated based on the above results.Safety evaluation: Drug safety was evaluated by comparing blood routine(RBC,HGB,WBC,PLT,NEUT%,LYMPH%),liver function index(AST,ALT,TBIL,ALP,GGT)and renal function index(Cr,UR,UA).Results:1.Retrospective study:A total of 246 pairs were successfully matched through the nearest 1:1 matching of propensity."Gender","race","age","BMI","smoking history","drinking history","allergy history","hypertension history","diabetes history","coronary heart disease history","medication situation","treatment course","treatment course",and "treatment course" of the two groups were matched before treatment.Liver function(AST,ALT,TBIL,ALP,GGT),kidney function(Cr,UR,UA),blood lipids(TC,TG,HDL-C,LDL-C),blood routine(RBC,HGB,WBC,PLT,NEUT%,LYMPH%),inflammatory indicators(HS-CRP)and so on are balanced.It was comparable(P>0.05).(1)Effectiveness comparisonCompared with the control group,the levels of TBIl and HS-CRP in the treatment group were significantly decreased after treatment(P<0.05),but the other liver function indexes(AST,ALT,ALP,GGT)and lipid indexes(TC,TG,HDL-C,LDL-C)had no significant changes(P>0.05).(2)Security comparisonAfter treatment,there were no significant changes in blood routine(RBC,HGB,WBC,PLT,NEUT%,LYMPH%),liver function indexes(AST,ALT,TBIL,ALP,GGT),renal function indexes(Cr,UR,UA)between two groups(P>0.05).No adverse reactions to Panax Notoginseng Danshen tablets have been reported.2.Prospective research:(1)Effectiveness comparisonCompared with the control group,the levels of TBIl and HS-CRP in the treatment group were significantly decreased after treatment(P<0.05),but the other liver function indexes(AST,ALT,ALP,GGT)and lipid indexes(TC,TG,HDL-C,LDL-C)had no significant changes(P>0.05).(2)Security comparisonAfter 12 weeks of NAFLD treatment with Panqi Danshen Tablets,blood routine(RBC,HGB,WBC,PLT,NEUT%,LYMPH%),normal liver function indicators(AST,ALT,TBIL,ALP,GGT),renal function indicators(Cr,UR,UA)were all fluctuated within normal range.No serious adverse reactions have been found.Conclusion(s):1.Retrospective study results showed that Panax Notoginseng tablets had good safety in the treatment of NAFLD,and significantly improved NAFLD-related efficacy indicators TBIL and inflammatory indicators HS-CRP.2.After 12 weeks of treatment with panax Sanqi Danshen Tablets,on the basis of maintaining the same BMI before and after treatment,the waist circumference,CAP and LSM values of patients were reduced,and the levels of AST,ALT,TBIL and GGT of patients with liver function abnormalities were significantly reduced,thus improving the degree of fatty liver and liver fibrosis.Good security at the same time.In conclusion,panax Notoginseng tablets have good safety in the treatment of NAFLD,and can effectively improve the degree of fatty liver and liver fibrosis in patients with NAFLD,with definite clinical efficacy.