| BackgroundNon-alcoholic fatty liver disease(NAFLD)is a high-risk factor for liver cirrhosis and liver cancer.It has become a serious public health problem worldwide,with a prevalence rate of about 30% of the population.At present,there is still no specific medicine for the treatment of NAFLD,and the prevention and treatment of NAFLD is a hot and difficult problem that needs to be solved urgently.The holistic view of traditional Chinese medicine and the differentiation of symptoms and signs have obvious characteristics and advantages in the treatment of such diseases with complex etiology and pathogenesis.However,the current status of traditional Chinese medicine treatment of NAFLD has not been systematically reviewed.On the basis of many years of clinical practice and scientific research,the tutor,Professor Guo Jiao,has proposed the prevention and treatment strategy of "Tiaohe Liver Qishu Huazhuo Method" for the glucose and lipid metabolism diseases including NAFLD,and formulated the Zhenzhu Tiaozhi Fang(FTZ),the prescription mainly includes bergamot,Ligustrum lucidum,Atractylodes macrocephala,Panax notoginseng,Danshen and other medicinal flavors.It has the functions of invigorating the kidney,regulating the liver,invigorating the spleen and resolving turbidity.It is clinically used as an in-hospital preparation for NAFLD,hyperlipidemia,diabetes and other sugars.Lipid metabolism disorders for many years.However,due to the intricacies of the disease in the real world,the severity of the disease,complications,and combination medications will affect the efficacy of FTZ.Therefore,it is urgent to clarify the characteristics of the effect of FTZ in the treatment of NAFLD in the real world.ObjectiveIn order to study the characteristics of the effects of FTZ in the treatment of NAFLD in the real world,based on the hospital electronic information system and outpatient health records,this subject research was carried out from various aspects such as liver Fibro Touch detection,serology,TCM efficacy,and quality of life.Precise application provides objective basis.Methods1.Research on the clinical literature on the treatment of NAFLD with traditional Chinese medicine: search the relevant clinical literature on the treatment of NAFLD with traditional Chinese medicine collected by CNKI and WANFANG DATA since the establishment of the database until December 31,2019.Duplicate checking,inclusion and exclusion criteria are used to screen the documents that meet the requirements,and the frequency analysis method is used to study the syndrome types and medication rules of the finally included documents to reveal the characteristics of traditional Chinese medicine in the treatment of NAFLD.2.Before-after study in the same patient: According to the inclusion and exclusion criteria,NAFLD patients were selected in the outpatient and inpatient departments of the First Affiliated Hospital of Guangdong Pharmaceutical University.Collect the patient’s basic information,comorbidities,and drug combination characteristics,and measure the liver fat controlled attenuation parameters(CAP)and liver stiffness values at the 4 time nodes of treatment 0month,1 month,3 months,and 6 months,respectively(LSM),body mass index(BMI),alanine aminotransferase(ALT),aspartate aminotransferase(AST),gamma-glutamine transpeptidase(GGT),total cholesterol(TC),triglycerides(TG),low density Lipoprotein(LDL-C),high density lipoprotein(HDL-C),fasting blood glucose(FPG),postprandial 2h blood glucose(2h PG),glycosylated hemoglobin(Hb A1c),fasting insulin(FINS),insulin resistance index(HOMA-IR),urea nitrogen(BUN),and creatinine(Cr)were evaluated before and after their own comparative curative effects.At the same time,the carotid intima-media thickness(IMT),TCM symptom score and SF-36 quality of life score of NAFLD patients before and after treatment were analyzed.3.Retrospective case-control study: Taking electronic medical records and clinical data as data sources,taking NAFLD patients as the research object,using retrospective case-control studies as the design method,and dividing it into FTZ treatment according to whether or not to accept Zhenzhu Tiaozhi Capsule(FTZ)Group(47 cases)and non-FTZ treatment group(192 cases).Using the propensity score matching method(PSM)as a tool to control confounding factors,the differences in CAP,LSM and BMI between the FTZ group and the non-FTZ group before and after treatment were compared.Results1.The literature research results show that: modern physicians believe that the disease location of NAFLD is in the liver,spleen and stomach,and kidneys,and advocate the co-regulation of liver,spleen and kidneys.The common syndromes of NAFLD are liver depression and spleen deficiency,mutual accumulation of phlegm and blood stasis,accumulation of dampness and heat,internal resistance of phlegm and dampness,spleen deficiency and phlegm dampness.The prescriptions used in clinical practice are mostly tonic drugs(Atractylodes macrocephala,licorice),diuretic and dampening drugs(Poria,Alisma),blood promoting and stasis removing drugs(Salvia,Turmeric),heatclearing drugs(Cassia seed),Qi regulating drugs(Tangerine peel),etc.2.The results of before-after study in the same patient show that:(1)Hepatic steatosis: The effective rate of liver fat content in NAFLD patients was 50% after 1 month and 3 months of treatment,and CAP and LSM were lower than before treatment(P<0.05,P<0.01).(2)Anthropological indicators: BMI of NAFLD patients decreased after 3months of treatment compared with before treatment(P<0.05).(3)Laboratory indicators: After FTZ intervention,the total effective rate of treatment of NAFLD patients gradually increased with the extension of the treatment course,and the effective rate was the highest(68.09%)after 3 months of treatment.Maintained at a stable level after 12 months.After treatment,ALT,AST,TC,TG,LDL-C,and BUN were significantly lower than before treatment(P<0.05,P<0.01).After treatment,GGT,FPG,2h PG,Hb A1 c,HOMA-IR showed a downward trend,and the difference was not statistically significant(P>0.05).(4)IMT: After FTZ intervention,the bilateral IMT of NAFLD patients showed a downward trend compared with before treatment,and the left side was better than the right side.There was no significant difference compared with before treatment(P>0.05).(5)Effect of traditional Chinese medicine: After FTZ intervention,the total score of TCM symptoms in NAFLD patients was lower than before treatment(P<0.05,P<0.01);individual TCM symptoms(fatigue,fatigue,weakness,knee weakness,forgetfulness,numbness,frequent nocturia)Many,dry eyes)and other effective rate ≥ 60%.(6)Quality of life: NAFLD patients’ physical function,general health status,mental health,physical health total score,and mental health total score decreased after FTZ intervention(P<0.05,P<0.01).3.The results of a retrospective case-control study showed that 47 cases of FTZ group with CAP,LSM and BMI indicators before and after treatment were matched with 192 cases of non-FTZ group.A total of 30 pairs of samples were successfully matched,with BMI level before matching(P=0.045),Chinese herbal medicine(P=0.004),liver-protecting and enzyme-lowering drugs(P=0.009),lipid-lowering drugs(P=0.004),and hypoglycemic drugs(P=0.008)were unevenly distributed among the groups,and the variables were evenly distributed after matching.The matched results showed that the CAP,LSM,and BMI after treatment in the FTZ group were lower than before treatment(P<0.01);after treatment in the non-FTZ group,CAP was lower than before treatment(P<0.01).After treatment,LSM,BMI were similar to those before treatment.The difference was not statistically significant(P>0.05);the difference in LSM before and after treatment in the FTZ group was compared with the non-FTZ group,and the difference was statistically significant(P<0.05);the difference in CAP before and after treatment in the FTZ group was compared with the non-FTZ group,The difference was not statistically significant(P>0.05)Conclusions1.By systematically combing the clinical research literature on the treatment of NAFLD with traditional Chinese medicine,it reveals the characteristics of the traditional Chinese medicine for the treatment of NAFLD,emphasizing the homology of liver,spleen and kidney,and liver depression and spleen deficiency is one of its main syndromes."The liver Qishu Huazhuo" method fits well.2.The treatment of NAFLD with FTZ has a significant clinical effect,and its effect characteristics are: it can effectively improve the CAP,LSM,BMI,ALT,AST,TC,TG,LDL-C,BUN of NAFLD patients.Most of them are treated effectively for 1-3 months,and FTZ can effectively improve the TCM symptoms of liver and kidney deficiency such as fatigue,fatigue,weak knees,forgetfulness,numbness,frequent urination at night,dry eyes and other symptoms of liver and kidney deficiency,and improve the quality of life of patients.3.FTZ treatment of NAFLD has obvious advantages in improving LSM value.In summary,based on the analysis of real world clinical data,FTZ treatment of NAFLD can improve liver steatosis,resist liver fibrosis,reduce weight,reduce blood lipids,improve liver and kidney function,improve TCM symptoms,and improve quality of life.It is clinically worthwhile Further popularization and use can provide new ideas and methods for the treatment of NAFLD in Chinese medicine. |