| This paper is divided into three parts:the first part is literature review and meta-analysis,the second part is clinical research,and the third part is experimental research.1 Literature Review and Meta-analysis1.1 Literature ReviewRecent five years of literature review the current research progress of type 2 diabetes mellitus(T2DM)with nonalcoholic fatty liver disease(NAFLD).Chinese medicine treatment of NAFLD has certain advantages.The pathogenesis of NAFLD is the deficiency of spleen and kidney,stagnation of phlegm and toxin,Obstruction of Liver Collaterals,and the location of the disease is in the liver,spleen and kidney.In the treatment,it mainlyproposed two basic therapies of tonifying kidney and benefiting qi,and eliminating Turbid Fluid and removing Toxicity.Good results have been achieved in clinical practice.1.2 Meta-analysisObjective:Through the search of published clinical research literature,Meta analysis was used to evaluate the randomized controlled trial of NAFLD of Kidney-nourishing therapy at home and abroad,so as to provide evidence for the treatment of NAFLD.Methods:According to the requirements of the Cochrane system evaluation manual,electronic retrieval including China Academic Journal Full-text Database(CNKI),VIP Chinese scientific journal database(VIP),Wanfang database,The Cochrane Library,PubMed andEMbaseetc.these Chinese and English electronic databasewas used to collect a randomized controlled trial on the treatment of NAFLD with the method of tonifying kidney.Screen the literature according to the inclusion and exclusion criteria and use the Cochrane collaboration bias risk assessment tools in the study of methodological quality evaluation to draw the basic information of the study,and Use Rev Man5.3softwarerecommended by Cochrane evaluation system to analyze inclusion study with Meta-analysis.Results:A total of 13 subjects(1031 patients with NAFLD)were enrolled in the study,of which there were 543 patients in the treatment group and 488 patients in the control group.11 subjects included in the total effective rate have clear reports and the Meta-analysis results support that the treatment group with the kidney tonifying method is superior to the control group in the treatment of NAFLD and the difference has the statistical significance(P<0.05).Results showed that funnel diagram hadasymmetry,suggesting that the inclusion study had publicationbias.Meta analysis showed that the treatment group with the kidney tonifying methodis superior to the control group in improving liver function,insulin resistance index and reducing TC,TG,LDL-C and so on,and the difference has the statistical significance(P<0.05).Conclusion:Compared with traditional Chinese medicine and Western medicine,the kidney tonifying method can improve the total effective rate of nonalcoholic fatty liver disease,and has some advantages in improving liver function,blood lipid,insulin resistance and so on.2 Clinical researchObjective:To explore theclinical efficacy of modifiedShuiluErxian Danfordiabeticpatients with non-alcoholic fatty liver diseasecompared by the symptoms,adverse reactions,blood biochemical index,abdominal ultrasonography,providingthe clinical curative effectbasis for themethod of Gushen Yiqi Jieduin treatment of type 2 diabetes mellitus with NAFLD.Methods:72 casesof diabetic patients,diagnosed as non-alcoholic fatty liver diseasewith deficiency of spleen and kidneyand Zhuodu stagnation,were selectedfrom the outpatient and inpatientof Guang’ anmen hospital.According to the inclusion and exclusion criteria collected the patients,signed informed consent,collected general information and related the history of diseaseof the patients.According to the proportion of 1:1,the patients were randomly divided into basic treatment plus traditional Chinese medicine group and the basic treatment group.Basic treatment plus traditional Chinese medicine group was given conventional therapy,combined with Western medicine hypoglycemic treatment,while taking the modified Shuilu Erxian Dan(main drugs:Semen Euryales 20g,Fructus Rosae Laevigatae 20g,Rhizoma CoptidislOg,Radix Astragali30g),all Chinese medicine were the standard pieces,decocted byGuang’anmen hospital Decoction room.Dosage:one dose daily,twice a day.On the basis of conventional treatment,the treatment group was treated with conventional Western medicine.Before and after treatment,the clinical efficacy,biochemical parameters and abdominal ultrasonography were observed.Fasting blood was collected in the morning,and the biochemical indexes were detected by Guang’anmen hospital.Abdominal B ultrasonic examined by Guang’anmen hospital B ultrasonic room.To comparethe differencesof the indexes for non-alcoholic fatty liver disease in patients with type 2 diabetes mellitus before and after the treatment by statistical analysis after the collection of the data and explore the clinical curative effect for non-alcoholic fatty liver diseasecombined withdiabetes with the treatment of modified Shuilu Erxian Dan.Results:Clinical study found that thetotal efficiencyofthe modified Shuilu Erxian Dan group in diabeticpatients with fatty liver significantly better than the control group.The treatment group was better than the control group in the TCM syndrome scores.The results showed that the modified Shuilu Erxian Dan can effectively reduce the patients with diabetic fatty liver of fasting and 2 hour postprandial blood glucose,and the insulin levels also reduced.The modified Shuilu Erxian Dancan improve the grade of fatty liver in diabetic patients with NAFLD,the curative effect is better than that of control group.Conclusion:The modified Shuilu Erxian Dan can effectively alleviate insulin resistance of the patientsand improvepatients’ glucose metabolism,lipid metabolismandthe condition of hyperinsulinemia,while decreasing the body weight,thereby preventing the occurrence and development of diabetic fatty liver.3 Experimental studyObjective:To observe the effects of modifiedShuilu Erxian Danfor diabetic rats induced by high-fat diet combined with low-dose streptozotocin(STZ)in lipid,blood glucose,insulin levels andpathological changesin liver tissue,To investigate theinterventionmechanism ofmodifiedShuilu Erxian Dan forthe blood lipid and NAFLD,providing the experimental basis for the method of Gushen Yiqi Jieduwhich guide thetreatment of diabetic patients with NAFLD.Methods:the rats6-8 weeks oldwere randomly divided into normal group,model group,rosiglitazone group,and modifiedShuilu Erxian Dan group,each group included 8 rats.The control group was treated with basic diet,the other groups were fed with high fat and high calorie diet for 4 weeks.After 4 weeks of feeding,inhibited from drinking and food forl2h in the night,the model group was given intraperitoneal injection of 1%streptozotocin(STZ)solution by 35mg/Kg,to establish the model of type 2 diabetes mellitus;normal control group was injected with the same dose of Citric acid-sodium citrate buffer solution.Normal control group:Given normal salinegavageand basal diet;the model groupwith normal salinegavage,while giving high fat and high calorie diet;Chinese medicine treatment group:given modifiedShuiluErxianDan Decoctiongavage,containing crude drug 7g/kg/d,at the same time,fed them with high fat and high calorie diet;rosiglitazone group:given Rosiglitazone 0.3mg/kg/dgavage,while giving highfat and high calorie diet.After 4 weeks killed the rats,testing the changes of serum blood lipid,blood glucose and insulin levels;then removed the liver tissue for paraffin section hematoxylin and eosin(HE)staining to observe the histological changes;statistical method was used to analyze thecollecteddata,to observe the effect of modified Shuilu Erxian Dan on the above indicators.Results:In general,compared with normal control group,the body quality levels were significantly decreasedin model group,rosiglitazone group,modified Shuilu Erxian Dan group.Meanwhile,liver weight andliver weight index increased significantly.Compared with the model group,both ofthe normal control group and modified Shuilu Erxian Dan group showed significantly decreasedin the liver weight index.Lipid detection showed that,compared with normal control group,the serum TC levels of the rats were significantly elevated in model group,rosiglitazone group,modified Shuilu Erxian Dan group.Compared with normal control group,the levels of serum LDL-C and TG were significantly increased in model group and rosiglitazone group.Compared with the model group,both serum TC and LDL-C levels were significantly decreasedin normal control group,rosiglitazone group,modified Shuilu Erxian Dan group.Compared with the model group,the rats’ serum level of TG decreased significantlyin normal control group and modified Shuilu Erxian Dan group.Radioimmunoassay results showed that compared with normal control group thefasting blood glucose andthe index levels of insulin resistanceof the rats increasedsignificantly inmodified Shuilu Erxian Dan group,rosiglitazone groupand the model group.Compared with the normal control group,rosiglitazone group and model group showed significantly higher insulin levels.Compared with the model group,serum insulin levels ofrats decreased significantly in both the modified Shuilu Erxian Dan group and normal control group.HE staining showed that the morphology of normal liver cells and hepatic lobule structure were clear and complete,and the hepatic cords were arranged orderly,radiative with the central vein as the center.And the liver cell was clear.The liver of the rats in the model group showed fatty degeneration.And the hepatic lobules were destroyed,with the hepatic cords were disordered.At the meantime the liver cells were swollen,while the volume of the cells was increased,and there was a lot of fat accumulation in the cells.Compared with the model group,hepatic steatosis were alleviated to some extent inmodified Shuilu Erxian Dan group and rosiglitazone group,while intracellular lipid droplets decreased.Conclusion:The modified Shuilu Erxian Daninstructed by the method of Gushen Yiqi Jieducan alleviate the pathological and histologicalchanges in a certain extentin NAFLD,whichshould be related to its function that decrease the serum lipid level.The improvement of insulin resistance would be one of the mechanisms ofThe modified Shuilu Erxian Dan in the prevention and treatment for NAFLD. |
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