The Clinical Research On The Changes Of Blood Coagulation Function In Early And Clinical Stages Of Diabetic Nephropathy And Intervention With Furongtongmai Capsule

Objective: To explore the changes of blood coagulation function and influencing factors in early and clinical stages of diabetic nephropathy(DN)and to speculate on the risk of thrombosis;Further to observe the clinical effect and the effect of the hospital preparation-Furongtongmai capsule on blood coagulation function in DN patients with syndrome of qi and yin deficiency with blood stasis and to explore the mechanism of the effect on blood coagulation function to provide theoretical basis for clinical application.Methods:From January 2015 to December 2015 in the inpatient and outpatient department of our hospital diabetes,112 type 2 diabetes mellitus(T2DM)patients were selected by randomized and controlled methods according to the inclusion criteria,30 healthy persons selected randomly as normal control group(NC group)in our hospital medical examination center.According to urinary albumin and creatinine ratio(ACR),diabetes mellitus(DM)patients were divided into 3 groups: ACR(male)<2.5mg/mmol,ACR(female)<3.5mg/mmol as normal albuminuria group(NA,n=34),ACR between 2.5(male)/3.5(female)mg/mmol and 30.0mg/mmol as micro albuminuria group(MA,n=40),ACR>30.0mg/mmol as macro albuminuria group(LA,n=38).Blood samples were obtained after fasting 8-12 hours to examine triglyceride(TG),total cholesterol(TC),low-density lipoprotein cholesterol(LDL-C),fasting plasma glucose(FPG),glycosylated hemoglobin(HbA1c),2 hour plasma glucose(2hPG),liver function,renal function and to test R value,K value,CI value,MA value,Angle angle value of the thrombelastogram(TEG)to evaluate the changes of blood coagulation function in DN patients.34 cases patients with syndrome of qi and yin deficiency with blood stasis were chosen from MA group(n=40),randomly divided into treatment group and control group;32 cases patients with syndrome of qi and yin deficiency with blood stasis were chosen from LA group(n=38),randomly divided into treatment group and control group.Control group received blood glucose control,lipid-lowering,regular diet and behavior intervention.Except routine therapy,treatment group included Furongtongmai capsule treatment with 5 capsules each time,3 times a day orally.Observation time lasting for 8 weeks,the main observations were as follows: the clinical symptoms and signs,FPG,2hPG,HbA1 c,TG,TC,LDL-C,ACR,liver function,renal function,and R value,K value,CI value,MA value,Angle angle value of the TEG.At the same time,safety was evaluated.Results: 1 Compared with the NC group,the level of R value and K value were all decreased in NA,MA and LA group,and the difference had statistical significance(P<0.05);with the development of DN,the level of R value and K value were gradually decreased,and the difference between groups had statistical significance(P<0.05);Compared with the NC group,the level of Angle angle value,MA value and CI value were all increased,and the difference had statistical significance(P<0.05);with the development of DN,the level of Angle angle value,MA value and CI value were gradually increased,and the difference between groups had statistical significance(P<0.05).2 Linear correlation analysis showed that R value and K value were negatively related with ACR(r=-0.464,-0.546,P<0.01),and Angle angle value,MA value and CI value were positively related with ACR(r=0.654,0.765,0.737,P<0.01).3 Logistic regression analysis showed that duration of diabetes,smoking,blood lipids and proteinuria were the independent risk factors for the hypercoagulative state of DN(OR=1.314,2.083,2.514,4.613,P=0.000,0.037,0.032,0.025).4 After 8 weeks of treatment,blood glucose and lipids levels were significantly improved in MA and LA group(P<0.05),but comparing between groups after treatment,the difference of treatment and control group had no statistical significance(P>0.05);Meanwhile,the symptoms and signs(dry throat and tongue,fatigue,foam urine,tongue with ecchymosis)were significantly improved(P<0.05)and total chinese medicine symptom score descented obviously and the difference had statistical significance;Besides,the level of ACR,Angle angle value,MA value and CI value were decreased,and the level of R value and K value were increased(P<0.05).Furthermore,compared with pre-post treatment,the difference of liver function and renal function had no statistical significance and there were no adverse reactions during the tests.Conclusion:1 Compared with healthy adults,enhanced coagulation function in diabetics has occurred before proteinuria;While coagulation disorders gradually worsen in the early and clinical stages of DN,patients are in hypercoagulative state,increasing the risk of thrombosis.Therefore,we infer that the risk of thrombosis increases by degrees with the development of DN,there being linearity correlation between them.2 The hypercoagulative state in DN patients is associated with duration of diabetes,smoking,blood lipids and proteinuria.However,the risk coefficient of proteinuria is highest,and the risk of thrombosis will successively increase 4.6-fold from persons without diabetes progress to diabetics with macro albuminuria.3 Furongtongmai capsule has no effect on the blood glucose and lipids levels of DN patients with syndrome of qi and yin deficiency with blood stasis,improving symptoms and signs(dry throat and tongue,fatigue,foam urine,tongue with ecchymosis),reducing urinary protein.At the same time,Furongtongmai capsule can improve the hypercoagulative state so as to prevent thrombosis.Furongtongmai capsule has high safety.