Clinical Assessment Of Yi Shen Li Xue Xie Zhuo Tang In Treating The CKD-Mineral And Bone Disorder

Objective:This study will observe the changes of two groups of subjects,one of which will treat by the Yi Shen Li Xue Xie Zhuo Tang and the western medicine,while the other one only use the western medicine.And then to assessment the clinical curative effect and security of the first group;Under the guidance of the principle of prevention and therapy of Traditional Chinese Medical,this study will discuss and analyze the feasibility of the plasma FGF-23 as an early predictor on CKD-MBD vascular calcification by observation the plasma FGF-23 and other related indexes.Through this study,we wish to offer the doctors an idea and method to treat CKD-MBD.Method:Following the inclusion criteria and the exclusion criteria,40 patients were randomly divided into trial group and control group,20 patients in each group.The trial group treated by the Yi Shen Li Xue Xie Zhuo Tang and cooperated with the western medicine at the same time.The control group only treated by the western medicine therapy(drug:Calcitriol,manufacturers for Shanghai Roche Pharmaceuticals co.,LTD.,specification is 0.25 ug/grain,imported drug registration number H20091084,repackaging SFDA approval number J2010005;Calcium carbonate,the manufacturer for Wyeth Pharmaceutical co.,LTD.,the specification is 1.5 g/piece,batch number for H10950029).Both of the two groups treated for 12 weeks.Observed the TCM symptoms and singes/renal function(BUN,Scr and eGFR)/serum Ca/serum P/serum PTH/serum ALP,which were before and after treatment of the two groups of patients,and the plasma FGF-23(before treatment),heart colour to exceed.Results:(1)Renal function:After 12-weeks treatment,the average level of serum creatinine and blood urea nitrogen of the trial group both had declined,and the eGFR level of the trial group had increased.Each observation index were statistical significance(P<0.05 or P<0.01).The level of serum creatinine and the eGFR level of the control group had kept steady after treatment(P<0.05).The level of blood urea nitrogen of control group had declined dramatically than before(P<0.05).There were no differences in serum creatinine level,blood urea nitrogen level and eGFR level between the two groups before treatment(P>0.05).After 12-weeks treatment,the serum creatinine level of trial group was lower than the control group’s(P<0.05),and the eGFR level was higher than the control group’s(P<0.05).After treatment there was no statistical significance in the blood urea nitrogen level between the two groups(P>0.05).(2)serum phosphorus,blood calcium and parathyroid hormone:After treatment,the trial group had a lower serum phosphorus and parathyroid hormone level and a higher blood calcium level compared with before treatment(P<0.01 or P<0.05);After treatment,the control group has a lower serum phosphorus and parathyroid hormone level,but there were no statistical significance(P>0.05).The blood calcium level of control group was increased,the very significant statistical significance(P<0.01);Before treatment,there were no differences in serum phosphorus,blood calcium and parathyroid hormone between the two groups.After treatment,the serum phosphorus level of trial group was lower than the control group’s(P0.05),and so do the parathyroid hormone level,but it had no statistical significance(P>0.05).Blood calcium levels between the two groups had no statistical significance(P>0.05).(3)Traditional Chinese medicine curative effect:Compared with before treatment,both of the two groups had a lower syndrome integral,with very significant statistical significance(P<0.01);After treatment,the experimental TCM syndrome integral mean value is less than the control group obviously,the two had a statistically significant difference(P<0.05);After treatment,the control group total effective rate was 63.6%(14/22),and the treatment group total effective rate was 91.7%(22/24).The difference between the two groups had statistical significance(P<0.05).(4)Comprehensive therapeutic effect:① Comprehensive therapeutic effect of CKD:After treatment,the control group total effective rate was 45.4%(10/22),and the treatment group total effective rate was 75%(18/24).The difference between the two groups had no statistical significance(P>0.05).②Comprehensive therapeutic effect of CKD-MBD:After treatment,the control group total effective rate was 59.1%(13/22),and the treatment group total effective rate was 91.7%(22/24).The difference between the two groups had statistical significance(P<0.05).(5)The result of FGF-23:①Correlation analysis of FGF-23 and phosphorus,calcium,parathyroid hormone and ALP:The r between FGF-23 and phosphorus was 0.471,which indicates that there was a moderate positive correlation between the two(P<0.01).The r between FGF-23 and PTH was 0.464,which indicates that there was a moderate positive correlation between the two(P<0.01).The correlation between FGF-23 and calcium and ALP was no statistical significance(P>0.05).The r between PTH and ALP was 0.435,which indicates that there was a moderate positive correlation between the two(P<0.05).The correlation between PTH and calcium was no statistical significance(P>0.05).②Plot the ROC curve with FGF-23 as the variable,and the area under the curve is 0.794(P<0.01).When the Youden index is at its maximum,the cutoff value is 846.19pg/ml.Conclusion:The Yi Shen Li Xue Xie Zhuo Tang has a reliable curative effect on CKD-MBD.It can improve renal function and improve calcium phosphorus metabolism disorder;And can improve TCM symptoms and syndrome curative effect.It is safe and no side effects.FGF-23 has the sensitivity and specificity in vascular calcification to patients with chronic kidney disease(CKD)-MBD,its clinical value and reliability deserves further research.