| ObjectiveTo observe the effect of different doses of DaHuangFuZiXiXin Decoction on the serum creatinine (Cr), blood urea nitrogen (BUN), glomerular filtration rate (GFR) and Podocalyxin (PCX) in chronic renal failure patients, as well as the preliminary tendency of clinical effect as the whole decoction dosage varying in certain range. To discuss the value of PCX in the treatment and prognosis in CRF by testing the changes of PCX in the patient's urine.Methods1. Selecting thirty CRF patients in early and medium stage(GFR: 30-59ml/min/1.73m2) with the syndrome of spleen and kidney yang deficiency and retention of phlegm and toxin. Randomly dividing them into three groups:low dosage group, middle dosage group and high dosage group, 10 cases in each group. Three groups all received four to six weeks basic therapy (diet management and symptomatic treatment with routine western medicine), then receiving high, middle, low doses of DaHuangFuZiXiXin Decoction separately. The treatment course is 3 months, to observe the clinical effect of DaHuangFuZiXiXin Decoction in different dosage, such as the changes of symptom integral, serum creatinine, blood urea nitrogen and glomerular filtration rate ect.2. On the basis of above treatment mentioned, selecting the middleperiod of the first morning urine from the 30 included patients of chronic kidney disease about 10ml pre and post treatment, stored in the refrigerator after centrifugation for detection, detecting urinary podocyte surface marker protein PCX by the method of enzyme-linked immunosorbent assay (ELISA). Comparing the changes of urinary podocyte surface marker protein (PCX) in different dose groups of DaHuangFuZiXiXin Decoction pre and post treatment.Results(一)The clincal effect of different doses of DaHuangFuZiXiXin Decoction in treating chronic renal failure.1. The primary therapeutic index(1) The effect of different doses of Dahuangfuzixixin Decoction in renal function index in patients of chronic renal failure:①Serum creatinine:Compared with pre treatment, the levels of serum creatinine in high dose group decreased significantly and the difference is statistically significant (P<0.05), the levels of serum creatinine in the middle dose group decreased, but compared with pre treatment, there is no statistical difference (P>0.05), the levels of serum creatinine in the low dose group increased, but compared with pre treatment, there is no statistical difference too (P>0.05). Comparing the levels of serum creatinine among the three groups after treatment, there is no statistical difference (P>0.05).②Blood urea nitrogen:the levels of blood urea nitrogen of three groups all decreased comparing with pre treatment, but there is no statistical difference among the three groups (P>0.05). Compared among groups after treatment, there is no statistical difference of the levels of blood urea nitrogen (P>0.05).③Glomerular filtration rate:Compared with before treatment, the hige dose group of DaHuangFu ZiXiXin Decoction increased significantly and the difference is statistically significant (P<0.05), the middle group increased, but there is no statistical difference (P>0.05), the low dose group decreased as compared with pre treatment, but there is no statistical difference (P>0.05). Compared the levels of Glomerular filtration rate among groups after treatment, there is no statistical difference of (P>0.05).It is proven that DaHuangFuZiXiXin Decoction of high dose group has a certain function to decrease Serum Creatinine and increase Glomerular Filtration Rate in chronic renal failure patients.(2) The effects of different doses of Da huangfuzixinxi Decoction on TCM syndrome grade in patients with chronic renal farilure:Compared with before treatment, the TCM syndrome grade of three groups decreased significantly and the difference is statistically significant(P<0.05); Compared among groups after treatment, the TCM syndrome grade of the high group decreased more significantly than the middle group and the low group and have statistical difference (P<0.05). The results indicate that Da Huang Fu Zi Xi Xin Decoction may play a certain role in improving TCM syndrome; the improvement of TCM syndrome of patients in the high group was obviously superior to those in the middle and low group.2. The secondary outcome measures(1)Comprehensive therapeutic effect:Compared among groups after treatment the comprehensive therapeutic effect of the three groups have no statistical difference (P>0.05).(2)Related experimental index:①HDL:Compared with before treatment, the levels of HDL of hige dose group increased significantly and the difference is statistically significant(P<0.05); Compared among groups after treatment, the levels of HDL of three groups have no statistical difference (P>0.05).②TCHO,TG,LDL,24Upro:there is no statistical difference before and after treatment and Compared between groups after treatment (P>0.05).These results suggested that Da Huang Fu Zi Xi Xin Decoction has a certain function to increase HDL, but has no obvious effect on other experimental indexs.(3) The quality of life score:The score of the hige group is 16.50±2.01 before treatment and 38.40±2.55 after treatment; The score of the middle group is 17.40±2.50 before treatment and 32.20±2.74 after treatment; The score of the low group is 19.10±2.64 before treatment and 34.90+4.89 after treatment. Compared with before treatment, The qu-ality of life scores of three group have statistical difference (P<0.05) Compared among groups after treatment, there is significant difference between high group and middle group(P<0.05), but no significant difference between middle group and low group (P>0.05).It shows that Da Huang Fu Zi Xi Xin Decoction can improve the quality of life of chronic renal failure patients, especially the high group. (H) The effects of different doses of Da huangfuzixinxi Decoction onurinary podocyte surface marker protein (PCX)in patients with chronic renal farilure1. The effects of different doses of Da huangfuzixinxi Decoction on urinary podocyte surface marker protein (PCX)in patients with chronic renal farilure.①Compared with before treatment, the levels of urinary podocyte surface marker protein (PCX) decreased significantly and the difference is statistically significant(P<0.05), but there is no difference in low group. Compared among groups after treatment, the levels of PCX of three groups have no statistical difference (P>0.05). It shows that Da Huang Fu Zi Xi Xin Decoction of high group and middle group has a certain function to reduce Podocyte Injury.2. The Relativity between urinary podocyte surface marker protein (PCX) and 24hUpro:The results show that with the reduce of urinary podocyte surface marker protein (PCX),24Upro reduced also (r=0.526, P=0.003), it shows that there is a positive correlation between urinary podocyte surface marker protein(PCX) and 24Upro.Conclusions(1)DaHuangFuZiXiXin Decoction has certain function in delaying the development of chronic renal failure and improving the patient's clinical symptoms, raising the patient's quality of life. The effect of high dose group is obviously, the clinical effect of DaHuangFuZiXiXin Decoction has certain relationship with the therapeutic dosage in treating chronic renal failure.(2)Middle and high dosage of DaHuangFuZiXiXin Decoction has certain function in reducing podocyte injury in patients of chronic renal failure. |