| Objective:Through clinical and experimental research, to verify the clinical efficacy of Yi Shen Hua Yu Recipe, clarify the part mechanism of Yi Shen Hua Yu Recipe,and provide scientific theory and practice for clinical application.Methods: The clinical part: The 60 selected patients in this study come from the First Affiliated Hospital Henan University of Traditional Chinese Medicine Department of internal medicine outpatient and inpatient nephropathy, and they are with chronic kidney disease(CKD) 2-4 diagnostic criteria of Western medicine and TCM syndrome of kidney deficiency and blood stasis type standard from April 2013 to October 2014. The 60 patients were randomly divided into two groups and each group was 30 cases.The two goups were Yishen Huayu Decoction treatment group and conventional treatment of Western medicine control group. The two groups were treated by routine western medicine but the treatment group added Yishen Huayu Recipe in the control group based on the treatment scheme. A period of treatment is 4 weeks and the two groups of patients are treated for 3 periods. Before and after 12 weeks treatment, all the patients need the examination of serum creatinine, blood urea nitrogrn and uric acid,creatinine clearance rate,blood routine,stool routine,liver function, electrocardiogram, signs of TCM syndrome score, quality of life scores of patients and make the assessment of curative effect. The experimental research part:rats with unilateral ureteral ligation of renal interstitial fibrosis(UUO) model is established. 162 male SD rats were randomly divided into 6 groups: the control group, model group, Yi Shen Hua Yu Recipe in the high dose treatment group, Yi Shen Hua Yu Recipe in the middle dose treatment group, Yi Shen Hua Yu Recipe in the low dose treatment group, valsartan capsule treatment group, each group is 27. All the rats are used the left side ureteral ligation to establish UUO model except fake surgery group, and all the groups of rats were filled the stomach the next day, the fake surgery group, model group to saline 20ml/Kg?d to fill the stomach, Yi Shen Hua Yu Recipe in the high, middle, low dose group were 32g/Kg?d, 16g/Kg?d, 8g/Kg?d, dosing volume of 20 ml/Kg?d,the valsartan capsule treatment group is 13.3mg/Kg?d lavage, dosing volume for 20ml/Kg?d. After the treatment of 4 weeks, 8 weeks, 12 weeks, all the groups of rats was detected in serum creatinine(SCr), blood urea nitrogen(BUN), urinary inhibition C(Cys C) the change of the index.Application of enzyme linked immunosorbent assay(ELISA) method to detect each rat’s kidney transforming growth factor beta 1(TGF-β1), the expression of interleukin 6(IL-6). Results: Clinical observation:(1) 60 patients with CKD2-4 before treatment, SCr, BUN and CCr between treatment group and control group were no difference(P> 0.05).(2) The treatment group total effective rate was 93.33% and the control was 80.00%, compared the two groups of curative effect was statistically significant(P< 0.05).(3) The clinical observation results show that the two groups all can reduce the SCr, BUN, raise the CCr, and the results of the treatment group is better than those of control group(P<0.05). But the two groups of UA, before and after the treatment is no significance(P>0.05).(4) After the treatment, the TCM symptom score of the treatment group and the control group was obviously decreased, the difference was statistically significant(P<0.05).(5)The determination of two groups of patients in the world health organization quality of life scale short form(WHOQOL BREF) total score was statistically significant(P<0.05).(6)The treatment group of patients electrocardiogram(ecg), blood routine, stool routine, liver function had no adverse effects, and no obvious adverse drug reactions in the treatment.The experimental study:(1) Yi Shen Hua Yu Recipe on UUO model rat renal effects: compared with the fake surgery group, model group rats Scr, BUN, elevated levels of Cys C, apparent, and with the increase of time point level gradually increase(P<0.01); Compared with the model group, Scr, BUN, each dose group rats Cys C decreased obviously, and Yi Shen Hua Yu Recipe in high-dose group and valsartan group fell the most obvious(P<0.01), between the two groups has no statistical significance(P>0.05).(2) Yi Shen Hua Yu Recipe in renal tissue in rat UUO model of TGF-β1, IL-6 expression changes: Compared with model group, the same point in time each dosage group rats TGF-β1 content in kidney tissues were significantly reduced(P<0.01), the same point in time the dosage groups of rats in addition to the kidney blood party low dose group, the content of IL-6 in renal tissue were significantly reduced(P<0.01 or P<0.01); Dosage groups each rat kidney tissue at different time points in the expression of TGF-β1, IL-6 were lower than the model group, And Yi Shen Hua Yu Recipe in high do- se group and valsartan capsule treatment group have the most significant effect, no difference between the two groups(P>0.05).Conclusion: 1 、 The clinical observation: The Yi Shen Hua Yu Recipe in the treatment of CKD2-4 can effectively improve the patients with lumbar debility, languid, waist pain, chills, afraid of the cold and other clinical symptoms, reduce the SCr, BUN, increases the CCr level, improve the quality of survival in patients and confirmed Yi Shen Hua Yu Recipe can delay the progress of chronic kidney disease(CKD);2、Experimental study: The Yi Shen Hua Yu Recipe can effectively reduce the UUO model rats serum levels of Scr, BUN, Cys C level,also can effectively inhibit the rat kidney tissue expression of TGF-β1 and IL-6, Show that The Yi Shen Hua Yu Recipe may be through the inhibition of TGF-β1 and IL-6 in the renal tissue of the expression, reduce the degree of renal fibrosis, thus play a role of kidney protection. |
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