| Chronic kidney disease (CKD) is a group of progressive development of chronic non-infectious diseases, with a high prevalence of high cardiovascular disease complications, high mortality rates and high consumer characteristics, both developed and developing countries are facing serious challenges. Enhance early diagnosis, monitoring and prevention of CKD, delay CKD to end-stage renal disease (ESRD), progress on global public health field has an important significance. Intervention of CKD early and middle stages, and to intervene than to end stage renal failure, patients will get a better prognosis, this view has been the support of substantial evidence. In recent years, nephrology international community concerns has transferred from chronic renal failure(CRF) and its replacement therapy by this "tip" to its hidden tremendous base-CKD.For delaying the development of CKD at present, the effect of western medicine treatment alone is still very limited. But traditional Chinese medicine has obvious advantages in the treatment of the CKD stage2-4; which features as treatment determination based on syndromes differentiation and adjusting the dynamic balance of the human body, and its therapeutic effect in many multi-level and multi-element aspects is more adapted to the treatment of CRF involved with the many symptoms, and has important significance for stabling renal function and delaying the further development of renal damage. In Traditional Chinese Medicine (TCM), CRF is diagnosed as “Shui Zhong”,“Guan Ge”,“Long Bi”,“Ni Du”,“Xu Lao”, The pathogenesis of prophase and metaphase of CKD is Qi-deficiency of the spleen and kidney and intermingled state of turbid phlegm and blood stasis. And the deficiency of the spleen and kidney is the root of the disease, intermingled state of turbid phlegm and blood stasis is the sign of the disease. In recent years, Chinese medicine has made substantial progress in the slow CKD progression and improve renal function and delay the time to enter the renal replacement, and improve patients’ clinical symptoms, and improve their quality of life, more and more attention.Objective:Evaluation of JPYSHYJZ particle to slow the progress of chronic renal failure, JPYSHYJZ particle and valsartan capsules CKD2-3in spleen and kidney Qi combination therapy, the efficacy and safety of wet muddy stasis provide a basis for clinical application.Methods:60cases were included with primary glomeru-lopathy and CKD2-3. They were randomly divided into two groups:JPYSHYJZ particle (test group, JPYSHYJZ particle+valsartan capsules simulation), combined group(control group, valsartan capsules). According to TCM syndromes of the patients, the therapy is routine treatment combined with relevant treatment of TCM. The scores of TCM syndromes and laboratory index were observed at0,4th,8th,12th week. To evaluate of the therapeutic efficacy, some indexes were used, including the24hours urinary protein and Blood Urea Nitrogen BUN), Scrum Creatinine (Scr), Scrum albumin(Alb), hemoglobin (Hb), Scrum Calcium (Ca2+), Scrum Phosphate (P3+) and the efficacy(changes of Traditional Chinese medical syndrome) and side effects were assessed at the very beginning of the trials,4th,8th and12th weeks later respectively. Target for the safety of blood, urine, stool occult blood add routine, liver function (ALT, AST), electrolyte (K+, Na+, Cl-), electrocardiogram. Statistic analysis.-All values are expressed as the mean±standard deviation(x±s). Statistical analysis was performed using the statistical package SPSS for Windows Ver.13.0. Results of prior-treatment and post-treatment in the group were analyzed using paired t test. Independent two-sample t test was used for the comparison of the two groups before and after treatment. If there was heterogeneity of variance, independent two-sample t test was used. Count data was analyzed by Pearson χ2test, level data with the Wilcoxon W rank sum test. P<0.05was considered to be statistically significant.Results:1. One cases of the experimental group shed and29cases included in analysis. Two cases of the control group shed, and28cases included in analysis. Finally57cases enter the analysis of results in two groups.2. After12weeks’ treatment, BUN levels of both groups reduced compare with the pre-treatment, BUN of the test group was statistically significant (t=2.267, P=0.031) compared with before treatment, but the BUN of the control group dropped with no significant difference (t=1.476, P=0.151), the difference between two groups was not statistically significant (t=-0.189,P=0.798); Scr of the test group decreased significantly than the pre-treatment (t=3.599, P=0.001), the control group Scr was higher than before treatment, the difference was statistically significant (t=-2.574, P=0.016) after12weeks of treatment in both groups, the difference was significant (t=-1.833,P=0.001).3. In the12th week, eGFR of test group had an obvious increase than the beginning of the trail (t=-6.543,P=0.000), while the eGFR of the control group decreased with no statistical meaning(t=1.937, P=0.063); the difference between two groups was statistically significant(t=2.103, P=0.011).4. The24hours urinary protein decreased significantly in the experimental group after12weeks’treatment (t=2.311, P=0.028), while the control group decreased with no statistical meaning(t=1.409, P=0.170), the difference between the two groups was significant (t=-3.485, P=0.000).5. After12weeks of treatment than before treatment, control group Hb decrease was statistically significant (t=2.962, P=0.006); test group12weeks after the intervention than before treatment tended to increase, but not statistically significant (t=-1.884, P=0.070), treatment in both groups after12weeks the difference was statistically significant (t=2.860, P=0.022).6. With the extension of the course, two sets of Alb compared with before treatment were decreased in the control group after12weeks of treatment, Alb decreased significantly (t=2.477, P=0.021); Alb decreased in the treatment group after12weeks, no statistical significance (t=1.062, P=0.297), the difference was not statistically significant (t=-0.118, P=0.258).7. The efficacy(changes of traditional Chinese medical syndrome) of test group compared with the control group had no statistically significant difference (t=-1.447, P=0.148)8. In adverse events, one of the experimental group had a hyperkalemia after12weeks’treatment. There were no other adverse reactions in the trial period.9.12weeks after treatment, the blood Ca2+and blood P3+level were stable of both the experimental group and control group compared with before treatment, and showed no significant differences (P>0.05).Conclusion:JPYSHYJZ particle can significantly decrease the BUN and Scr, improve anemia and TCM symptom of CKD2-3stages with spleen and kidney Qi deficiency, dampness stasis, and significantly decreased24h-urinary protein, to make the greatest possible protection of renal function, delay disease progression, with advantages of light side effects and high safety. |
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