| Objective:In this study,clinical symptoms,residual renal function,quality of life and clinical indexes were measured for the purpose to study the therapeutic effect and its effect on the quality of life of Shengqingjiangzhuo capsule in the treatment of patients with chronic renal failure(CRF),so as to comprehensively evaluate of the clinical efficacy of Shengqingjiangzhuo capsule.At the same time,to determine whether the capsule can improve peritubular capillaries and explore the mechanism of the capsule to alleviate or delay renal fibrosis.Method:The enrolled patients with CRF in this study were came from the First Affiliated Hospital of Guangzhou University of Chinese Medicine.This was a prospective,randomized,controlled clinical trial performed in a single center.Patients of CRF were randomly divided into treatment group and control group according to 1:1 enroll ratio.The control group received routine treatment,whereas the treatment group received additional Shengqingjiangzhuo capsule(5 capsules/times,3 times/day),and all the patients were treated for 4 weeks.Monitored indicators and point:traditional Chinese medical symptom score,clinical efficacy and safety index were evaluated at baseline and at 28 days.The quality of life was evaluated at baseline and at 4 weeks.The level of HIF-1 ??VEGF?TSP-1?TL-6?IL-8 and EPCs were assessed at baseline and at the 1st,14th and 28th day after treatment.Results:1.Baseline comparison:The analysis of this study on the primary diseases showed that the incidence rate of chronic glomerulonephritis was 56.25%,followed by chronic renal failure caused by metabolic syndrome such as diabetes and hypertension.At the age of 41 to 60 years,the incidence rate was the highest.Gender ratio of male to female was 1.05 to 1.2.Traditional Chinese medical symptom score:After treatment,the traditional Chinese medical symptom score of two group patients were both improved(P<0.05).Compared with control group,the improvement of TCM syndrome score in treatment group was more obvious(P<0.05),and the difference in treatment group was more significant before and after treatment(P<0.01).3.Renal function:After treatment,the changes of Scr?BUN and Ccr in the treatment group were significantly different(P<0 01).However,the changes of Scr and Ccr in the control group were statistically significant(P<0.05).Compared with the control group,there were significant differences in the changes of Scr and Ccr in the treatment group(P<0.01),and there was no significant difference in BUN between the two groups after treatment(P>0.05).4.Clinical indexes of CRF:After treatment,the changes of Hb?K?Ca?P?PTH and 24 hour urine protein quantity in the treatment group were significantly different(P<0.01).The changes of Hb?Ca?P?PTH and 24 hour urine protein quantity in the control group were statistically significant(P<0.05).Compared with the control group,there were significant differences in the changes of PTH in the treatment group(P<0.01),there were statistically significant in the changes of Hb?Ca and P(P<0.05),and there were no significant difference in K and 24 hour urine protein quantity between the two groups after treatment(P>0.05).5.The quality of life:The quality of life of patients with CRF can be improved after treatment,the total score of SF-36 in the treatment group was significantly increased(P<0.01).Analyzed from the dimensionality of SF-36,the scores of 'Physical functioning','Physical Role','Health condition','Energy state','Emotional state' and'Emotional functions' were significantly different compared with before treatment in treatment group(P<0.01),the scores of 'Body pain' and'Social function' were statistically significant(P<0.05).The scores of'Social function' was significantly different compared with before treatment in the control group(P<0.01).The scores in the other 7 dimensionalities were higher than those before treatment,but there was no significant difference(P<0.05).Comparison between groups via D-value of SF-36 scores and every dimension score showed that,there were statistically significant in the scores of 'Physical functioning','Physical Role','Emotional functions' and SF-36 scores(P<0.05),there was significantly different in the scores of 'Health condition'.6.Correlation analysis:The SF-36 scores(r=0.241,P=0.031)and Ccr(r=0.281,P=0.011)showed a significant positive correlation with EPCs.The traditional Chinese medical symptom score r=-0.270,P=0.015),Scr(r=-0.298,P=0.007)and BUN(r=-0.277,P=0.013)showed a significant negative correlation with EPCs.There was no linear correlation between 24 hour urine protein quantity and EPCs.VEGF(r=0.251,P=0.025)showed a significant positive correlation with EPCs.TSP-1(r=-0.339,P=0.002),IL-6(r=-0.257,P=0.021)and IL-8(r=-0.247,P=0.027)showed a significant negative correlation with EPCs.HIF-1 ?(r=0.357,P=0.001)showed a significant positive correlation with VEGF,TSP-1 r=-0.267,P=0.016)showed a significant negative correlation with VEGF.IL-6(r=0.303,P=0.006)and IL-8(r=0.236,P=0.035)showed a significant positive correlation with TSP-1.7.HIF-1 ?:The level of HIF-1? was no significant difference(P>0.05)between treatment group and control group at the point of 14th day after treatment.To the 28th day,there was significant difference(P<0.05)in the two groups.At the point of 28th day after treatment,the level of HIF-1 ? was significant difference(P<0.01)compared with before treatment in treatment group,while there was no significant difference(P>0.05)in the control group.8.VEGF:The level of VEGF was no significant difference(P>0.05)between treatment group and control group at the point of the 14th day after treatment.To the 28th day,there was significant difference(P<0.05)in the two groups.In treatment group,the improvement of the level of VEGF at the 14th day and 28th day were significant(P<0.05)compared with before treatment.In the control group,there was significant difference(P<0.05)only at the 28th day compared with before treatment.9.TSP-1:Although the level of TSP-1 decreased,there was no significant difference(P>0.05)at the 14th day after treatment.To the 28th day,there was significant difference(P<0.05)in the two groups.In treatment group,the decline of the level of TSP-1 at the 14th day and 28th day were significant(P<0.05)compared with before treatment.In the control group,there was significant difference(P<0.05)only at the 28th day compared with before treatment.10.IL-6:Although the level of IL-6 decreased,there was no significant difference(P>0.05)at the 14th day after treatment.To the 28th day,there was significant difference(P<0.05)in the two groups.In treatment group,the decline of the level of IL-6 at the 14th day and 28th day were significant(P<0.05)compared with before treatment.In the control group,there was significant difference(P<0.05)only at the 28th day compared with before treatment.11.IL-8:Although the level of IL-8 decreased,there was no significant difference(P>0.05)at the 14th day after treatment.To the 28th day,there was significant difference(P<0.05)in the two groups.In treatment group,the decline of the level of IL-8 at the 14th day and 28th day were significant(P<0.05)compared with before treatment.In the control group,there was significant difference(P<0.05)only at the 28th day compared with before treatment.12.EPCs:The level of EPCs was no significant difference(P>0.05)between treatment group and control group at the point of the 14th day after treatment.To the 28th day,there was significant difference(P<0.05)in the two groups.In treatment group,the improvement of the level of VEGF at the 28th day was significant(P<0.05)compared with before treatment.In the control group,there was no significant difference compared with before treatment(P>0.05).Conclusion:Shengqingjiangzhuo capsule can effectively improve the TCM symptoms,the quality of life of patients and renal function,correct metabolic disorders of calcium and phosphorus,regulate triglyceride levels and improve a.nemia.Circulating EPCs,the evaluation index of PTC,correlate with renal function and clinical symptoms in patients with CRF.The mechanism of Shengqingjiangzhuo capsule on protecting renal may be achieved by promoting the high expression of VEGF to mediate EPCs mobilization and inhibiting by multi target and pathway cascade reaction,which inhibiting the over expression of TSP-1?IL-6 and IL-8 to weaken the inflammatory reaction and promote the regeneration of renal tubular capillaries,finally improve PTC and renal fibrosis. |
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