| Objective:To analyze the effect of Qikui particles on blood glucose,blood fat,urine ACR,24h urine protein quantitation and renal function as well as urine podocyte associated protein PCX and Nephine level by clinical study in early diabetic nephropathy of the patients with Type 2 diabetes.Meanwhile,to observe the effects of Qikui particles with different dosages on rat renal podocyte associated protein PCX and Nephine level and homaluria by combining with in vivo animal experiment in order to explore its renal protective mechanism of Qikui particles as proteinuria reduction.Methods:1 Clinical study:this study was a randomized parallel-controlled trail.112 patients with early DN were collected and separated into two groups,including control group with 56 cases and Qikui particles group with 56 cases.In the control group,the patients were treated by basic therapy of western medicine.In the Qikui particles group,the patients were treated by basic therapy of western medicine combined with Qikui particles.During the therapy for six months,the indicators such as blood glucose,urine ACR,24h urine protein quantitation and renal function were detected.The clinical efficacy and safety of Qikui particles were evaluated for early diabetic nephropathy of the patients with Type 2 diabetes identified as qi-yin asthenia and stagnation of phlegm and blood stasis to explore the potential mechanism and identify the effective indicators of traditional Chinese medicine.2 Animal experiment:the effects of Qikui particles on blood glucose,blood fat,creatinine,urea nitrogen,urine protein,urine protein excretion and hepatic function were observed preliminarily through in vivo animal experiment to explore its effect on postponing the development of proteinuria in mice with diabetic nephropathy and its promotion mechanism for PCX and Nephine by upregulating the renal podocyte associated protein PCX and Nephine and improving renal pathology.Hence,to some extent,the Qikui particles can protect the kidney.Results1 Clinical study:(1)Symptom of traditional Chinese science:Qikui particles improved the symptom of traditional Chinese science compared with control group and there was statistical significance(P<0.05).(2)Blood glucose variation:for two groups,FBG,PBG and HbAlc after the therapy were striking lower than those before the therapy with statistical significance(P<0.05).For group comparison,there was no statistical significance for FBG,PBG and HbAlc before therapy and after therapy for eight weeks,sixteen weeks and twenty-four weeks.(3)Blood pressure variation:pre-therapy and post-therapy SBP comparison in control group:138.9± 13.2 vs 126.2±7.3;the comparison in Qikui particles group:137.2± 10.8 vs 128.5±7.5.Pre-therapy and post-therapy DBP comparison in control group:84.3±8.2 vs 79.2±7.4;the comparison in Qikui particles group:85.2±8.4 vs 80.1±7.2.Compared with that before the therapy,the blood pressure in two groups reduced and there was statistical significance(P<0.05).There was no statistical significance between two groups.(4)Blood fat variation:pre-therapy and post-therapy CHO comparison in control group:5.22±0.21 vs 4.88±0.15;that in Qikui particles group:5.43±0.33 vs 4.76±0.31.Pre-therapy and post-therapy TG comparison in control group:2.78±0.59 vs 2.84±0.59;that in Qikui particles group:2.30±0.39 vs 2.28±0.38.For two groups,the post-therapy CHO and TG reduced significantly compared with those before the therapy and there was statistical significance(P<0.05);There was no statistical significance for CHO and TG between control group and Qikui particles group(P>0.01).(5)UACR and 24HUTP:UACR reduced in two groups with no statistical significance compared with that before the therapy(P>0.05);post-therapy 24hU-TP was lower than pre-therapy 24hU-TP in two groups and there was statistical significance(P<0.05).It was 290±53.2 in Qikui particles group and 339.41±60.6 in control group respectively.Compared with that in control group,it extremely reduced in Qikui particles group(P<0.01).(6)BUN and Scr:pre-therapy and post-therapy BUN all reduced in control group and Qikui particles group but there was no statistical significance compared with BUN before the therapy(P>0.05);pre-therapy and post-therapy Scr all reduced in control group and Qikui particles group but there was no statistical significance compared with Scr before the therapy(P>0.05).(7)PCX/Ucr and Nephrin/Uc:pre-therapy PCX/Ucr vs post-therapy PCX/Ucr in control group:64.58± 12.23 vs 39.70±12.48;pre-therapy PCX/Ucr vs post-therapy PCX/Ucr in Qikui particles group:63.27±11.72 vs 29.73±15.49.Pre-therapy Nephrin/Ucr vs post-therapy Nephrin/Ucr in control group:77.43±15.37VS38.42±17.52;pre-therapy Nephrin/Ucr vs post-therapy Nephrin/Ucr in Qikui particles group:76.62±14.85VS29.73±15.49.Compared with those before the therapy,post-therapy PCX/Ucr and Nephrin/Ucr reduced extremely(P<0.01).Group comparison show that there was no statistical significance for pre-therapy PCX/Ucr and Nephrin/Ucr between two groups(P>0.05).After therapy for six months,PCX/Ucr and Nephrin/Ucr reduced significantly in Qikui particles group compared with those in control group(P<0.01)?2 Animal experiment(1)Anti-fatigue time,anoxia tolerance time,anti-imflammatory effect and diuresis were all lengthened compared with those in control group after the administration of high dose,moderate dose and low dose of Qikui particles and there was significant difference(P<0.01),in which the effects in high dose group were more stronger.(2)After administration for eight weeks,serum CHOL,TG,HDL and LDL reduced significantly in different dosages.CHOL,TG,HDL and LDL reduced extremely in high dose group and there was significant difference compared with those in model group(P<0.01).(3)Histopathology show that renal glomerulus and its lesion improved in irbesartan group while the improvement for renal interstitium phlogocyte infiltration and hyperemia was not obvious.In the low dose Qikui particles group,renal glomerulus and its lesion improved slightly and the improvement for other lesions was not obvious.In the moderate group,total renal lesions were relieved,including lightened tubular ectasia,slight renal interstitium phlogocyte infiltration reduction and unconspicuous renal glomerulus improvement.In the high dose group,total renal lesions were relieved,including lightened tubular ectasia,no mesenchymal phlogocyte infiltration,lightened mesenchymal vasocongestion,suggesting that Qikui particles had renal protective effect and it was correlated with the dosage.(4)In the model group,PCX and Nephrin expression in renal tissues were down-regulated.Compared with the model group,PCX and Nephrin expression were up-regulated in irbesartan group.PCX and Nephrin expression were up-regulated in high dose,moderate dose and low dose Qikui particles group,in which the variation was extremely obvious in high dose group.Conclusions:1 Clinical observation show that Qikui particles has favorable efficacy for the patients with early diabetic nephropathy identified as qi-yin asthenia and stagnation of arteries and veins type.It can reduce 24h-UTP and urine podocyte associated protein PCX and Nephine levels.Urine PCX and Nephine can serve as screening indicators of early clinical DN.2 In vivo animal experiment further suggest that it can reduce rat urine protein and up-regulate PCX and Nephrin expression and urine PCX and Nephrin,revealing that it exerts renal protection through preventing podocyte associated protein from injury.3 Pharmacodynamics show that the effects of Qikui particles on anti-fatigue,hypoxia tolerance,anti-inflammatory and blood fat are close correlated with the dosage. |
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