| 1 Objective To observe the curative effect of Jianpi Xiezhuo method in patients with early gouty nephropathy,and its effect on Kim-1 and NGAL expression.To elucidate the relationship between Kim-1 and NGAL with early gouty nephropathy,and to explore the intervention mechanism of Jianpi Xiezhuo method on early gouty nephropathy.2 Method2.1 Theoretical research Through a large number of literature searches and studies,analyzes the relationship between gout and kidney damage,and TCM spleen deficiency and dampness stagnation,To summed up the etiology and pathogenesis of early gouty nephropathy with traditional Chinese medicine.clarify the mechanism of traditional Chinese medicine for treating early gouty nephropathy with Jianpi Xiezhuo method.2.2 Clinical studies2.2.1The changes and correlation of urine Kim-1 and NGAL in patients with early gouty nephropathy :To observe 40 cases of early gouty nephropathy age,gender,disease duration,BMI,TCM syndrome value,quality of life(Short Form-36,SF-36),anxiety and Depression Scale(SAS,SDS)score,visual analogue scale,serum creatinine(CREA),urea nitrogen(BUN),serum uric acid(UA),glomerular filtration rate(e GFR),24 hours urinary protein quantity(24h PRO),urine protein series,blood lipids,blood glucose,inflammation index and other laboratory indicators.Randomly selected 20 physical examination personnel which came from the physical examination center of Anhui Provincial Hospital of Traditional Chinese Medicine as the healthy control group.The gender,age of the control group matched with the early gout nephropathy.We used ELISA kits to detect changes of Kim-1 NGAL in the healthy control group and the patients with early gout nephropathy,and also detected other laboratory indicators in early gout nephropathy patients:24 hours urinary protein quantity,high sensitive C reaction protein(hs-CRP),erythrocyte sedimentation rate(ESR),Cystatin C(CysC), blood uric acid(UA),Blood glucose and blood fat series,urine protein series,urinary albuminto-ereatinine ratio(ACR),urinary total protein creatinine ratio(TCR),glomerular filtration rate(e GFR)were calculated.The TCM syndrome value,visual analogue scale,SAS score,SDS score,life health questionnaire(SF-36)were observed.SPSS 22.0statistical software was used to analyze the changes of Kim-1,NGAL and the above indexes before and after treatment.2.2.2 Studies of Clinical efficacy:40 cases of early gouty nephropathy patients were randomly divided into study group(Jianpi Xiezhuo granules + Febuxostat Tablets)and the control group(Febuxostat Tablets)by each of the 20 cases.The Kim-1,NGAL,24 hours urinary protein quantity,CRAE,BUN,UA,CysC,hs-CRP,ESR,GLU,TG,T-CHOL,LDL-C,HDL-C,urine protein series,ACR,TCR of two groups were detected.The changes TCM syndrome value,visual analogue scale,SAS score,SDS score,life health questionnaire(SF-36)were observed.SPSS22.0 statistical software was used to analyze the changes of urinary Kim-1 and NGAL and the above indexes before and after the treatment.3 Results3.1 Theoretical results3.1.1 urine Kim-1 NGAL may be used as a marker of early renal damage in gout.3.1.2 TCM syndrome of due to spleen,kidney deficiency and mutual formation of dampness and turbid phlegm and blood stasis are the basic etiology and pathogenesis of early gouty nephropathy.3.1.3Jianpi Xiezhuo formula as a therapeutic method of traditional Chinese medicine which plays a key role in the treatment of early gouty nephropathy.3.2 The results of clinical studies3.2.1 The studies on the change and correlation of urinary Kim-1 NGAL in early gouty nephropathy patients.The urine levels of Kim-1 and NGAL were significantly higher in early gouty nephropathy patients compared with healthy control group.(P<0.01).The urine levels of Kim-1 was positively correlated with age and disease duration in early gouty nephropathy patients(P<0.01),the urine NGAL level was positively correlated with age and disease duration in early gouty nephropathy patients(P<0.05 or P<0.01),serum CysC was positively correlated with disease duration(P<0.01).There were no significant correlation between Kim-1,NGAL and CysC with BMI.Early gouty nephropathy patients urine Kim-1 was positively correlated with CREA,BUN,UA(P<0.05 or P<0.01),and negatively correlated with e GFR(P<0.05);urine NGAL was positively correlated with CREA,BUN,UA(P<0.05 or P<0.01);urine NGAL was negatively correlated with e GFR(P<0.05);serum CysC was positively correlated with CREA,BUN,UA(P<0.05 or P<0.01);serum CysC was negatively correlated with e GFR(P<0.05).Urine Kim-1 and NGAL were positively correlated with TRFU,ALBU,?1-MG,?2-MG,ACR and TCR in patients with early gouty nephropathy(P<0.05 or P<0.01),and there was no significant correlation between Kim-1,NGAL with IGGU in early gouty nephropathy patients.The serum CysC were positively correlated with ALBU??1-MG??2-MG?ACR?TCR in early gouty nephropathy patients(P<0.05 or P<0.01),and there was no significant correlation with IGGU and TRFU.The joint pain of the early gouty nephropathy patients was positively correlated with the Kim-1,NGAL and CysC(P<0.01).Joint swelling was positively correlated with Kim-1,NGAL,CysC(P<0.05 or P<0.01).The flexion and extension of the joint was positively correlated with NGAL(P<0.05),but no significant correlation with Kim-1 and CysC.Gout stone was positively correlated with the Kim-1,NGAL and CysC(P<0.05 or P<0.01).Joint heavy was positively correlated with the Kim-1,NGAL and CysC(P<0.05 or P<0.01).Mental exhaustion was positively correlated with the Kim-1(P<0.01),but no significant correlation with NGAL,CysC.The urine level of Kim-1 was positively correlated with VAS score,SDS score and quality of life GH,PF,RP,SF,BP,VT and MH(P<0.05 or P<0.01).NGAL was positively correlated with VAS score,SAS score,GH,PF,RP,RE,SF,BP and VT(P<0.05 or P<0.01).CysC was positively correlated with VAS score and PF,RP,SF,BP,VT,MH(P<0.05 or P<0.01).There was no significant correlation between SDS score with Kim-1,NGAL,and CysC.Kim-1 and CysC were not associated with RE,CysC was not associated with VT.NGAL was not associated with MH.The urine levels of Kim-1 was positively correlated with hs-CRP,ESR and 24 h PRO in patients with early gouty nephropathy(P<0.01),The urine levels of NGAL was also positively correlated with hs-CRP,ESR and 24 h PRO in patients with early gouty nephropathy(P<0.01),The serum level of CysC was positively correlated with hs-CRP ESR and 24 h PRO(P<0.01 or P<0.05).3.2.2 Clinical efficacy on the treatment of early gouty nephropathy with Jianpi Xiezhuo formula The total effective rates of the two groups after treatment were 85.00% and 75.00%,no statistically significant difference(P(29)0.05).However,the clinical cure rate of treatment group(35.00(4))was significantly higher than the control group(10.00(4))(P<0.05).3.2.3 The effect of Jianpi Xiezhuo formula on Kim-1 NGAL and CysC in patients with early gouty Nephropathy After treatment,the Kim-1,NGAL and CysC of the two groups were significantly lower than those before treatment(P<0.01).The treatment group was significantly better than the control group in reducing Kim-1,NGAL and CysC(P<0.05 or P<0.01).3.2.4 The effect of Jianpi Xiezhuo formula on CREA,BUN,UA and GFR in patients with early gouty Nephropathy.After treatment,the CREA,BUN and UA were significantly decreased in both groups(P<0.01),and e GFR increased significantly(P<0.01).After treatment,the treatment group was significantly better than the control group in reducing BUN and UA(P<0.05 or P<0.01).3.2.5The effect of Jianpi Xiezhuo formula on hs-CRP,ESR and 24 h PRO in patients with early gouty Nephropathy.After treatment,the hs-CRP,ESR and 24 h PRO of the two groups were decreased significantly(P<0.01),The treatment group was significantly better than the control group in reducing hs-CRP,ESR and 24 h PRO(P<0.05 or P<0.01).3.2.6The effect of Jianpi Xiezhuo formula on urine protein series,ACR and TCR.The IGGU,ALBU,a 1-MG,b 2-MG,ACR and TCR of the treatment group were significantly lower than that before treatment(P<0.05 or P<0.01).After treatment,the IGGU,ALBU,?2-MG,ACR and TCR of the control group were significantly lower than before treatment(P<0.05 or P<0.01).The treatment group was significantly better than the control group in reducing ALBU,?2-MG,ACR,TCR(P<0.05 or P<0.01).TRFU in the treatment group and TRFU,a 1-MG in the control group were not significantly changed after treatment in the two groups.3.2.7 The effect of Jianpi Xiezhuo formula on blood glucose and blood lipid in early gouty Nephropathy patients.After treatment,the serum levels of GLU,TG,T-CHOL and LDL-C in the treatment group were significantly decreased than those before treatment(P<0.01),The HDL-C of treatment group of there has obvious change,besides,there were no significant changes of blood glucose and blood lipid in control group.After treatment,the GLU,TG,T-CHOL and LDL-C in the treatment group were significantly lower than those in the control group(P<0.05 or P<0.01),HDL-C had no significant changes in the two groups after treatment.3.2.8 The effect of Jianpi Xiezhuo formula on TCM syndrome value.The TCM syndrome value of two groups had no significant difference before treatment(P(29)0.05).After treatment,the TCM syndrome value of the two groups reduced significantly(P<0.01).The treatment group was more effective in improving joint pain,joint swelling,gout stone and mental exhaustion than the control group after treatment(P<0.05 or P<0.01).Meanwhile,the two groups had no significant difference when improving the flexion and extension of the joint and joint heavy(P(29)0.05).3.2.9 The effect of Jianpi Xiezhuo formula on VAS scores,anxiety and depression scores,quality of life scores.The VAS scores,anxiety and depression scores,quality of life scores of two groups had no significant difference before treatment(P(29)0.05).After treatment,VAS score of both groups were significantly lower(P<0.01),The SDS and SAS score of the treatment group were significantly lower than that before treatment(P<0.05 or P<0.01),the quality of life in each dimension GH,RF,RP,RE,SF,BP,VT,MH levels were elevated(P< 0.01);The levels of GH,RF,RP,RE,SF,BP,VT and MH of the control group were significantly increased than before treatment(P<0.01),and there was no significant change in SDS and SAS levels.After treatment,The treatment group was significantly better than the control group in reducing VAS and SAS score(P<0.05 or P<0.01),The treatment group was significantly better than the control group in increase GH,RE,SF and MH(P<0.05 or P<0.01).4 Conclusion4.1The levels of urinary Kim-1 and NGAL were significantly increased in early gout nephropathy patients.The Kim-1 and NGAL in early gout nephropathy patients were closely related to age,disease duration,UA and kidney damage,and was negatively correlated with GFR.The Kim-1 and NGAL were closely related to joint symptoms and inflammation index.4.2Jianpi Xiezhuo formula can significantly reduce the level of Kim-1 and NGAL,and inhibit the Kim-1 and NGAL high expression.4.3Jianpi Xiezhuo formula can effectively reduce the level of CREA,BUN,UA,IGGU,ALBU,?1-MG,?2-MG,ACR,TCR and 24 h PRO.which can improve the renal function of patients.4.4Jianpi Xiezhuo formula can effectively reduce the level of hs-CRP,ESR and other inflammatory indicators.Alleviate the pain of the patient.4.5 Jianpi Xiezhuo formula can effectively relieve the patient's joint pain,swelling and gout stone and other general body joint symptoms,and has the effect of strengthening spleen and removing turbid.It can improve patient's physical and mental health,improve patient quality of life.4.6The possible pathogenesis of Jianpi Xiezhuo formula on treatment for early gout nephropathy is the result of chronic hyperuricemia and inflammatory stimulation.In the urine,Kim-1 and NGAL are the indicators of sensitivity and specificity of acute and chronic renal damage,which can accurately reflect the degree of damage of glomerular filtration function.The elevated levels of Kim-1 and NGAL in the urine of patients with gout may be a compensatory preventive measure in the state of renal injury.Jianpi Xiezhuo formula has a downward effect for serum uric acid levels and inflammation index,downward effect for Kim-1 and NGAL,so as to alleviate the kidney damage,improve renal function,improve the patients quality of life. |
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