| ObjectivesChooseing the patients fitting CKD stage 2 to 5,and their TCM syndrome belonged to spleen and kidney two falsely,and blood stasis and turbidity toxin resistance type,and observing the clinical efficacy on them with Xueshuantong injection added to traditional Chinese medicine prescription,and observing the effect on type Ⅳ collagen protein(Col-Ⅳ)and laminin(LN)meanwhile.Then exploring the therapeutic mechanisms of CKD with this clinical research,and seeking the effective ways of improving renal function and delaying the development of CKD.Methods1.Data sources: selected 84 cases of patients in hospital of Hubei Province Hospital of Traditional Chinese Medicine nephrology durring the period of February 2015 to February 2017.The patients were all diagnosed as CKD2 to 5,and the TCM syndrome belonged to spleen and kidney two falsely,and blood stasis and turbidity toxin resistance type.The patients were divided into 2 groups according to the randomization principle: Xueshuantong injection combined with basic Chinese medicine treatment group(referred to as treatment group)and Alprostadil injection treatment group(referred to as control group).2.Therapeutic methods: on the basis of limiting the diet,regulating blood lipid,reducing blood pressure,correcting acid-base imbalance and electrolyte imbalance,correcting anemia and other conventional treatments,giving the treatment group xueshuantong injection(freeze-dried)combined with oral traditional Chinese medicine(Astragalus,Codonopsis pilosula,Rehmannia,Chinese yam,Cornus,Poria cocos,Salvia,Radix Angelicae Sinensis,Atractylodes Rhizome,Cucumber Peel,Coix Seed,Achyranthes bidentata,Rhubarb),and giving the control group Alprostadil injection.The total course was 2 weeks.3.Observation index: observing the two groups’ before and after treatments of clinical symptom integral,serum creatinine(Scr),blood urea nitrogen(BUN),glomerular filtration rate(e GFR),24-hour urine protein(24hUPQ),hemoglobin(HB,serum albumin(ALB),type Ⅳ collagen protein(Col-Ⅳ),Laminin(LN)and other indicators,along with some safety indicators,such as liver function,electrocardiogram,routine of blood,urine and stool,fecal occult blood,electrolyte and so on,while laterally comparing the differences of efficacy between the stages of CKD on treatment group.4.Statistical analysis: all clinical trial data was established a data and using the SPSS statistics 19 to analyze them.All the measurement data was represented with(x ±s),and the measurement data and numeration data were statis tically analyzed with t-test and X2-test respectively.Comparing each experimental index with Mann-Whitney U test.If P<0.05,signifying its has statistically difference,to the contrary,if P>0.05,meaned there was no statistically difference.P<0.01 said there was a statistically significant difference.Results1.Comparison of the curative effect on the two groups before and after treatment: the total effective rate of the treatment group was 88.10%,and the control group was 76.19%.There was no significant difference in the curative effect between the two groups(P>0.05).2.Comparison of TCM clinical efficacy before and after treatment: in terms of TCM Syndromes efficacy,the total efficiency of the treatment group was 90.48%,and its better than the control group which was 64.29%(P<0.05);in the aspect of the TCM clinical symptom scores,compared with the group before treatment,the treatment group symptom scores decreased significantly(P<0.01),and the control group symptom scores decreased(P<0.05),and the treatment group was better than the control group after treatment(P<0.01);in the aspect of the main symptoms,the two groups were both having curative effect in the improvement of shortness of breath,lassitude,soreness and weakness of waist and knees,poor appetite,body weight,complexion dark,low back pain,and the treatment group was better than the control group(P<0.05).3.Comparison of renal function on two groups before and after treatment: compared with before treatment,the two groups both could reduce Scr and improve eGFR(P<0.01),and could reduce BUN(P<0.05).The treatment group was better than the control group(P<0.05).4.Comparison of 24 hUPQ,HB,ALB before and after treatment in two groups: the HB of two groups were both higher than before,and the effect of the treatment group was better than the control group(P<0.05);after treatment,the 24 hUPQ of treatment group was lower than before,and the control group was no obvious changes,and the curative effect of the treatment group was better than the control group(P<0.05);after treatment,the ALB of treatment group was elevated,and the control group had no obvious change,and the two groups had no significant difference(P>0.05).5.Comparison of serum Col-IV and LN before and after treatment in two groups: the serum Col-IV,LN of treatment group was lower than before after treatment(P<0.05),and the control group had no ignificant change after treatment(P>0.05);compared this two groups after treatment,the treatment group was better than the control group(P<0.05).6.The treatment group had some differences of curative effects between the different stages of CKD on improving renal function.The efficacy of BUN was no significant difference in each period(P>0.05);in terms of Scr and e GFR,the clinical efficacy had statistically differences between each stage(P<0.05),and based on the statistical analysis,the effect of CKD stage 3 and 4 were better than the stage 2 and 5.7.Analyzing the safety indicators in the before and after treatment for the treatment group and control group,the liver function,electrocardiogram,routine of blood,urine and stool,fecal occult blood,electrolyte and so on were all no significant differences(P>0.05);and there were no adverse reactions during the treatments.ConclusionsTreating the patients on stage of CKD2 to 5 and the TCM syndrome belonged to spleen and kidney two falsely,and blood stasis and turbidity toxin resistance type with Xueshuantong injection combined with traditional Chinese medicine prescription,can significantly relieve their clinical symptoms,improve the renal function,reduce its serum Col-Ⅳand LN,proteinuria and rise its hemoglobin and serum albumin.Analyzing its mechanism may be through improving the renal microcirculation,improving the GFR,retarding the interstitial fibrosis,and then effectively delaying the development of CKD.In addition,on the aspect of improving renal function with this method,the CKD stage 3 and 4 may be more effective than CKD stage 2 and 5. |
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