| Objective:(1)Clinical study: To estimate the efficacy and safety of Kuaiwei Tables in treating hyperphosphatemia with Chronic Kidney Disease(G5D,CKD-G5D).(2)Experimental study: In intervention of rats in CKD-G5 D by Kuaiwei Tables,observe the influence of rats’ biochemical indicators in high or low dose of Kuaiwei Tables,explore the efficacy and safety of Kuaiwei Tables in treating hyperphosphatemia with Chronic Renal Failure(CRF)and the relationship between dose and efficacy.Methods:(1)Clinical study: 70 patients who suffered from hyperphosphatemia with maintenance hemodialysis were randomly divided into control group and observation group.All of them were given regular hemodialysis.In addition,patients in control group were given Calcium Carbonate D3,patients in observation group were given Kuaiwei Tables,all of them were treated in a general dose for a month.Observe the levels of Serum Phosphate(Pi),Serumcalcium(Ca),Alkaline Phosphatase(ALP),Parathyroid Hormone(i PTH),calcification of blood vessel and heart valve and so on in two groups before and after treatment.And patients were asked to report any symptoms and side effects during follow-up visit or immediately when this happened,such as digestive tract symptom.(2)Experimental study: 6-weeks male rats were taken five-sixths nephrectomy and given high-phosphorus(phosphorus:1.03%)fodder to complete the models.The reference ranges of biochemical indexs were set according to the 95% confidence interval of those in normal rats.Forty-four rats of CRF were randomly divided into model group,Niaoduqing Grains+ Calcium Carbonate D3(Ca group),Niaoduqing Grains+ low-dose Kuaiwei Tables(low-dose group)and Niaoduqing Grains+ high-dose Kuaiwei Tables(high-dose group).Another 10 rats were fed with normal diet as sham group.Observe the levels of Ca,Pi,ALP,i PTH,SCr,BUN,UA,Ghrelin,SS,SIg A,24 h UP before and after the treatment.After the treatment,the right kidney of rat was taken to observe the change of glomerulus,renal tubules and renal interstitium.Results:(1)Clinical study: 4 weeks after treatment,there were 65 patients in this clinical study,33 patients of them in control group,and32 in observation group.After taken medicine for 4 weeks,there were significant distinction between lowering the level of Pi,ALP and i PTH(P< 0.01)and in increasing the level of Ca(P< 0.01).There was no distinction in above indicators between 2 group before and after treatment(P > 0.05).I n the process of administer,liver function,kidney function were in a stable state,and cardiac valve and vascular calcification had no advanced observed by cardiac ultrasound,so did ECG,routine blood test and stool routine.All patients in two groups finished this study without life threatening complications.One patient in control group suffered severe hypocalcemia and increased the dose of calcium carbonate.Another patient in control group suffered painfully bloated stomachs and regurgitation of sourness and dropped out.3 patients in observation group dropped out,because of loss of appetite,failing to follow doctor’s prescriptions and altering the point of dialysis.(2)Experimental study: The rats model were established by the classical composite factors,and checked up by blood biochemistry to confirm that models was successfully made.There was 10 rats in every group.And 6 rats were died during establishing the model.There was no distinction between model rats(P > 0.05).After 4-week treatment,the level of Pi,ALP and i PTH in Ca group,low-dose group and high-dose group was remarkably down(P < 0.01),but no significant change in Ca(P > 0.05).However,the level of Pi,ALP and i PTH in model group increased slowly(P < 0.01),and Ca decrease(P < 0.05).In terms of renal function,the level of SCr in model groups was increased evidently(P < 0.01),and there were no distinction between Ca group,low-dose group and high-dose group before and after the treatment.In terms of BUN,UA and 24 h UP,both of them increased only in model group(P < 0.01),and there was no distinction in control group,Ca group,low-dose group and high-dose group(P > 0.05).In terms of gastrointestinal indicators,Ghrelin increased a lot in model group(P < 0.01),decreased in Ca group and high-dose group(P < 0.05),and there was no difference in low-dose group(P > 0.05).In terms of gastrointestinal indicators,the level of Ghrelin in model group,Ca group,low-dose group and high-dose group was increased evidently(P < 0.01)compared with control group.After 4-weeks treatment,the level of Ghrelin in control group and model group was increased(P < 0.05),in high-dose group was decreased(P < 0.01),and there was no difference between Ca group and low-dose group(P > 0.05).By the detection of SS,the level of SS in all groups was decreased(P < 0.01)after treatment,and there was no difference between Ca group and low-dose group(P > 0.05).However,the levels of SS in control group,model group and high-dose group were different from those in Ca group and low-dose group(P < 0.01).Among the result,the levels of SS in high-dose group dropped most significantly compared with that before treatment,and that in Ca group,low-dose group and high-dose group drooped more than that in control group and model group(P < 0.01).By the detection of SIg A,the level of SIg A in all groups was increased evidently(P < 0.01)compared with those before treatment,there was significant distinction between the population mean of SIg A between control group,low-dose group and high-dose group(P < 0.01)and there was no difference between model group and Ca group in the level of SIg A and the growth rate of SIg A(P > 0.05).The growth rate of SIg A in model group and Ca group is less than those in control group,low-dose group and high-dose group(P < 0.01),and those in high-dose group increased most(P < 0.01).In terms of pathologic examination,there were tubular ectasia,a large number of inflammatory cells in interstitial space,proliferation of kidney interstitial,structure disordered of renal cortex,and narrowing of renal parenchyma by light microscopy in model group,Ca group,low-dose group and high-dose group.By electron microscopy,there were podocytes swelled,part of foot process coalesced and basement membrance damaged in Ca group,low-dose group and high-dose group.All of those changes are accord with the rats of CRF.And changes in group model changed most between all rats,there was no difference between Ca group,low-dose group and high-dose group in pathologic examination.And there was no obvious abnormality in control group.Conclusion:(1)Clinical study: Kuaiwei Tables has obvious effects on decreasing the level of Pi,improving hypocalcemia.The effects of Kuaiwei Tables were similar to Calcium Carbonate.During the treatment,there was no obvious effect on liver function,renal function and other physical and chemical indicators.Kuaiwei Tables was safe in this study.What’s more,Kuaiwei Tables could relieve symptoms,such as sour regurgitation,sicchasia and other gastrointestinal discomfort.(2)Experimental study: Niaoduqing Grains combined with medicinal charcoal or Kuaiwei Tables,whether high dose or low dose,could decrease the level of Pi,according to the present analysis sample quantity,there was no difference between them.And Niaoduqing Grains combined with Calcium Carbonate or Kuaiwei Tables could protect renal function,the difference was not obvious.They could also regulate the secretion of gastrointestinal hormone,the mechanism is unclear and waiting for further study. |
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