Syndrome Elements' Characteristics Of Contrast-induced Nephropathy After Emergency Percutaneous Coronary Intervention And Efficacy Evaluation Of Bazhen Decoction

BackgroundPercutaneous Coronary Intervention(PCI)is the main and modern treatment for the coronary heart disease,especially for the acute myocardial infarction.Contrast-Induced Nephropathy(CIN)is a post-intervention complication due to contrast agent.There is no clear and effective therapeutic drugs.CIN often occurs with other critical illnesses and poor prognosis.Mortality during hositalization and cardiovascular adverse events were increased.It has become clinically as medical care problem and research hotspot.The prevention and treatment of CIN with traditional Chinese medicines is still in the initial stage,clinical and animal experimental studies of traditional Chinese Medicines(TCM)and traditional Chinese patent medicines have been proposed and have achieved the preliminary results.China is a big country with cardiovascular diseases.With aging population and increase in the population of contrast agent risk factors,the incidence of CIN is increasing year by year.Traditional Chinese medicines can exert the virtue of differentiation and individualized treatment,as adjunctive therapy of conventional medical treatment in the CIN patients,and could improve the overall prevention and treatment of CIN.Objective1.A total of 602 patients undergoing emergency PCI and 153 patients with contrast-induced nephropathy were included in the study.With the summary analysis of TCM syndromes and syndrome elements,cross-sectional epidemiological investigations were conducted in order to find out the pathogenesis characteristics,clinical manifestations,disease progression and prognosis of contrast-induced nephropathy.Diagnostic evidence was summarized from the perspective of traditional Chinese medicine.To discuss and summarize the distribution of disease and disease characteristics of CIN,and provide reference basis for clinical TCM treatment based on syndrome differentiation and treatment.2.According to the conclusions of Part ?,with the thought of application of qi and phlegm supplementation to reconcile qi and blood,to protect the spleen and stomach to achieve the righteousness and exorcism,based on the internal standard treatment plus Bazhen Decotion to treat the CIN patients.Through a randomized,controlled,small-sample clinical trial of 70 cases of patients with CIN after emergency coronary intervention,to evaluate the efficacy of internal standard treatment combined with Bazhen Decoction on the improvement of contrast-induced renal damage,and provide a reference for clinical treatment of CIN patients.Part ? Syndrome Elements' Distribution of CIN after emergency PCIMethods1.Case selectionFrom January 1,2016 to June 30,2017,a total of 602 inpatients diagnosed with coronary heart disease and coronary artery interventional treatment were selected,in the cardiac intervention center of emergency department of Wangjing Hospital,China Academy of Chinese Medical Sciences.2.Diagnostic criteriaa)Coronary heart disease diagnostic criteriaWestern diagnostic criteria include unstable angina pectoris(UA),stable angina pectoris(SA),ST-elevation myocardial infarction(STEMI),and non-ST elevation No-ST-elevation myocardial infarction(NSTEMI)refers to the guidelines and diagnostic criteria of the Cardiovascular Branch of the Chinese Medical Association.b)Diagnostic criteria for CINReference the latest diagnostic criteria Results:Published by the European Society of Urogenital Radiology(ESUR)Contrast Medium Safety Committee in 2012.CIN is difined as the impairment of renal function-measured as either a 25%increase in serum creatinine(SCr)from baseline or a 0.5mg/dL(increased 44.2?mol/L,Note:SCr unit:mg/dL=88.4?mol/L)increase in absolute SCr value within 2-3days after intravenous contast administration,and ruled out other factors of impairment of renal function.3.Risk assessment of CINMehran Risk Score(MRS).4.Statistical analysis methodsThis study selected Epidata 3.1 software,according to the designed case report form(CRF was reviewed by expert)to establish the database to entry the data.Collect basic clinical information during hospitalization and surgery.Collect information of four Chinese medical examinations and fill out the clinical information collection form of Chinese medicine.Syndrome classification criteria:According to Zhu Wenfeng's Study of Syndrome Elements Differentiation,the constituent elements of each syndrome are composed of two basic units:virulence and pathogenicity.SPSS 23.0 statistical software was used for the statistical analysis.Hypothesis test was performed on two-sided test(test level:?=0.05).When p<0.05,the statistical difference was considered.When p<0.01,the significant statistical difference was considered.Descriptive statistics:Measurement data is described by mean and standard deviation.Mean ± standard deviation is used for the normally distributed data,and median and quartile intervals are used for non-normal distribution data.Count data is described by frequency,number of cases or percentage,composition ratio(%).Differential statistics:measurement data hypothesis test uses independent sample t-test for samples that are normally distributed data,Wilcoxon test is used for non-normal distributions data;chi-square test is used for hypotheses of count data,and is based on sample size and four cells.The table requires the decision to apply standard chi-square or exact test(Fisher test).Correlation analysis:Spearman correlation analysis was used for the unordered variable data,and rank sum test(Wilcoxon test)is used for the rank variable data.Multivariate regression analysis used Logistic linear regression.Results1.SummaryA total of 602 coronary heart disease undergoing emergency PCI patient were included in the study,including 421(69.93%)male and 181(30.07%)female.The maximum age of the patients was 96 years old and minimum age was 28 years old,with an average of 63.55±12.73 years old.The maximum body mass index(BMI)of the patient was 34.60 Kg/m2,and the minimum was 15.78 Kg/m2,with an average of 25.38±3.10Kg/m2.2.Medical HistoryHypertension:214 cases(35.55%),type 2 diabetes:261 cases(43.36%),dyslipidemia:155 cases(25.75%),cerebrovascular disease:111 cases(18.44%),previous myocardial infarction:126 cases(20.93)%),arrhythmia:92 cases(15.28%),chronic renal insufficiency:65 cases(10.80%),anemia:39 cases(6.48%).3.Univariate regression analysis showed differences in age,serum creatinine,glomerular filtration rate,endogenous creatinine clearance,?2 microglobulin,neutrophil/lymphocyte ratio,hematocrit,type 2 diabetes,chronic renal insufficiency,anemia,and previous myocardial infarction.The above-mentioned relevant factors were included in the multivariate regression analysis(test level a=0.05,95%CI)and showed serum creatinine,neutrophil/lymphocyte ratio,chronic renal insufficiency,anemia,etc.were significant statistical difference.4.Diagnosis of TCM Syndromes in CIN patient with Emergency PCIContrast-induced nephropathy(CIN)occurred in 153 of 602 patients undergoing emergency PCI.The TCM syndrome differentiation types of CIN population were as follows:4 cases(2.61%)with blood stasis syndrome,76 cases(49.67%)with qi deficiency and blood stasis syndrome,14 cases(9.15%)with phlegm and heart arrest syndrome,and 2 cases with qi stagnation and blood stasis syndrome(1.31%),38 cases(24.84%)of Qi and Yin deficiency,6 cases(3.92%)of heart-kidney yin deficiency syndrome,11 cases(7.19%)of yang deficiency syndrome,and 1 case(0.65%)of chilly stagnation syndrome.5.Syndrome Elements' distributionThe symptoms and signs of 153 patients(CIN)were collected.The information of four consultations was collected.According to the dialectical findings,the patients with CIN were predominantly affected by Spleen,Lung,Stomach,Heart and Kidney.The frequency was more than 50%,and the frequency was listed from high to low).Among them,there were 6 patients with single syndrome element,11 patients with 2 syndrome elements,and 126 with 3 or more.Among the patients,there were 10 cases that failed to effectively judge the syndrome elements.After extraction,the preoperative syndrome elements of CIN were mainly qi deficiency,blood stasis,qi stagnation,wetness,yin deficiency,and cramps.In addition to blood deficiency,there were 1 patient with 4 virulence factors,1 patient with 5 virulence factors,and 151 patients with 6 or more syndrome elements.There was no effective judgment of patients with virulence.ResultsThe incidence of CIN after emergency PCI is higher than normal cases,and more attention should be paid to it.The ratio of NLR correlates with the onset of CIN.CIN may be an independent disease.In the early stage of contrast-induced nephropathy,Qi deficiency and blood stasis accounted for the majority,and the disease location was mainly in the spleen.The treatment of CIN needs to be as early as possible,in order to cut off the virtual deficiency of evil spirits.Part ? Efficacy Evalatuation of Bazhen Decoction for CIN patientsMethods1.Case selectionA total of 70 patients with CIN after Emergency Percutaneous Coronary Intervention in the cardiac intervention center of emergency department' of Wangjing Hospital,China Academy of Chinese Medical Sciences during July 1,2017 to January 10,2018.2.Diagnostic criteriaSee Part ?.3.Statistical analysis methodsSee Part ?.Patients with CIN after emergency PCI were randomized.Contrast-induced nephropathy patients who met the inclusion criteria were enrolled using a randomization list to consider the incidence of CIN and the rejection and shedding factors during the observation process.A total of 70 patients were included in the study,35 in the control group and 35 in the test group.The changes of serum creatinine,blood urea nitrogen,and glomerular filtration rate before and after treatment were evaluated in both groups,as well as the improvement of symptoms after treatment with traditional Chinese medicine.Experimental group:internal standard treatment + Bazhen Decoction,governing method name:qi nourishing blood stasis method.Prescription name:Bazhen Decoction(addition and subtraction with the individual situation)Rehmannia glutinosa 15g,Angelica 15g,Angelica 10g,Chuanxiong 12g,ginseng 10g,Zhigancao 10g,Atractylodes Rhizome 15g,Poria 15g.Dosage:1 daily,water blunt,once in the morning and evening,7 days in a row.Drug Source:Wangjing Hospital Traditional Chinese Medicine Fry Granules Pharmacy.Control group:Internal standard treatment.ResultsClinical efficacy evaluationPaired t-test and covariance analysis were performed using SPSS 23.0 software.test group and control group were analyzed before and after administration and between groups.Combined data suggested that the test group was more conducive to the recovery of serum creatinine and urea nitrogen levels to normal level.By analysis of covariance,the serum creatinine level in the control group was 10.693 ?mol/L higher than that in the test group(95%Cl:6.678?14.708,P<0.001).It can be considered that adding Bazhen Decoction can help reduce the serum creatinine level.The level of urea nitrogen in the control group was 0.450 mmol/L higher than that in the test group(95%CI:0.089 to 0.811,P=0.015<0.05),suggesting that the use of Bazhen Decoction can help reduce the level of urea nitrogen.At the same time,the level of serum ?2 microglobulin in the control group was 0.471 mmol/L higher than that in the test group(95%CI:0.289-0.654,P<0.001),suggesting that the addition of Bazhen Decoction can help lower the level of serum ?2 microglobulin.The overall results showed that the protective effect of Bazhen Decoction on kidney damage was more significant than that of the control group.Bazhen Decoction may improve kidney damage through anti-oxidative stress.The levels of superoxide dismutase in the two groups were statistically significant after treatment(P<0.05).The Mann-Whitney U test was used.The mean value of superoxide enzymes in the experimental group was 140.826 U/mL after treatment.It was 141.70 U/mL;the average value of the control group was 131.573 U/mL,and the median was 133.500 U/mL.The difference in efficacy between the two groups was statistically significant(Z=-3.013,P=0.003).The standard treatment of Tang combined with internal medicine is more conducive to the improvement of SOD level.The TCM syndrome scores of the experimental group and the control group were compared after the treatment.In the same group,the Mann-Whitney U test was used:Z=4.559,P=0.001(p<0.01),suggesting significant differences.After the treatment with traditional Chinese medicine,symptoms such as chest tightness,fatigue,and poor appetite improved significantly.ConclusionsOn the basis of previous evidence of syndromes,the pathogenic syndromes are qi deficiency and blood stasis,and the disease location is mainly in the spleen.Bazhen Decoction and Qixue are used to replenish qi and phlegm and protect the spleen and stomach.Tests have shown that the effect of Bazhen Decoction on kidney damage in patients with CIN may improve renal damage through antioxidative stress.From the typhoid fever theory can not be said,can not sweat law,the incidence of contrast agent nephropathy in the treatment of people can not be exorcism too much,combined with drug poisoning method,the need for contrast agent kidney disease in the early stage of righting and exorcism treatment.Prospects methods can be used as a method to treat early contrast nephropathy.On the basis of previous evidence of syndrome elements',the virulence factors are qi deficiency and blood stasis.The disease location is mainly in the spleen.Bazhen Decoction is used to replenish qi and phlegm,reconcile qi and blood,and take care of the spleen and stomach to correct the sputum.Tests have shown that adding Bazhen Decoction combined with internal standard therapy can improve kidney damage in patients with contrast-induced nephropathy,possibly through anti-oxidative stress.In addition,compared with the control group,the patient's symptoms of discomfort improved significantly.From the treatise on febrile diseases can not diarrhea,can not sweat,the incidence of CIN treatment can not be exorcism too much,combined with traditional Chinese medicine antidote poisoning method,Concluded as follow:the need for early treatment of CIN righting and exorcism treatment,and prospects the mediation method as the treatment of early with traditional Chinese medicine.