Systematic Review And Case Investigation Of Clinical Randomized Controlled Trials In The Treatment Of Renal Anemia With Traditional Chinese Medicine

Objectives:1.Evidence-based medicine methods are used to systematically evaluate the efficacy and safety of traditional Chinese medicine in treating renal anemia,and provide evidence-based evidence for clinical research.2.To Carry out clinical case investigation and research,summarize and analyze the distribution of TCM syndromes and medication characteristics of renal anemia,summarize the pathogenesis characteristics,and provide a basis for further research on clinical treatment and efficacy evaluation of renal anemia.1.Systematic Review of Clinical Randomized Controlled Trials of Chinese Medicine in The Treatment of Renal AnemiaMethods:China Knowledge Network(CNKI),Wang Fang Data Knowledge Service Platform(Wang Fang),VIP Network(VIP),American Biomedical Journal Literature Database(Pub Med),etc.are the main retrieval sources,and the retrieval time is limited from the self-built database of each electronic database to November 2020.Collect randomized controlled trials of traditional Chinese medicine combined with western medicine to treat renal anemia,evaluate the methodological quality of the included studies,and use Cochrane Rev Man5.3 software for meta-analysis.Results:Finally,18 RCTs were included,including 1376 patients with renal anemia,including 698 cases in the observation group and 682 cases in the control group.Meta results show that treatment with traditional Chinese medicine combined with western medicine can increase the total effective rate compared with western medicine(OR=3.83,95%CI=[2.62,5.61],Z=6.91,P < 0.00001);increase hemoglobin,hematocrit,and red blood cell Count,hemoglobin(MD=12.27,95%CI=[9.3,15.23],Z=8.10,P < 0.00001);hematocrit(MD=5.31,95%CI=[3.71,6.91],Z=6.51,P <0.00001);red blood cell count(MD=0.51,95%CI=[0.41,0.62],Z=9.44,P<0.00001);lower blood creatinine,urea nitrogen,blood creatinine(MD=-56.99,95%CI=[-80.79,-33.19],Z=4.69,P < 0.00001);urea nitrogen(MD=-2.85,95%CI=[-4.06,-1.64],Z=4.63,P < 0.00001);improve iron status,serum Ferritin(MD=51.8,95%CI=[43.71,59.97],P<0.00001];transferrin saturation(MD=7.79,95%CI=[3.73,11.85],Z=3.76,P=0.0002);Reduce the incidence of adverse reactions(OR=5.61,95%CI=[0.18,0.44],P<0.00001),reduce the incidence of hypertension(OR=0.22,95%CI=[0.11,0.48],P= 0.00001).2.Investigation on The Characteristics of TCM Syndromes of Renal AnemiaMethods:This study used a retrospective investigation method to investigate the general conditions,TCM syndromes,clinical symptoms,and experiments of patients with renal anemia in the nephropathy and rheumatism department outpatient and inpatient wards from June 2019 to January 2021 in the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine.According to the CKD disease stage,153 patients were divided into three groups(CKD3,CKD4 and CKD5),and related data such as laboratory indicators.To explore the correlation between different stages of CKD and TCM syndromes in patients with renal anemia,and The correlation between various syndrome types and Hb in different stages of CKD.Results:1)A total of 153 subjects were included in this study.The age composition ratio of 153 patients with renal anemia is mainly middle-aged and elderly,and there is no statistical difference in gender and age among CKD3 group,CKD4 group and CKD5 group.The primary diseases of the subjects included diabetic nephropathy in 67 cases(43.8%),chronic glomerulonephritis in 16 cases(10.5%),hypertensive renal damage in 29 cases(17.6%),nephrotic syndrome in 13 cases(10.5%),other 11 cases(7.2%)and unknown 19 cases(12.4%).2)Among the clinical symptoms of 153 patients with renal anemia,fatigue is the most common,accounting for 88.2%,followed by soreness of the waist and knees(69.9%),anorexia(66.7%),edema(64.1%),chest tightness and shortness of breath(62.7%).The most common tongue quality was dark red tongue(24.2%),followed by dull tongue(16.3%).The tongue coating was mainly white(40.5%),followed by white greasy(22.2%)and yellow greasy(15.0%).In pulse condition,veinlets(37.3%)are the main ones,followed by deep veins(20.3%),string veins(17.0%),slippery veins(11.8%),several veins(7.8%)and astringent veins(11.8%).3)According to the general distribution rule of syndromes,qi deficiency of spleen and kidney(47.1%)is the most common the syndrome of deficiency of Ben,followed by yang deficiency of spleen and kidney(17.0%)> deficiency of both yin and yang(13.1%)> deficiency of both qi and yin(12.4%)>yin deficiency of liver and kidney(10.5%).Blood stasis syndrome(24.2%)is the most common syndrome of the excessive of Biao,followed by damp heat syndrome(16.3%)> water vapor syndrome(10.5%)> damp turbidity syndrome(9.2%)> turbid toxin syndrome(6.5%).Compared with other syndromes of excessive of Biao,blood stasis syndrome accounts for the highest proportion among qi deficiency of spleen and kidney,deficiency of both qi and yin and yang deficiency of spleen and kidney.4)The distribution law of TCM syndromes in primary diseases,in diabetic nephropathy,hypertensive renal damage,chronic glomerulonephritis,nephrotic syndrome and other primary diseases,qi deficiency of spleen and kidney and yang deficiency of spleen and kidney are most common in the deficiency syndrome of Ben.blood stasis syndrome is the most common in the excessive syndrome of Biao.According to statistical analysis,there is no difference in the distribution of primary disease between the deficiency syndrome and the abnormal syndrome(P>0.05).5)According to the distribution law of syndromes in different stages of CKD,qi deficiency of spleen and kidney is the main syndrome in CKD3 and CKD4.With the progress of the disease,yang deficiency of spleen and kidney and deficiency of yin and yang in CKD5 account for a larger proportion than the other two periods.In the the excessive Biao,blood stasis syndrome is the most common syndrome in CKD3 and CKD4,followed by damp heat,water vapor and damp turbidity.With the progress of the disease,the proportion of turbid toxin syndrome gradually increased,and turbid toxin was the most common in CKD5 stage.Comparing the the deficiency Ben and the excessive Biao between the groups,it was found that CKD3 and CKD4 were not different,but CKD3 and CKD5,CKD4 and CKD5 were different,P< 0.05.6)In terms of Hb level,the Hb level of each syndrome gradually decreased with the deterioration of renal function.In each stage of CKD3～5,the Hb level of qi deficiency of spleen and kidney> yang deficiency of spleen and kidney > deficiency of both qi and yin > yin deficiency of liver and kidney> deficiency of both yin and yang syndrome.In the CKD 3 and 4 groups,the Hb level of the deficiency syndrome is statistically different P<0.05;in the CKD5 stage group,no statistical difference P>0.05.In the syndrome of excessive Biao,the Hb level of blood stasis syndrome>damp heat> damp turbidity> moisture> turbid toxin syndrome,there was no statistical difference between the standard evidence of CKD 3～5 group(P> 0.05).Comparing the deficiency Ben and the excessive Biao between the groups,it was found that there were statistical differences among the three groups in the syndrome of yin deficiency of liver and kidney and blood stasis(P<0.05).3.Data Mining Research on The Prescriptions of Renal AnemiaMethods:Collect Chinese medicine prescriptions with prescription data in the second part of cases,enter the standardized prescriptions into Excel 2010 to establish a database,and make frequency statistics on drug use frequency and meridian tropism.SPSS Modeler 18.0 software is used to analyze drug association rules by Apriori algorithm,and SPSS 26.0 software is used to make systematic cluster analysis on high-frequency drugs.Results:Through the analysis of 137 prescriptions,the results showed that among the 248 traditional Chinese medicines,sweet taste was the highest,accounting for 31.9%,followed by bitter taste 30.9% and pungent taste 19.6%.The distribution of drugs is mainly cold,warm and flat,among which cold drugs account for 36.9% and warm drugs account for 35.2%.The main meridians are liver,spleen,stomach,lung and kidney,followed by heart,large intestine and bladder,ect.23 high-frequency drugs are obtained,and astragalus and rhubarb charcoal are mined through association rules,Astragalus,Rhubarb Charcoal,Puhuang Charcoal,Codonopsis,Salvia Miltiorrhiza,Bran Fried Atractylodes,Bran Fried Atractylodes,Poria,Fenugreek,Alisma,Polyporus,Centella Asiatica,Angelica,Eucommia,Puhuang Charcoal,Safflower,Polyporus,Qing Pinellia,Eucommia,Polygonum multiflorum,Licorice 21 core medicines,as well as "Astragalus-rhubarb charcoal","Astragalus-Poria","Rhubarb charcoal-rhubarb","Astragalus-rhubarb",etc.96 Group the core drug pairs,and obtain 5 new combinations through cluster analysis.Conclusions:1.The results of the systematic review show that traditional Chinese medicine is effective in treating renal anemia,and its safety is relatively high.2.The location of renal anemia is mainly in spleen and kidney,and it also involves heart,liver,lung and other viscera,which are mostly based on the syndrome of deficiency Ben and excessive Biao.3.The distribution of renal anemia syndromes are mainly qi deficiency of spleen and kidney,which runs through the beginning and end of the disease.There are different degrees of dampness,heat,blood stasis,turbidity and other pathological factors,mainly with blood stasis syndrome,and each has its own focus due to the different stages of CKD.4.The distribution of TCM syndromes of renal anemia has nothing to do with the original disease.5.The degree of renal anemia is positively correlated with the deterioration of renal function,and changes dynamically with the changes of TCM syndromes of renal anemia.6.The changing trend of TCM syndromes of renal anemia has a certain law to follow,roughly from qi/yang deficiency of spleen and kidney to deficiency to qi and yin/yin deficiency of liver and kidney,and eventually develops to deficiency of both yin and yang.7.The core prescriptions and new prescriptions obtained by the research closely follow the pathogenesis of " qi deficiency of spleen and kidney",grasp the concurrent syndromes,and provide reference for clinical treatment of renal anemia.