| Aim:ystematic evaluate the clinical efficacy and safety of YiQiBuShen recipe in the treatment of diabetic nephropathy.And to observe the efficacy and safety of TANGSHEN decoction in the treatment of early diabetic nephropathy(stage Ⅲ).Explore the correlation between TCM syndromes and frailty in elderly diabetic nephropathy patients.Method:this study includes three parts.1.Systematic evaluation and meta-analysis of the treatment of early diabetic nephropathy with YIQIBUSHEN recipe.The main method is to use computer retrieval from databases such as China biology medicine disc(CBM disc),Chinese national knowledge infrastructure(CNKI),Wan Fang medical data base,Wei Pu database,PubMed,Cochrane Library,EM base,and so on,while the searching time is from the start of the database to Oct.28,2018.And relative literature,in the past two years,from World Chinese Journal of Diabetes,Chinese Journal of Integrated traditional and Western medicine on kidney,China Journal of Traditional Chinese medicine and pharmacy,Journal of traditional Chinese medicine,Chinese Journal of integrated Traditional and Western medicine have been manually retrieve.The clinical randomized controlled trials(RCT)on the treatment of diabetic nephropathy by using YiQiBuShen recipe have been selected.The data were extracted and the quality of literature were evaluated according to the standard of Cochrane Handbook 5.1 And Rev Man 5.3 software was used to meta analyze the extracted data.2.Clinical efficacy of TANGSHEN decoction in the treatment of early diabetic nephropathy(stage III).Open,random control design method was adopted.The sample size of each group was 21 cases,with a total of 42 cases.The included cases were from the outpatient and inpatient patients with early diabetic nephropathy(stage Ⅲ)in our hospital,and they signed the informed consent.The 42 patients were divided into treatment group and contrast group according to their willingness,with 21 patients in each group.The patients in the treatment group were treated with traditional western medicine by oral administration of TANGSHEN decoction.The TANGSHEN decoction was a Chinese medicine granule for decoction with 200ml of water.The contrast group received conventional western medicine treatment.The test period is 6 months.Observation point:treatment group at 0 months,3 months,6 months,a total of 3 times,the contrast group at 0 months,6 months,a total of 2 times;Efficacy index:the treatment group was evaluated before treatment,3 months and 6 months after treatment,and the contrast group was evaluated before treatment and 6 months after treatment.Safety indicators:once at 0 month,once at 6 months,and should be checked within 1 week before and 1 week after drug withdrawal,and the occurrence of adverse reactions should be closely observed and recorded.Efficacy evaluation was conducted,including ACR,HbAlc,GFR,FBG and other related clinical indicators,TCM symptom score scale,and quality of life scale of diabetic patients DSQL.To evaluate the clinical safety of drugs.3.Explore the correlation between TCM syndromes and frailty in elderly diabetic nephropathy patients.According to TCM clinical diagnosis and treatment terms·syndrome part syndrome judgment standard and pathological viscera diagnosis standard,at the same time,The frailty index of the aged patients was evaluated by the frailty scale of integrated traditional Chinese and western medicine,and the frailty grade of the patients was calculated according to the clinical frailty scale,Pearson correlation analysis,spiel man analysis,independent sample T test and chi-square test were used to compare the relationship between different syndromes and frailty index and frailty grade.Results:1.Systematic evaluation and meta-analysis of the treatment of early diabetic nephropathy with YIQIBUSHEN recipe.A total of 12 studies were included.The quality of the study included is generally low.Meta-analysis results showed that,Compared with the combined use,single supplemental YiQiBuShen prescription reduced urinary protein[RR=-0.74,95%CI=(-0.89,-0.59)]and reduction of Hbalc[RR=-0.28,95%Cl=(-0.58,0.01))and fasting blood glucose[RR=-0.56;95%CI=(-0.77,-0.36)]is more advantageous.2.Clinical efficacy of TANGSHEN decoction in the treatment of early diabetic nephropathy(stage III).2.1 Comparison between groupsMain efficacy indicators:after the 6-month treatment,the ACR index of the treatment group was significantly lower than that of the contrast group,with a significant difference(P<0.05),and there was no statistical difference in HbAlc compared with the control group(P>0.05).After 6 months of intervention,the improvement rate of ACR and HbAlc in the two groups and the total effective rate in the treatment group were higher than that in the contrast group,and there was a significant difference between the two groups(P<0.05).Secondary efficacy index:compared with the contrast group,there was no statistical difference in FBG and GFR(P>0.05).In diabetes patients quality of life scale,6 months after the intervention,the treatment group in the treatment of dimensions,score lower than the contrast group,there is significant difference(P<0.05).in physiological function,psychological function,social relations of three dimension and total score compared with the contrast group,there was no statistically significant difference(P>0.05).In the TCM symptom score scale,there was no statistically significant difference in the TCM symptom score between the treatment group and the contrast group after the 6-month intervention(P>0.05).The improvement rate of TCM symptoms in the treatment group and the contrast group was not significant,and there was no statistical difference between the two groups(P>0.05).2.2 Comparison in the groupMain efficacy indicators:the treatment group was treated for 3 months,and there was no statistically significant difference in ACR before and after intervention(P>0.05).after 6 months of intervention ACR was higher than that before treatment,and the difference was statistically significant(P<0.05).The HbAlc of the treatment group after 3 months of intervention was lower than that before treatment,and the difference was statistically significant(P<0.05).After 6 months of intervention,HbAlc decreased compared with that before treatment,with no statistically significant difference(P>0.05).There was no significant difference between 3 months after intervention and 6 months after intervention(P>0.05).According to the change trend of HbAlc measured value,it can be observed that the effect of TANGSHEN decoction on reducing HbAlc is better at 3 months than 6 months.The improvement rate of ACR and HbAlc in the treatment group and the total effective rate at 3 months were higher than that at 6 months.There was no statistical difference between the two treatment periods(P>0.05).Secondary efficacy indicators:FBG in the treatment group after 3 months of intervention was lower than that before treatment,and the difference was statistically significant(P<0.05).FBG after 6 months of intervention was also lower than that before treatment,the difference was statistically significant(P<0.05).There was no significant difference between 3 months after intervention and 6 months after intervention(P>0.05).According to the change trend of measured FBG,it can be observed that the effect of TANGSHEN decoction on reducing FBG is obvious,and it is better than 6 months at 3 months.The GFR of the treatment group increased after 3 months and 6 months of intervention,and the difference was not statistically significant(P>0.05).In terms of TCM symptom score,the TCM symptom score of the treatment group showed a downward trend at 3 months,and there was no statistically significant difference in the TCM symptom score before and after intervention at 3 months and 6 months(P>0.05).The TCM symptom scores of the contrast group were higher after 6 months of intervention than before intervention,and there was a significant difference(P<0.05).3.Explore the correlation between TCM syndromes and frailty in elderly diabetic nephropathy patients.According to the observation of 44 patients in this study,with the increase of age,the frailty index and frailty grade gradually increased in the elderly patients with diabetic nephropathy,the frailty index and frailty grade were positively correlated,and the frailty index was positively correlated with age.The more syndromes there were,the higher the frailty index and frailty level were.The longer the course,the higher the frailty index and frailty level.The more complications,the higher the frailty index and frailty grade.The longer the course,the more complications.The most common syndromes of 44 elderly diabetic nephropathy patients were Qi deficiency and Yin deficiency.In the elderly patients with diabetic nephropathy,the longer the course of the disease was,the higher the frailty level was.The more complications,the higher the frailty index and frailty grade.The longer the course,the mote complications;The course of the disease was independent of the frailty index.There was no significant correlation between chronic kidney disease stage and age,disease course,syndrome differentiation,complications,frailty grade and FI index in elderly patients with diabetic nephropathy.The frailty index of elderly patients with diabetic nephropathy was different under the syndromes of Yang deficiency,phlegm turbidity and blood stasis,and there was no difference under the syndromes of qi deficiency,blood deficiency,Yin deficiency,Qi stagnation,dampness,heat and toxicity.Phlegm turbidity and blood stasis in each syndrome were correlated With frailty classification,but there was no significant correlation between Qi deficiency,blood deficiency,Yin deficiency,Yang deficiency,Qi stagnation,heat,dampness,toxicity and frailty classification.Conclusion:1.YiQiBuShen recipe can improve the clinical effi ciency of early diabetic nephropathy patients,reduce proteinuria,reduce the level of glycosylated hemoglobin,and has good clinical safety.2.TANGSHEN decoction treatment of early diabetic nephropathy(phase III)can effectively improve the patients’ renal function,regulate glucose metabolism,and delay the progress of the disease of patients with early diabetic nephropathy,at the same time during the period of clinical observation found no serious adverse reactions related to prove that TANGSHEN decoction good safety and low risk,can be used as one of the prevention and treatment of early diabetic nephropathy,worthy of clinical application.3.Some TCM syndromes of elderly patients with diabetic nephropathy are closely related to the degree of frailty. |
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