| Objective:To discuss the Curative effect and security of Yishen Huayu Decoction in combination with empagliflozin in the treatment of Diabetic kidney disease stage 3-4,focusing on the benefits and drawbacks of Yishen Huayu Decoction and empagliflozin in improving patients’ clinical symptoms,proteinuria and other related clinical indicators,as to provide a certain basis for promoting the treatment of DKD with integrated TCM and western medicine,explore a new scheme for the treatment of DKD with integrated TCM and western medicine,and improve the efficacy of Diabetic kidney disease in clinical work.Methods:The methodology of this study was randomized,single-blind,and controlled.The 96 patients collected in this study were from the inpatient and outpatient departments of the Jiangxi Provincial Hospital of Traditional Chinese Medicine’s nephrology department.All included patients met the criteria and were randomly divided into 3 groups of 32 patients each.The control group received classic basic western medicine,whereas the empagliflozin group received empagliflozin on a par with the control group.The integrated TCM and western medicine group received Yishen Huayu Decoction on a par with the empagliflozin group,with a test cycle of 12 weeks.Statistical methods were used to compare the TCM syndrome scores,relevant laboratory indicators,and clinical efficacy of the three groups,and the safety of the trial was observed throughout.Results:There were no noteworthy differences in age,gender,disease duration,various biochemical parameters and symptom scores before treatment among the 3 groups(P>0.05),suggesting that comparability of the three groups.1.Efficacy of TCM syndromes: Effective rate was 46.9%in the control group,62.5% in the empagliflozin group,and 100% in the integrated TCM and western medicine treatment group.There was distinguished statistical difference in the effective rate among the 3groups(P < 0.001).Compared with the empagliflozin group and the control group,there was no distinguished difference(P>0.05),but there was distinguished statistical difference between the integrated TCM and western medicine treatment group and the western medicine group or the control group(P<0.05).2.Main symptoms:After treatment,there was no distinguished discrepancy among the three groups(P>0.05).There were distinguished differences in the empagliflozin group and the integrated TCM and western medicine treatment group before and after treatment(P<0.05).Qi short sloth speech on the control group before and after treatment group had no distinguished difference(P > 0.05),and there were distinguished difference in the scores of other main symptoms in the control group(P<0.05).It showed that all three groups had a significant effect in improving major symptoms,but the control group did not show improvement in improving shortness of breath and slothful speech.3.In terms of improvement of secondary symptoms:there was a statistical difference in the symptom scores of thirsty and drinking,insomnia and forgetfulness among the 3 groups posttreatment(P<0.05).There were major differences here between TCM & western medicine treatment group as well as the control group among them(P<0.05),but neither among the TCM &western medicine treatment group and the empagliflozin group or between the empagliflozin group and the control group(P>0.05).The findings of the three groups’ intra-group analyses before and after dramatically demonstrated that the levels of secondary symptoms were statistically significant(P<0.05).Secondary symptoms were improved in all three groups,especially in thirsty and drinking,insomnia and forgetfulness,the treatment group of TCM and western medicine was better than the control group,the treatment group of TCM and western medicine and empagliflozin group,empagliflozin group and the control group showed no advantage between.4.In terms of third symptoms:For the violet and blue lips,the treatment group using traditional Chinese and western medicine clearly outperforms the control group or the empagliflozin group(P<0.05);The TCM plus western medicine treatment group outperformed the empagliflozin group in terms of ecchymosis(P<0.05).However,the western medicine group and the control group did not reflect the strengths and weaknesses.In the other concurrent syndromes,the three groups showed no difference(P>0.05).5.Therapeutic effectiveness: The effectiveness rate was 59.4% in the control group,71.9 % in the empagliflozin group,and93.8% in the group receiving both TCM and western medicine as treatment.There was a statistically meaningful variation in the total effective rate seen between three groups(P≤0.001).Among them,the TCM and western medicine treatment group measured differently from the control group(P<0.05).There was no discernible difference between the empagliflozin group and the control group or the TCM and western medicine treatment group(P>0.05).6.After treatment,there was no discernible change between the three groups’ fasting blood sugar,2-hour postprandial blood sugar,or glycosylated hemoglobin levels(P>0.05).However,there were significant differences within the groups before and after treatment(P<0.001).This indicates that the FPG,P2 PG and Hb A1 c of the three groups decreased after treatment,but it does not explain the advantages of the three groups in terms of glucose control.7.There were no significant differences in Scr,BUN and UA between and within the three groups before and after treatment.The results showed that the three groups had no significant effect on reducing Scr,BUN and UA,and there was no difference among the three groups.It is not possible to explain the effect of the Empagliflozin and Yishen Huayu formulae in reducing Scr,BUN and UA.8.No adverse events were reported in all patients in this trial,indicating a high level of safety for Yishen Huayu Decoction and empagliflozin.Conclusion:The effect of Yishen Huayu Decoction in combination with empagliflozin in the treatment of DKD stage 3-4 kidney deficiency and blood stasis is superior than that of conventional western medicine or simply addition of Empagliflozin.In particular,it showed significant advantages in improving clinical symptoms,TCM syndrome score and 24 h UTP reduction.The combination of Yishen Huayu Decoction and Empagliflozin may protect renal function,primarily by reducing proteinuria.There were no adverse reactions in the study,which suggests that Yishen Huayu Decoction and empagliflozin are safe.The combination of Yishen Huayu Decoction and empagliflozin is effective and safe and deserves further clinical study. |