| Objective: To investigate the clinical efficacy of Yishen Jianpi Jiangzhuo Decoction in the protection of residual renal function in peritoneal dialysis(PD)patients with spleen and kidney yang deficiency,and to explore the possible mechanism of Yishen Jianpi Jiangzhuo Decoction in the protection of residual renal function in peritoneal dialysis patients,so as to provide theoretical and experimental support for its further clinical application.Methods: According to the inclusion criteria,select patients undergoing continuous ambulatory peritoneal dialysis treatment in our outpatient and inpatient department from January 2022 to December 2022.The peritoneal dialysis time was not less than 3 months.In addition,there are 64 cases of peritoneal dialysis patients with spleen and kidney yang deficiency,32 people in the control group and 32 people in the treatment group,according to the random number table method.The control group was treated with routine basic treatment,and the treatment group was treated with Yishen Jianpi Jiangzhuo Decoction on the basis of routine treatment of the control group for 12 weeks.The TCM syndrome scores,serum creatinine,hemoglobin,blood albumin,blood urea nitrogen,interleukin-6,serum levels of the nuclear transcription factor-κB levels,24-hour urine volume,and residual renal function were recorded before and after treatment.Meanwhile,the shedding and adverse events were recorded according to the actual situation.SPSS25.0 software was used for statistical analysis to evaluate the efficacy and safety of Yishen Jianpi Jiangzhuo Decoction.Results:(1)Before treatment,general clinical data(gender,age,course of disease),TCM syndrome score,Scr,BUN,Hb,ALB,IL-6,NF-κB,RRF,24 hours urine volume are not statistically significant and comparable(P>0.05).(2)Scr,BUN index after treatment: compared within the group,both groups were significantly improved compared with those before treatment(P<0.01);By comparison between the groups,BUN improved better in the treatment group than in the control group(P<0.05),the two groups were significantly improved compared with before treatment the improvement of BUN in the treatment group was better than that in the control group(P<0.05),but there was no statistical difference between the two Scr level groups(P>0.05).After treatment,RRF and 24 h urine volume index: compared within the group,the two groups were dramatic decline than before treatment(P<0.01);By comparison between the groups,the decrease in RRF in the treatment group was significantly smaller than that in the control group(P<0.01),and the decrease of 24 h urine volume was less than that in the control group(P<0.05).Compared with the decline rate of 24 h urine volume and RRF,the results of the treatment group were significantly lower than those of the control group(P<0.01),the differences were significant statistical significance.Hb and ALB indexes after treatment: intra-group comparison showed that both groups were extremely enhanced compared with those before treatment(P<0.01);the betterment of Hb and ALB in the treatment group was superior to that in the control group(P<0.05).NF-κB and IL-6 after treatment: Compared with pretherapy,the two groups were enormously improved(P<0.05).Treatment group of NF-κB is superior to that of the control group(P<0.05),and the ameliorate of IL-6 in the treatment group was obviously better than that in the control group(P<0.01).(3)Comparison of total points of TCM syndromes: The total points of TCM syndromes in the two groups after treatment were obviously depress than those before treatment(P<0.01).The average account of the control group after treatment was(12.04 ± 5.41),and the average score of the treatment group after treatment was(8.45±4.21).There was a statistical difference between the two groups(P<0.05).The treatment group was better than the control group.Comparison of the efficacy of TCM syndromes: The total effective rate was 86.21% in the treatment group and 60.71% in the control group,with momentous statistical difference(P<0.01).(4)Safety analysis: During the treatment of this study,all patients had stable vital signs and no adverse events.Conclusion: Yishen Jianpi Jiangzhuo Decoction can significantly improve the clinical syndromes of traditional Chinese medicine in peritoneal dialysis patients with spleen and kidney yang deficiency,reduce Scr,BUN,NF-κB and IL-6 levels,reduced the rate of RRF and 24 h urine volume and improve Hb and ALB indexes.There are no adverse reactions during the treatment and can be used safely in clinical clinic. |