| ObjectiveChronic kidney disease(CKD)is a common clinical chronic disease with insidious onset and difficulty in healing.It is a progressive disease that requires dialysis and other alternative treatments to maintain life when it reaches the end stage of renal disease(ESRD).It is a global public health problem to treat patients with ESRD.Compared with hemodialysis,Peritoneal Dialysis(PD)brings greater benefits in hemodynamic instability and vascular access problems,and its utilization rate increases year by year.However,intestinal dysfunction easily leads to the occurrence of repeated peritonitis and the decline of peritoneal function in PD patients.How to effectively improve the intestinal function of PD patients and reduce their complications has become an urgent clinical problem to be solved.Based on the experience of Professor Huang Chunlin,a famous doctor of Traditional Chinese Medicine(TCM),this study designed a clinical study to evaluate the clinical efficacy and safety of TiaoPiXieZhuo(TPXZ)Decoction for PD patients.Thus,through the change of intestinal flora,the target of Chinese medicine to improve the intestinal function of pd patients was explored,which provided scientific basis for the theory of ’spleen-kidney correlation,dredging qi of fu-organ and subsiding reverse’.MethodsA total of 59 patients with maintenance peritoneal dialysis who were regularly followed up in the peritoneal dialysis center of Guangdong Provincial Hospital of Traditional Chinese Medicine from December 2017 to December 2018 were included and randomly divided into two groups according to the proportion of 1:1 using the third-party random assignment.There were 29 cases.in the TCM group and 30 cases in the control group.Thirty healthy volunteers were recruited as the healthy group without intervention,and the healthy family members of pd patients were selected first.The treatment time of the two groups was 3 months.The patients in the traditional Chinese medicine group were treated with traditional Chinese medicine(TPXZ decoction).Patients in the control group were treated with active bifidobacteria(Bifico capsules).The clinical efficacy of the two groups was evaluated,and the changes in peritoneal function,peritoneal dialysis adequacy,gastrointestinal score,TCM syndrome score,lipid metabolism and safety indexes were compared.SPSS 18.0 software was used for analysis.The independent sample t test was carried out for the two sets of data conforming to the normal distribution.The rank sum test is used for measurement data that do not conform to the normal distribution.The chi-square test or Fisher’s exact probability method is used to compare the constituent ratios of classified data.The data of multiple time points(before treatment,after treatment and during follow-up)between groups were measured by repeated variance method.The fecal samples of the healthy group and the traditional Chinese medicine group before and after the intervention were processed and inspected.After passing the test,DNA extraction,PCR amplification and metagenomic sequencing were performed.To compare the microflora structure of healthy people and pd patients,and the influence of traditional Chinese medicine intervention on intestinal microflora.ResultsTPXZ decoction is effective in improving gastrointestinal symptoms,TCM syndromes,peritoneal dialysis adequacy and lipid metabolism.In terms of gastrointestinal symptoms,after 3 months of TCM intervention,the total score of gastrointestinal symptoms in the TCM group decreased by 2 points on average,showing a statistical difference(P=0.034),which relieved abdominal distension,improved appetite and softened stools.In the meantime,the total score of gastrointestinal symptoms in the control group did not change significantly before and after treatment.In terms of TCM syndromes,the total scores of TCM syndromes of PD patients in both groups were improved,and the overall symptoms of patients in the TCM group were significantly improved after treatment(P=0.004),mainly showed improvement in the symptoms of less qi and lazy speech,bitter mouth,less thirst and drinking,nerdiness,dry stools and yellow urine.In terms of peritoneal dialysis adequacy and peritoneal function,compared with the control group,the peritoneal dialysis urea clearance index(Kt/V)in the traditional Chinese medicine group after intervention showed an increasing trend and continued to the follow-up after 3 months.The peritoneal functional transport modes were mainly high average transport and low average transport,with good toxin and water clearance.In terms of lipid metabolism,compared with the control group,the low-density lipoprotein(LDL-C)level of patients in the TCM group significantly decreased after receiving TCM intervention,and the effect continued to the follow-up stage(P=0.029).No serious adverse reactions were found in the TCM group and the control group.In terms of intestinal flora,compared with healthy controls,our study found that the intestinal flora of PD patients showed significant decrease in species richness index,but no significant difference in species diversity index.This indicates that the flora distribution has changed and the balance of intestinal microecology has been destroyed.There were significant differences between the PD group and the Healthy Control group in specific bacteria and differential metabolic function,with significant statistical differences.LefSe analysis was used to select the most statistically different bacteria in PD patients,including Escherichia_coli,Bacteroides_thetaiotaomicron,Bacteroides_fragilis,Ruminococcus_gnavus,Blautia,Parabacteroides,ect,which are known as pathogenic bacteria.After the intervention of TCM,the specific intestinal bacteria of PD patients had significant changes.After the intervention,the most statistically significant specific bacteria turn to be Paraprevotella,Prevotella_copri,Fusobacterium_mortiferum,Lachnospiraceae,Veillonella_parvala,Phascolarc toba terium_succina tutens,Paraprevotella_clara,and these bacteria are common symbiotic bacterium and probiotics in healthy people.ConclusionTPXZ decoction can significantly soften the texture of stools in PD patients,appropriately increase the number of defecation,relieve the discomfort of abdominal distention and constipation,relieve uremia related symptoms,improve the abdominal environment,correct gastrointestinal dysfunction,and thereby improve peritoneal function.In addition,TPXZ decoction reduced LDL-C levels in PD patients,suggesting a possible reduction in cardiovascular risk.Compared with healthy people,the dominant specific in PD patients with intestinal bacteria are a variety of pathogenic bacteria,after the intervention of TPXZ decoction,the intestinal flora of PD patients changed,more closer to the healthy population structure of intestinal flora,suggests that TPXZ decoction on the intestinal flora of peritoneal dialysis patients have positive adjustment. |