| ObjectiveChronic kidney disease(CKD)is a chronic,non-communicable disease.Recognized strategies of Western Medicine for CKD are primarily symptomatic treatment due to scant evidence to demonstrate the specifics to delay CKD progression.In China context,Traditional Chinese Medicine(TCM)is frequently used in CKD regimen for its observed benefits from both clinical practice and clinical trials.From TCM perspective,the diagnosis of CKD could be varied such as consumptive disease,difficult urination or edema.Furthermore,different TCM physicians may have different insights into the mechanisms and therapeutic principle to treat CKD.These years saw growing number of physicians stating that the mechanism of CKD should be deficiency of the kidney and spleen,and thus the therapeutic principle to treat CKD in TCM should be tonifying the kidney and spleen.Results of a recent nationwide expert survey regarding TCM patterns and therapeutic principle also showed that tonifying the kidney and spleen is one of common therapeutic principle to treat CKD in TCM.In this context,derived from a famous TCM formula called SiJunzi decoction and further developed from TCM data extraction of over 10,000 CKD cases in China,Bupi Yishen Formula(BYF)was formualted by Renal Division of Guangdong Provincial Hospital of Chinese Medicine.Case series regarding use of BYF for CKD,chemical analysis on components of BYF,and relevant experimental studies have been conducted due to the desirable curative effects of BYF on CKD observed in clinical practice.However,retrospective evidence studying the effects of BYF on CKD patients is still scant.Consequently,this study aimed to evaluate the effects of BYF on non-dialysis,stage3-5 CKD patients by retrospective cohort analysis.MethodsOutpatient data were output by the Information Technology Department of Guangdong Provincial Hospital of Chinese Medicine.Data of the included CKD3-5 patients comprising demographics,laboratory findings,diagnosis and Chinese pattern differentiation,medication,and endpoint events were collected.Big Data Team of our hospital further handled the collected data,and necessary data supplement was conducted from medical information saved in the outpatient information system.Administration of specific medication was confirmed by the percentage of administration duration accounting for over 80%of the overall follow-up.Hence,the included patients were divided into BYF group and control group according to the presence or absence of BYF administration.The changes in renal function of each group from baseline to 1 year and 2 year were analyzed to evaluate effects of BYF on CKD patients.Besides,for survival analysis of incident endpoints in two groups,composite endpoints were defined as renal replacement initiation and death.Details of the composite endpoint incidence and time were recorded and further analyzed by survival analysis to evaluate the impacts of BYF on CKD patients.The ensuing Cox regression was used to explore potential factors associated with incidence of composite endpoints.ResultsIn total,2862 CKD patients with initial registered records and signed informed consent in the renal chronic disease department of Guangdong Provincial Hospital of Chinese Medicine during 2010-2018 were screened.A total of 488 non-dialysis CKD3-5 patients were eligible for final analysis,including 145 in BYF group and 343 in control group.In BYF group,the median follow-up duration of was 40(29,74)months.The median age was 58.00(49,66)years old.There were 85 male patients(58.62%).CKD3 patients accounted for 55.17%;49.66%and 15.17%patients had comorbid hypertension and diabetes respectively.In control group,the median follow-up duration of was 32(19,64)months.The median age was 58.25(47,67)years old.There were 186(54.23%)male patients.CKD3 patients accounted for 62.97%;44.02%and 16.62%patients had comorbid hypertension and diabetes respectively.For the analysis of incident endpoints in two groups,16 and 65 patients of BYF and control group respectively reached composite endpoints.In BYF group,the 1-year cumulative survival rate and 5-year cumulative survival rate were 100.00%and 88.32%respectively.In control group,the 1-year cumulative survival rate and 5-year cumulative survival rate were 99.71%、73.16%respectively.Log-rank test showed significant difference in the survival rate of between-group comparison(X2=7.66,P=0.0056).Cox regression showed that administration of BYF,age,CKD stage,baseline Urea,baseline eGFR and administration of Polysaccharide-Iron Complex were independent factors associated with incident composite endpoints(P<0.05).Moreover,all 3 adjusted models of the Cox regression documented that administration of BYF was an independent,beneficial factor associated with decreased endpoint incidence of non-dialysis CKD patients(P<0.05).ConclusionThe results indicated higher survival rate in BYF group when compared with control group.Furthermore,administration of BYF was an independent,beneficial factor for decreased risk of endpoint events,indicating its potential benefits on delaying progresion of non-dialysis CKD3-5 patients.The aforementioned results showed the potential benefits of BYF to delay the progression of CKD3-5 non-dialysis patients.Cox regression also revealed that administration of BYF,age,CKD stage,baseline Urea,baseline eGFR and administration of Polysaccharide-Iron Complex were independent factors related with incident composite endpoints.Nevertheless,this study had several limitations due to the retrospective cohort design.More studies are still needed for further exploration of effects of BYF on CKD in the future. |
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