| ObjectiveRespiratory tract infection(RTI)is one of the risk factors for progressive loss of kidney function.Lifestyle management has shown potential effect to prevent RTI in chronic kidney disease(CKD)patients.The study was to assess the efficacy and safety of lifestyle management in reducing RTI of CKD patients.MethodsIn this prospective randomized controlled trial(RCT),patients with CKD diagnosed with RTI for more than twice within one year were enrolled between September 1st,2017 to March 31st,2019.Then patients were randomly assigned at a ratio of 1:1 to lifestyle management group with life behavior education,acupoints massage and dietary guidance or control group with conventional care Both groups received conventional care according to guideline recommendations.The primary outcome was the interval of first occurrence of RTI.Secondary outcomes mainly included the change of PCR,change of eGFR,immunity indices,cardiovascular events,liver and kidney function.Independent-samples T test and rank-sum test were used to the analyze data with SPSS18.0.This study was registered with Chinese Clinical Trials Registry,ChiCTR-IOR-17012654.Results1.540 patients with CKD were screened in this trial.Among them,232 were randomly assigned into two groups,116 to the lifestyle management group and 116 to the control group.The average follow-up time was 11.04±3.16 months,with an average age of the two groups were 51.65±12.97 and 56.20±14.02 respectively(P=0.005).The average RT1 frequency in the past one year in the two groups was 3.89 times and 3.57 times,respectively(P=0.537),and average duration was 7.22±8.52 days and 6.56±5.23 days,respectively(P=0.576).There was no statistical difference between the two groups in gender,primary disease,comorbidity,liver and kidney function,blood lipid,urinary protein and other immune parameters.2.Primary outcome:The interval time to the first occurrence of RTI in the lifestyle management group was 85.65±84.97 days,compared with 84.36±90.63 days in the control group,but there was no statistical difference(P>0.05).The results of survival analysis showed that the average survival time of the first RTI in the lifestyle management group was longer than that of the control group(68 days vs 65 days)for those patients whose RTI>4 times in the previous year,and the risk of RTI was reduced(HR=0.87,95%CI[0.77-1.31],P=0.021).3.Secondary outcomes:During the follow-up,RTI occurred less frequently in the lifestyle management group than in the control group(2.56±0.36 vs.2.74±0.38,P=0.737)and for a shorter duration(3.83±0.58 vs.4.39±0.60,P=0.513).The PCR of the lifestyle management group was lower than that of the control group(MR=-0.05,95%CI[-0.28-0.19],P=0.706),while the eGFR was higher(MR=8.18,95%CI[-4.12-20.5],P=0.191).The levels of IgA,C4,CH50,CD3CD4 and CD3CD4/CD3CD8 were relatively higher in the lifestyle management group,while the levels of CD8 were relatively lower.The differences were more obvious in the patients with high-frequency RTI(RTI>4)in the previous year.There was no significant difference between the two groups in liver and kidney function,blood lipid,electrolyte and other safety indicators.ConclusionsLifestyle management shows the effect to reduce the prevalence of RTI in CKD and decrease proteinuria.There was no significant difference in the change of immunity indices between two groups.No cardiovascular events or deaths occurred in this trial,neither severe adverse events.There was no significant difference in safety parameters between two groups. |
PDF Full Text Request