Efficacy and safety of Yiqi Peiyuan granules for improving the short-term prognosis of patients with acute kidney injury:A multicenter,double-blind,placebo-controlled,randomized trial  

作　　者：Jia-jia Wu Tian-yi Zhang Ying-hui Qi Min-yan Zhu Yan Fang Chao-jun Qi Li-ou Cao Ji-fang Lu Bo-han Lu Lu-min Tang Jian-xiao Shen Shan Mou 

机构地区：[1]Department of Nephrology,Molecular Cell Lab for Kidney Disease,Shanghai Peritoneal Dialysis Research Center,Uremia Diagnosis and Treatment Center,Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine,Shanghai 200127,China [2]Department of Nephrology,Shanghai Pudong New Area Punan Hospital,Shanghai 200125,China [3]Department of Nephrology,Ningbo Hangzhou Bay Hospital,Ningbo 315336,Zhejiang Province,China

出　　处：《Journal of Integrative Medicine》2024年第3期279-285,共7页结合医学学报（英文版）

基　　金：National Natural Science Foundation of China(No.82170685,81970574);Shanghai Municipal Health Commission(No.ZXYXZ-201904,ZY[2021-2023]-0208,ZY[2021-2023]-0302);Shanghai Jiaotong University School of Medicine(No.18ZXY001);Shanghai Bureau of Public Health(No.2018JP005)。

摘　　要：Background:Yiqi Peiyuan(YQPY)prescription,a composite prescription of traditional Chinese medicine,has been used to prevent or delay the continued deterioration of renal function after acute kidney injury(AKI)in some institutions and has shown considerable efficacy.Objective:This is the first randomized controlled trial to assess efficacy and safety of YQPY for improving short-term prognosis in adult patients with AKI.Design,setting,participants and interventions:This is a prospective,double-blind,multicenter,randomized,and placebo-controlled clinical trial.A total of 144 enrolled participants were randomly allocated to two groups according to a randomization schedule.Participants,caregivers and investigators assessing the outcomes were blinded to group assignment.Patients in the YQPY group received 36 g YQPY granules twice a day for 28 days.Patients in the placebo group received a placebo in the same dose as the YQPY granules.Main outcome measures:The primary outcome was the change in the estimated glomerular filtration rate(eGFR)between baseline and after 4 and 24 weeks of treatment.The secondary outcomes were the change of serum creatinine(Scr)level between baseline and after treatment,and the incidence of endpoint events,defined as eGFR increasing by more than 25%above baseline,eGFR>75 mL/min per1.73 m2or the composite endpoint,which was defined as the sum of patients meeting either of the above criteria.Results:Data from a total of 114 patients(59 in the YQPY group and 55 in the control group)were analyzed.The mean changes in eGFR and Scr in weeks 4 and 24 had no difference between the two groups.In further subgroup analysis(22 in the YQPY group and 31 in the control group),the mean change in eGFR after treatment for 4 weeks was 27.39 mL/min per 1.73 m2in the YQPY group and 5.78 mL/min per1.73 m2in the placebo group,and the mean difference between groups was 21.61 mL/min per 1.73 m2(P<0.001).Thirteen(59.1%)patients in the YQPY group and 5(16.1%)in the placebo group reached the composite endpoints(P=0.002).Du

关 键 词：Chinese herbal medicine Randomized controlled trial Acute kidney injury Renal function 

分 类 号：R73[医药卫生—肿瘤]