首页|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
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
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维普
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,random-ized,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 end-point events,defined as eGFR increasing by more than 25% above baseline,eGFR＞75 mL/min per 1.73 m2 or 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 ana-lyzed.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 m2 in the YQPY group and 5.78 mL/min per 1.73 m2 in 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).During the intervention,2 and 4 severe adverse events were reported in the YQPY and placebo groups,respectively.Conclusion:The YQPY granules can effectively improve the renal function of patients 4 weeks after the onset of AKI,indicating that it has good efficacy for improving short-term renal outcomes in patients with AKI.The YQPY granules may be a promising therapy for adults with AKI.
Chinese herbal medicineRandomized controlled trialAcute kidney injuryRenal function
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
Department of Nephrology,Shanghai Pudong New Area Punan Hospital,Shanghai 200125,China
Department of Nephrology,Ningbo Hangzhou Bay Hospital,Ningbo 315336,Zhejiang Province,China
National Natural Science Foundation of ChinaNational Natural Science Foundation of ChinaShanghai Municipal Health CommissionShanghai Municipal Health CommissionShanghai Municipal Health CommissionShanghai Jiaotong University School of MedicineShanghai Bureau of Public Health
万方数据
维普
