| Objective:To observe the clinical observation of modified Guishao Liujunzi Decoction combined with roxadustat in patients with renal anemia(CKD stage 3-4)differentiated as spleen-kidney qi deficiency pattern.To explore the theoretical basis and clinical efficacy of modified Guishao Liujunzi Decoction in treating renal anemia in CKD with spleen-kidney qi deficiency.Method:This randomized,double-blind examined patients who were diagnosed with renal anaemia,CKD stage 3-4,not on dialysis and differentiated as spleen and kidney qi deficiency.Patients were included and treated at the outpatient clinic of the Department of Nephrology in The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine from September 2020 to September 2021.Patients were randomly assigned to basic treatment with roxadustat[INSTRUCTION:70mg(40-60kg)or 100mg(≥60kg)orally after meals,3 times weekly,with dose adjustment according to haemoglobin level after 4 weeks].60 patients were randomized(1:1)to modified Guishao Liujunzi Decoction(One dose daily,divided into 150mL after breakfast and dinner)as treatment group or oral Niaoduqing granules(INSTRUCTION:four times per day,one sachet at 6,12 and 18 o’clock and two sachets at 22 o’clock,also the time could be changed in ensuring that the interval is no more than 8 hours between doses)as control group and treated for 8 weeks.Respectively,at 0,4 and 8 weeks of treatment,the primary efficacy end points were examined for iron metabolism indicators(serum ferritin,serum iron,transferrin saturation),blood cell analysis(hemoglobin,red blood cell specific volume,red blood cell count,mean red blood cell volume)and renal function(Scr,BUN,GFR)and TCM evidence scoreResults:1.Red blood cell analysis.Hb,RBC and HCT in both groups had increased significantly after 4-week treatment than before(P<0.05)and continued increasing after 8-week treatment than that of 4 weeks(P<0.05).At week 8,Hb,RBC and HCT had increased significantly with treatment group versus control group(P<0.05);but the levels of MCV in both groups had no statistical difference between 4-week,8-week and prior treatment(P>0.05).There is no statistical difference between the treatment and control group after treatment(P>0.05).2.Iron metabolism indexes.SF,SI and TSAT in both groups had increased significantly after 4-week treatment than the previous(P<0.05)and continued increasing after 8-week treatment than that of 4 weeks(P<0.05).At week 8,SF,SI and TSAT had increased significantly with treatment group versus control group(P<0.05);3.Renal function indicators.Scr and BUN in both groups had decreased after 4-week treatment than before(P<0.05)and continued decreasing after 8-week treatment than the 4-week(P<0.05).At week 8,Scr and BUN decreased significantly in treatment group versus the control group(P<0.05);The eGFR level was higher in both groups at week 8(P<0.05),and the level in treatment group was higher than that of control group(P<0.05).4.Chinese medicine evidence score.At week 8,TCM evidence score in both groups was lower than prior treatment(P<0.05),and the score in the treatment group was lower than that of control group(P<0.05).5.Effective rate.(1)The total effective rate in TCM symptom score was 96.67%in treatment group and 73.33%in control group,and the clinical effect is superior to control group(P<0.05).(2)The total effective rate in renal anaemia was 76.67%in treatment group and 70.00%in control group,and the clinical effect is superior to control group(P<0.05).Conclusion:1.The combination of modified Guishao Liujunzi Decoction and roxadustat can improve the clinical symptoms of patients with renal anaemia(CKD stage 3-4).2.Modified Guishao Liujunzi Decoction combined with roxadustat can improve the levels of Hb、RBC、HCT、SF、SI、TSAT,reduce Scr and BUN,increase GFR and improve the TCM symptoms.3.Modified Guishao Liujunzi Decoction in combination with roxadustat was superior to niaoduqing Granules in combination with roxadustat in treating renal anaemia(CKD stage 3-4)of spleen and kidney qi deficiency pattern.4.Neither adverse drug events nor allergic profiles occurred during treatments. |
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