Clinical Study Of Qiguiyin Granule In The Treatment Of Patients With Acute Kidney Injury With Sepsis

Objective:1.This study aims to observe the clinical effects that Qiguiyin Formula treat sepsis acute kidney injury(Sepsis AKI)and evaluate the effect of Qiguiyin Formula protect the kidney with sepsis AKI.2.In this study,it also will analyze the distribution of TCM syndromes of patients with sepsis AKI and discuss the clinical effects that Qiguiyin Formula treat with sepsis AKI with different distribution of TCM syndromes and different RIFLE criteria.Method:This experiment adopts the prospective study method,According to inclusion and exclusion criteria,patients with sepsis AKI who were hospitalized in ICU of Beijing Chinese medicine hospital and Beijing friendship hospital in February 2017-March 2018 were included.These included patients were divided into treatment group(Qiguiyin Formula group)and control group randomly.The two groups did basic treatment according to the "2016 international guidelines for management of severe sepsis and septic shock".In addition,treatment group used Qiguiyin Formula during 7 days and recorded the patients' status,examine outcome and clinical feature of before treatment,on the 3rd day and 7th day,and establish the original database analyze by SPSS.Observe the changes of each index of the two groups before and after treatment and compare the difference of the treatment days in ICU and the 28 days fatality rate.Results:1.The study included 40 patients,randomly divided into two groups,each with 20 cases.Before.the treatment,two groups of patients were not statistically different from baseline data such as the gender,age,BMI,previous diseases,infection sites,APACHE II score,SOFA score,CRRT patients,SCr,BUN,and urine volume(P>0.05),so the two groups are comparable.The 40 patients were grouped according to TCM syndromes,19 cases deficiency mixed group(47.5%),12 cases deficiency syndrome group(30%),and 9 cases sthenia syndrome group(22.5%).2.After the treatment,SCr and BUN in both groups were lower than before treatment,and the overall trend was decreasing.Compared with the two groups,SCr in the treatment group was lower than the control group at the third day and the 7th day of treatment,and on the third day of treatment it was obviously lower than the control group(P=0.049),and no significant difference was found on the 7th day of treatment(P=0.065).There was no significant difference of BUN between the two groups on the third day and the 7th day(P=0.09,P=0.6).Two groups of non-CRRT patients showed a significant increase in urine volume on the 3rd day,and the treatment group was more significantly increased(P=0.047).The patients of the two groups those need to do CRRT were compared urine volume on the third day,and the 7th day of treatment.It showed there was no significant difference(P=0.762,0.762),but the average days of blood filtration of the treatment group was obviously lower than that of the control group(P=0.043).After 7 days treatment,the recovery rate of kidney injury was higher in the treatment group than in the control group(P=0.011).3.The PCT,CRP and heart rate were all lower than before treatment.The PCT of the treatment group decreased significantly on the third day of treatment(P=0.018),but the difference of PCT in the two groups was not significant on the 7th day(P=0.231).The comparison of the CRP of these two groups showed no difference on the third day of treatment(P=0.224),which was significantly lower on the 7th day of treatment(P=0.042).After treatment,the heart rate of the treatment group was significantly slower than that of the control group(P<0.001).4.There was no significant difference of the treatment days and the 28 days fatality rate between the two groups(P=0.547,P=0.723).5.In the treatment group,deficiency mixed syndrome patients had more significantly decrease than deficiency syndrome patients and sthenia syndrome patients(P=0.001,P=0.041).However,there was no difference in the SCr,BUN and the recovery rate of kidney before and after treatment.Conclusion:On the characteristics of TCM syndromes,most of the patients with sepsis AKI are"deficiency mixed syndrome",theirin the syndrome of qi and blood deficiency mixed heat toxin is the most common.The Qiguiyin Formula can reduce the SCr level of patients with sepsis AKI,and improve the recovery rate of kidney injury.For patients with sepsis AKI that need to do the CRRT,the Qiguiyin Formula can significantly reduce the time of CRRT and get rid of the blood filtration earlier.But for non-CRRT patients,the Qiguiyin Formula can increase urine volume in 24 hours.Its possible mechanism is to protect the renal function by reducing the inflammatory response in patients with sepsis AKI and improving the microcirculation perfusion of the organs.However,if the inflammatory response is activated,the damage of multiple organs function present as "cascade reaction",and the damage of other organs are uncontrollable,and then the days of hospital stay and the 28-day fatality rate in patients with sepsis AKI were not affected by Qiguiyin Formula,which could not improve the prognosis of patients.There are different curative effects in the treatment of patients with sepsis AKI with different TCM syndromes,and the SCr effect on reduce of the deficiency mixed syndrome patients is the most significant.The differences were not obvious in patients with different stages of AKI.