Clinical Observation Of Addition And Subtraction Of Shenling Baizhu Powder Combined With Febuxostat For Spleen Deficiency And Dampness Obstruction Syndrome Of Non-acute Gouty Arthritis

Objective:To observe the clinical efficacy and safety of Addition and Subtraction of Shenling Baizhu Powder combined with Febuxostat in the treatment of spleen deficiency and dampness obstruction syndromes in non-acute Gouty Arthritis.Methods:70 patients with spleen deficiency and dampness obstruction syndrome of non-acute gouty arthritis meeting the case selection criteria were randomly divided into observation group(35 cases)and the control group(35 cases).Both of the groups were given basic treatment,and on this foundation,the observation group was given Addition and Subtraction of Shenling Baizhu Powder plus with Febuxostat tablets orally,and the control group was given Febuxostat tablets orally.The treatment duration of both groups was 8 weeks.Recorded and collected the data of two groups before and after treatment,including Serum uric acid(SUA),total TCM syndromes scores,spleen deficiency and dampness obstruction syndromes scores,safety index(liver and kidney fuction,three routine + OB,electrocardiogram(ECG)and adverse reactions),and the frequency of acute gout attack recurrence.Statistically analysed the data with the statistical software SPSS 26.0.Results:(1)Comparison of SUA level: After treatment for 4 weeks and 8weeks,SUA level in both groups were lower than that before treatment(P<0.05).There was no significant difference in SUA level between the two groups after 4 weeks of treatment(P>0.05).While after 8 weeks of treatment,the SUA level in the observation group was significantly lower than that in the control group(P<0.05).(2)Comparison of Clinical efficacy on SUA: The total effective rate was 93.75% in the observation group and 75.00% in the control group.There was statistical difference between the two groups(P<0.05).(3)Comparison on the total TCM syndromes scores: The total score of TCM syndromes in both groups was lower than that before treatment(P<0.05).After 8 weeks of treatment,the observation group was significantly lower than the control group(P<0.05).(4)Comparison of spleen deficiency and dampness obstruction syndromes scores: The scores of 6 spleen deficiency and dampness obstruction syndromes in the two groups were lower than those before treatment(P<0.05).After 8-week-treatment,the observation group's scores on lassitude,dizziness,abdominal distension,loose stool,sore lumbus and knees were lower than that of the control group(P<0.05).While the comparison on the scores of poor appetite displayed no significant difference(P>0.05).(5)Comparison of Acute gout recurrence frequency: In the course,it appeared 3 attacks in observation group,with a total attack rate of 9.38%;6 attacks in the control group,with a total attack rate of 18.75%,and there was no statistical difference between the two groups(P>0.05).(6)Comparison on the numbers of cases with maximum dose of Febuxostat: There were 2 cases of observation group with 40 mg qd,7 cases with 60 mg qd,25 cases with 80 mg qd;0 case of control group with 40 mg qd,4 cases with 60 mg qd,28 cases with 80 mg qd.There was no statistical difference between the two groups(P>0.05).(7)Safety index comparison: In the observation group,BUN was lower than that before treatment(P<0.05),and there was no significant difference in ALT,AST and Scr compared with that before treatment(P>0.05).ALT,AST,Scr and BUN in the control group were not significantly different from those before treatment(P>0.05).There were no obvious abnormalities in ECG,kidney fuction,blood routine,urinalysis,stool+OB routine in two groups.(8)Comparison of index of side effects: During the treatment,3 patients in the observation group experienced gastrointestinal discomfort after taking the medicine,which could be relieved by themselves if not treated,with a total incidence of 9.38%.In the control group,there were 3 cases of gastrointestinal discomfort after taking the drug,and 2 cases of mild abnormal liver function,which could be restored to normal without treatment,and the total attack rate was 15.63%.There was no statistical difference between the two groups(P>0.05).Conclusions:Addition and Subtraction of Shenling Baizhu Powder combined with Febuxostat for spleen deficiency and dampness obstruction syndrome of non-acute Gouty Arthritis,compared with the treatment of Febuxostat alone,more effectively lower SUA level,reduce total TCM syndromes scores and the scores of spleen deficiency and dampness obstruction syndromes,the safety index is good,and can reduce BUN as well,the incidence of adverse reactions is similar to that of Febuxostat treatment alone.It is suggested that Addition and Subtraction of Shenling Baizhu Powder combined with Febuxostat for spleen deficiency and dampness obstruction syndromes of non-acute Gouty Arthritis is effective and safe,and Shenling Baizhu Powder is worthy of Clinical expansion application and further research.