| Objective:To study the clinical efficacy and safety of "Tongfeng Xiaotong Granules and uricqing granules" in the treatment of acute and intermittent gout.To provide safe and effective prescriptions for TCM prevention and treatment of gout and improve the level of TCM prevention and treatment of gout.Methods:In this study,65 patients with acute gouty arthritis(AGA)(dampness-heat syndrome)who met the inclusion criteria were selected from the rheumatology outpatient department of Yunnan Hospital of Traditional Chinese Medicine from November 2021 to November 2022.The patients were randomly divided into experimental group and control group.According to the treatment period of patients,patients in the acute stage of the experimental group were treated with Tongfeng Xiaotong granules first,and then treated with Uricqing granules for 8w after the disease remission entered the intermittent period.Control group was treated with colchicine tablets in the acute stage and allopurinol sustained-release capsules for 8w after the disease was relieved and entered the intermittent stage.The changes of various indexes before and after acute and intermittent sequential treatment were observed respectively,and analyzed with statistical methods to comprehensively evaluate the clinical efficacy and safety of staging sequential therapy of Tongfeng Xiaotong Granule and Uricqing granule on gout.Results:Acute stage:1 General information: A total of 65 subjects were included,including 37 cases in the experimental group and 28 cases in the control group.Patients ranged in age from 18 to 64 years.2 Scoring indicators: After treatment,the pain VAS score,doctors’ joint pain VAS score,patients’ comprehensive VAS score and TCM syndrome score of the two groups were significantly decreased compared with before treatment,with significant statistical significance(P < 0.01),and the experimental group was better than the control group in reducing TCM syndrome score(P < 0.05).3 Inflammatory indicators: After treatment,ESR and CRP levels in the two groups were significantly decreased compared with those before treatment,with statistical significance(P < 0.01),and the experimental group was better than the control group in reducing ESR level(P < 0.05).4 Disease efficacy and TCM syndrome efficacy: the total effective rate of the two groups after treatment was 75.67% in the experimental group and71.43% in the control group,with no statistical significance(P > 0.05).The total effective rate of TCM syndrome efficacy was 81.08% in experimental group and 71.43% in control group,with no statistical significance(P > 0.05).5 Safety indicators: There was no significant difference in the levels of AST,ALT,BUN and Cr between the two groups before and after treatment(P > 0.05).6 Liver injury: During the treatment,liver injury was reported in both groups,including 5 cases(13.51%)in the experimental group and 7 cases(25.00%)in the control group,with no statistical significance between the two groups(P > 0.05).The liver damage was not associated with the experimental drug,according to expert assessment.Intermittent stage:1 General information: A total of 56 patients entered the intermittent period in the acute stage,including 31 patients in the experimental group and25 patients in the control group.Finally,27 patients completed the study,including 15 patients in the experimental group and 12 patients in the control group.2 Decreased level of UA: The level of UA in the control group before treatment was lower than that after treatment,with statistical significance(P <0.05),and the decrease was more between 0w and 4w(P < 0.05).The overall level of UA in experimental groups was decreased,but the difference was not statistically significant(P > 0.05).3 UA compliance rate: After treatment,there were 3 cases(9.68%)in the experimental group and 4 cases(16.00%)in the control group.There was no statistical significance between the two groups(P > 0.05).There were 0 cases(0.00%)in the experimental group and 2 cases(16.67%)in the control group,and there was no statistically significant difference between the two groups(P > 0.05).4 Number of attacks: The number of gout acute attacks in the two groups during the observation period was compared,6 subjects in the experimental group had one attack(19.35%),and 2 subjects had two attacks(6.45%).14 subjects in the control group had one attack(56.00%),and 1 object had two attacks(4.00%).The results of gout acute attacks between the two groups showed statistically significant difference(P < 0.05).5 Indicators of glycolipid metabolism: Comparison of glucose and lipid metabolism indexes before and after treatment showed no statistical significance in TG,TC,HDL-C,LDL-C and GLU levels between the two groups(P > 0.05).6 Safety index: There were no significant differences in BUN,Cr,AST and ALT before and after treatment between the two groups(P > 0.05).7 Liver injury: Mild liver injury was reported in both groups during the treatment,including 4 cases(12.90%)in the experimental group and 3 cases(12.00%)in the control group.There was 1 case(6.67%)in the experimental group and 3 cases(25.00%)in the control group,and there was no statistical significance in liver injury between the two groups(P > 0.05).The liver damage was not associated with the experimental drug,according to expert assessment.Conclusions:The phased sequential therapy of Tongfeng Xiaotong granules and Uricqing granules can effectively improve the clinical symptoms of gout patients,reduce the level of inflammation,reduce the number of acute attacks of gout,and has certain safety and efficacy. |
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