| Objective:In this study,the clinical efficacy and safety of Qingre Zhitong decoction combined with external application of traditional Chinese medicine in the treatment of acute gouty arthritis with damp-heat accumulation were evaluated by observing the changes of efficacy indicators such as joint symptom and sign score,TCM syndrome score,serum uric acid(UA),erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),and safety indicators.Methods:In this study,70 patients who met the inclusion criteria were randomly divided into treatment group and control group with 35 cases in each group.The treatment group was treated with Qingre Zhitong decoction and external application of traditional Chinese medicine,while the control group was treated with meloxicam orally,both groups were treated for 7 days.The changes of joint symptoms and signs,TCM syndrome score,UA,ESR,CRP and safety indexes were recorded before and after treatment,and the occurrence and treatment of adverse events were recorded.The statistical software spss25.0 was used for data analysis.Results:(1)Comparison of curative effect between two groups: the effective rate was 91.4% in the treatment group and 80.0% in the control group,and there was statistical difference between the two groups(P<0.05).(2)Comparison of the scores of joint symptoms and signs(including joint pain,joint tenderness,joint swelling and joint dysfunction): the scores of joint symptoms and signs in the two groups were compared within the group after treatment,there were statistically significant differencesbetween the two groups(P<0.01);after treatment,there were statistically significant differences in the total score of joint symptoms and signs between the two groups(P<0.05),among which there was no statistical difference in the score of joint pain and joint tenderness between the two groups(P>0.05),and there was statistically significant difference in the score of joint swelling and joint dysfunction between the two groups(P<0.05).(3)Comparison of TCM syndrome score: there was statistically significant difference within the two groups after treatment(P<0.01);there was statistically significant difference between the two groups after treatment(P<0.05).(4)Comparison of laboratory indexes(UA,ESR,CRP):After treatment,ESR and CRP of the two groups were compared within the group,there was statistically significant difference(P<0.01),and there was no statistical difference between the two groups(P>0.05).After treatment,UA in the two groups was compared within the group,there was statistically significant difference in the treatment group before and after treatment(P<0.01),there was no statistical difference in the control group before and after treatment(P>0.05),there was statistically significant difference between the two groups(P<0.05).(5)Safety observation: Before and after treatment,the blood routine,urine routine,stool routine,liver function,renal function,ECG were generally normal in the two groups;in terms of adverse events,there was no adverse reaction in the treatment group and there were 1 case of mild gastric distention and 1 case of mild anorexia in the control group,and no special treatment was given.Conclusions:(1)Qingre Zhitong decoction combined with external application of traditional Chinese medicine is better than western medicine group in relieving joint symptoms,improving syndrome of damp heat accumulation and reducing uric acid level,and the two groups have the same effect in reducing inflammatory index.(2)The efficacy of Qingre Zhitong decoction combined with external application of traditional Chinese medicine is better than that of Western medicine group,with lessadverse reactions and safety,which is worthy of clinical promotion and use. |