| Objective:To explore the clinical efficacy and drug safety of Tongfengning combined with Diclofenac Sodium Enteric-coated Tablets in the treatment of damp and hot accumulate knot acute gouty arthritis through the method of randomized grouping experiment,so as to provide the necessary theoretical support for the treatment of acute gouty arthritis with integrated traditional Chinese and Western medicine.Methods:A randomized controlled study was conducted and patients with acute gouty arthritis who were admitted to the outpatients and wards of the Department of Nephrology and rheumatology,the first hospital of traditional Chinese medicine in Baoding,from February 2019 to February 2020 were selected.A total of 90 patients meeting the diagnostic criteria and inclusion criteria were randomly divided into three groups,30 cases in each group,namely,the treatment group(Tongfengning combined with Diclofenac Sodium Enteric-coated Tablets group),the control group 1(Tongfengning group),control group 2(Diclofenac Sodium Enteric-coated Tablets group),the course of treatment was 7 days.The VAS score,joint function score,TCM syndrome score and the corresponding laboratory examination before and after treatment were observed,and the occurrence of adverse reactions were also observed.Data were analyzed by SPSS19.0 software.Result:(1)there were no cases being shed,90 cases were finally enrolled,30 cases in each grouP.(2)VAS score:the VAS scores of the three groups after treatment were(1.77 ±0.57),(1 80 ± 0.48),(1.63 ± 0.67),resPectively.The difference was significant comPared with the VAS before treatment(P < 0.05).There was no significant difference in the imProvement of VAS score among the three groups(P > 0.05).(3)Joint function score: the joint function scores of the three groups after treatment were(0.87 ± 0.51),(1.27 ± 0.64),(1.30 ± 0.65),respectively,which was significantly different from that before treatment(P < 0.05).In terms of the improvement of the joint function of patients,the treatment group was better than the control group 1(P < 0.05)and the control group 2(P < 0.05),and there was no significant difference between the control group 1 and the control group 2(P > 0.05).(4)Laboratoryexamination: After treatment,the blood uric acid in the three groups were(406.00 ± 28.20),(420.10 ± 32.14),(489.07 ± 39.52),respectively,which was significantly different from that before treatment(P < 0.05).In terms of reducing the blood uric acid,the treatment group was superior to the control group 2(P < 0.05),and the control group 1 was superior to the control group 2(P < 0.05),and the treatment group was equivalent to the control group1(P > 0.05).CRP: After treatment,CRP in the three groups were(7.39 ± 2.58),(17.49 ± 5.34),(12.83 ±3.36),respectively.there was a significant difference before and after the treatment(P < 0.05).In terms of reducing CRP,the treatment group was better than the control group 1(P < 0.05),the treatment group was better than the control group2(P < 0.05),and the control group2 was better than the control group 1(P < 0.05).ESR: The ESR in the three groups after treatment were(21.23 ± 6.75),(29.53 ± 9.78),(25.43 ± 5.83),respectively.There was a significant difference before and after the treatment(P < 0.05).In terms of ESR reduction,the treatment group was better than the control group1(P < 0.05)and the control group 2(P< 0.05),the control group 2 was better than the control group 1(P < 0.05).(5)TCM syndrome score: After treatment,the TCM symptom scores in the three groups were(3.97 ± 4.36),(6.60 ± 7.05),(11.17 ± 7.22),respectively.There was a significant difference before and after the treatment(P < 0.05).In terms of reducing TCM symptom scores,the treatment group had the same effect as the control group 1(P > 0.05),the treatment group was better than the control group2(P < 0.05),and the control group 1 was better than the control group 2(P < 0.05).(6)Safety evaluation: There were no significant changes in the stool routine and electrocardiogram of patients in the three groups after treatment compared with that before treatment.During the treatment,1 patient in the treatment group had adverse reactions,with a safety level of 2,while no patient in control group 1 had adverse reactions.5 patients in control group 2 had adverse reactions,among which 4 had a safety level of 2 and 1 had a safety level of 3.There was no significant difference in ALT,AST,BUN and Cr among the three groups before and after treatment(P > 0.05).(7)Total clinical effective rate: 8 patients in the Tongfengning combined with Diclofenac Sodium Enteric-coated Tablets group(treatment group)were cured,and 16 patients had significant effects and 4 patients had effective effects.The total effectiverate was 93.33%.5 Patients in Tongfengning group(control group 1)were cured,and 14 patients had significant effects and 2 patients had effective effects,the total effective rate was70%.In Diclofenac Sodium Enteric-coated Tablets group(control group 2),5 patients were cured,12 patients had significant effects,4 patients had effective effects,the total effective rate was 70%.There were statistically significant differences in the curative effects among the three groups(P < 0.05).The effective rate of Tongfengning combined with Diclofenac Sodium Enteric-coated Tablets group(treatment group)was higher than that of Tongfengning group(control group 1)and Diclofenac Sodium Enteric-coated Tablets group(control group2).Conclusion:Tongfengning combined with Diclofenac Sodium Enteric-coated Tablets has effective effects in the treatment of Damp heat accumulation gouty arthritis.It can not only significantly reduce the clinical symptoms of patients,but also reduce the blood uric acid,ESR,CRP and other indicators.Compared with western medicine or traditional Chinese medicine alone,it is more effective and has higher safety and less adverse reactions,and is worthy of further clinical research and promotion. |
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