| Objective:The aims of this study is to study and discuss Clinical efficacy and safety and possible mechanism of Traditional Chinese Medicine therapy of clearing heat and promoting blood circulation combined western medicine on active rheumatoid arthritis of stasis heat type,and explore the optimization program of treating rheumatoid arthritis with the combination of Chinese and Western Medicine.Methods:A total of 76 cases of active RA patients with stasis heat type were included in the study by using a randomized, non blind,parallel controlled study, including 38 cases in the observation group and 38 cases in the control group,and them will be followed for 12 weeks.During the observation period, the control group were treated with "MTX+LEF" and taking Diclofenac Sodium Sustained Release Tablets only for pain; Observation group on the basis of the control group of Western Medicine Combined with traditional Chinese medicine "clearing heat and activating blood circulation" method, the selection of Plus and minus"four Miao Yong An "decoction for treatment.Treatment in two groups were recorded before and after the clinical symptoms,signs,erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) and rheumatoid factor (RF), TCM syndrome integral, DAS28 efficacy index, combined with statistical methods are compared, and the clinical efficacy and safety were evaluated.Results:1.A total of 76 patients were enrolled into the study and 71 patients completed the treatment with a withdraw rate of 6.58%. The observation group loss 2 cases while the control group loss 3 case.2.The total effective rate of the treatment group on the levels of DAS28 was 94.44% and in the control group was 88.57%, in which, there was significant difference between the two groups (p<0.05). The total effective rate of the treatment group on TCM syndrome curative effect was 94.44% and in the control group was 62.87%, in which, there was significant difference between the two groups (p<0.05).3.Two groups after treatment ESR, RF, CRP, joint swelling index, joint tenderness index, VAS, DAS28 scores were significantly lower than before treatment, the difference was statistically significant (p<0.05); the observation group was more obvious than the control group (p<0.05).4. Two groups before treatment (0 weeks), treatment (6 weeks), after treatment (12 weeks), the platelet gradually decreased to normal, the difference was statistically significant difference (p<0.01); There was no significant difference between the two groups(p>0.05).5.After treatment in the two groups of the individual symptoms of traditional Chinese medicine were compared with those before treatment improved, statistical significance (p< 0.05); in joint pain, joint swelling, joint tenderness, Inconvenient flexion, morning stiffness, joint fever symptoms, the observation group compared with the control group improved significantly, and the difference was statistically significant (p<0.05), in fever, sweating, Lumbar debility symptoms, the degree of improvement fairly between two group, without obvious difference (p>0.05).6.The observation group use of Diclofenac Sodium Sustained Release Tablets and the number of days of treatment was significantly less than that of the control group, two groups have statistical significance (p<0.01).7.There was no abnormality in the safety index,and before treatment (0 weeks), treatment (6 weeks), after treatment (12 weeks), the difference was not statistically different between the two groups (p>0.05).8.The incidence of adverse reactions in observation group was 8.33%, and the incidence of adverse reactions in the control group was 11.42%, and there was no significant difference between the two groups (p>0.05)Conclusions:1.In lower CRP, ESR, RF, PLT, joint swelling, joint tenderness index, VAS and DAS28 scores for clearing heat promoting blood circulation method combined western medicine treatment of blood stasis type hot RA patients is superior to pure western medicine treatment group.The observation group use of Diclofenac Sodium Sustained Release Tablets and the number of days of treatment was significantly less than that of the control group.2.Clearing heat and activating blood method combined with western medicine treatment in improving patients with joint pain, joint swelling joint tenderness, Inconvenient flexion, morning stiffness, joint fever, thirst, etc. symptoms is better than pure western medicine treatment group.3.Clearing heat and activating blood circulation method combined with western medicine treatment of heat type RA without obvious toxic or side effect or any adverse reaction. |
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