Short-Term Efficacy And Safety Of TCM External Treatment Combined With Biological Agents In The Treatment Of Active Rheumatoid Arthritis

ObjectiveTo observe the short-term clinical efficacy and safety of 34patients with active rheumatoid arthritis（RA）treated with etanercept combined with TCM external treatment.MethodsA total of 68 RA patients admitted to the Department of Rheumatology,Wuhan First Hospital from August 2020 to December2021 were selected as the study subjects.All patients failed traditional disease-modifying antirheumatic drugs（DMARDs）treatment and were first treated with biological disease-modifying antirheumatic drugs（b DMARDs）.All patients were divided into observation group and control group by random number table method.The observation group was treated with Tongbi ointment external application combined with etanercept and methotrexate,while the control group was only treated with etanercept combined with methotrexate.Both groups were treated for 3 months.DAS28 score before treatment in 2 groups was analyzed.Clinical symptoms,including swelling joint count（SJC）and tenderness joint count（TJC）;Inflammatory response levels and cytokines levels,including erythrocyte sedimentation rate（ESR）,C-reactive protein（CRP）,tumor necrosis factorα（TNF-α）,interleukin 6（IL-6）,interleukin 10（IL-10）.After treatment,the changes of the above indicators were compared between the two groups,and the clinical efficacy and adverse reactions were analyzed and compared between the two groups.ResultsAfter short-term treatment,the effective rate of the observation group was 73.53%,and that of the control group was64.71%,there was no statistical significance between the two groups（P>0.05）.However,the rate of good treatment response in the observation group（44.12%）was better than that in the control group,and the difference was statistically significant（c~2=4.30,P=0.04）.The adverse reaction rates of the observation group and the control group were 11.8%,5.9%,respectively,and no serious adverse reactions occurred.There was no statistical significance in the adverse reaction rates between the two groups（P>0.05）.There were no significant differences in DAS28 score,joint swelling number and joint tenderness number between 2 groups before treatment（all P>0.05）.After treatment,the disease scores of2 groups were significantly decreased,and the number of joint swelling and joint tenderness were significantly decreased,and the observation group was lower than the control group（all P<0.05）.There was no significant difference in disease activity before treatment between 2 groups（P>0.05）.There was statistically significant difference in disease activity between the two groups1 month after treatment（P<0.05）,but there was no significant difference in disease activity between the two groups 3 months after treatment（P>0.05）.There were no significant differences in ESR,CRP,TNF-α,IL-6 and IL-10 levels between 2 groups before treatment（P>0.05）.After treatment,the levels of ESR,CRP,TNF-α,IL-6and IL-10 in 2 groups were significantly decreased,and the observation group was lower than the control group（all P<0.05）.LimitationsThis study was a single-center observational study,without discussing the long-term efficacy and long-term adverse reactions of treatment regimens,and with a small number of cases,a large-sample,multi-center,randomized controlled study is expected.ConclusionThe combination of etanercept and Tongbi ointment for the treatment of RA patients in the active stage can achieve the purpose of inducing and relieving the disease at an earlier stage,improve the patients’response to treatment,reduce joint pain and joint swelling,promote the reduction of inflammatory factors,and do not significantly increase the adverse reactions,so it is relatively safe and effective.