| Background:The pathogenesis of rheumatoid arthritis is complicated,and quite a few patients do not respond adequately to first-line slow-acting anti-rheumatic drugs.Under the background of modern medicine emphasizing standard treatment,they need to be transferred to second-line treatment Tofacitinib citrate is a second-line treatment plan.One of them can be used alone or in combination.In China,because these patients are generally older,more women,longer course of disease,and more complicated by other diseases,half of tofacitib citrate is often used clinically to treat the condition.Although tofacitinib citrate has a clear curative effect,there are still insufficient improvements in TCM clinical syndromes and patient outcome reports.TCM has a long history of treating rheumatoid arthritis with definite curative effects.It can improve TCM syndromes and patients through syndrome differentiation and treatment.The final report can make up for its shortcomings in the above-mentioned aspects,and it is more economical.In order to explore the efficacy and safety of Chinese medicine combined with half a dose of tofacitib citrate in the treatment of active rheumatoid arthritis,and to promote the characteristics of Chinese medicine,this study was launched.Objective:To observe the clinical efficacy and safety of Guishao Zhimu Decoction plus Tripterygium wilfordii(Guishao Zhimu Jiateng Decoction for short)combined with tofacitinib citrate on rheumatoid arthritis with complicated cold and heat,and evaluate the overall medical care of patients through patient outcome reports Feel and find a low-cost treatment plan to control active rheumatoid arthritis.Methods:The nursing research objects were 65 patients with active rheumatoid arthritis with mixed cold and heat.The experimental group was treated with Guishuo Zhimu Jiateng Decoction,methotrexate and tolfamtib citrate(5mg/day),while the control group was treated with methotrexate and tolfamtib citrate(10mg/day).The course of treatment for both groups was 12 weeks.The changes of laboratory indicators,the scores of TCM symptoms,the changes of clinical symptoms before and after treatment,the degree of disease activity after treatment,the patient outcome report and the overall clinical efficacy of TCM and Western medicine were compared and analyzed between the experimental group and the control group.The difference of direct medical costs between the two groups was compared by cost-minimization analysis.Outcomes:1.1.Collect 32 cases in the experimental group,complete observation in 30 cases,drop 1 case,and eliminate 1 case;collect 33 cases in the control group,complete observation in 31 cases,and drop out 2 cases.2.Joint tenderness,swelling index,HAQ and VAS scores of experimental group and control group were significantly improved after treatment(P<0.01);Compared with the control group,the experimental group had lower VAS,HAQ score,joint tenderness index and higher number of joint swelling,and the differences were not statistically significant(P>0.05).3.The experimental group and control group after treatment than before treatment c-reactive protein and blood sedimentation and rheumatoid factor were reduced,the index of c-reactive protein and blood sedimentation after treatment was lower than the obvious,established statistical significance(P<0.01),rheumatoid factor is lower than before treatment after treatment is not obvious,the difference does not have statistical significance(P>0.05).Compared with the control group,the C-reactive protein and erythrocyte sedimentation rate were lower in the experimental group,and the rheumatoid factor was higher in the experimental group compared with the control group,and the difference of C-reactive protein between the two groups was statistically significant(P<0.05).4.In terms of disease activity,the DAS-28,CDAI,and SDAI of the two groups were significantly decreased at 4 weeks,8 weeks,and 12 weeks compared with 0 weeks(P<0.01),and at 8 weeks,12 weeks,compared with 4 weeks,they decreased significantly(P<0.01),12 weeks decreased compared with 8 weeks,the difference was not statistically significant(P>0.05).At 4 weeks,the CDAI of the test group was lower than that of the control group,and the difference was statistically significant(P<0.05),the SDAI of the test group was lower than that of the control group,and DAS28 was higher than the control group,and the difference was not statistically significant(P>0.05);8 At 12 weeks,the DAS28,CDAI and SDAI of the test group were lower than those of the control group,and the difference was not statistically significant(P>0.05).5.The TCM syndrome scores of the two groups were significantly lower than before treatment(P<0.01),and the TCM syndrome scores of the experimental group were lower than those of the control group(P<0.05).In terms of individual points,the test group was lower than the control group on the symptom of hand and foot,and the difference was statistically significant(P<0.05).6.The RA-PRO scores of the two groups of rheumatoid arthritis patients were significantly lower than before treatment(P<0.01).In terms of joint fever index,the test group was lower than the control group,and the difference was statistically significant(P<0.05),the difference in the other 10 individual indicators was not statistically significant(P>0.05).7.In terms of overall clinical efficacy,the total effective rate of the two groups of TCM syndromes was 100%,and there was no statistical difference between the groups(P<0.05).The 4,8,and 12 weeks ACR20 remission rate of the experimental group were 63.3%,73.3%,and 90%,respectively,the ACR50 remission rate was 13.3%,43.3%,63.3%,and the ACR70 remission rate was 0.0%,13.3%,20.0%,19.4%.In the control group,the ACR20 remission rates at 4,8,and 12 weeks were 58.1%,74.2%,and 77.4%,respectively,the ACR50 remission rates were 9.7%,48.4%,and 54.8%,and the ACR70 remission rates were 0.0%,9.1%,and 19.4%,respectively.The difference between the groups was not statistically significant(P>0.05)、8.In terms of safety,there were 3 cases of mildly elevated transaminase and 2 cases of gastrointestinal discomfort in the experimental group;2 cases of mildly elevated transaminase and 3 cases of gastrointestinal discomfort in the control group.All returned to normal after symptomatic treatment.9.The minimum cost results of the two groups,the direct medical cost of the trial group for 12 consecutive weeks of treatment(6389.93±341.61 yuan)was lower than that of the control group(7298.99±458.72 yuan)(P<0.01).Conclusion:Clinical studies have found that Guishao Zhimu Jiateng Decoction combined with methotrexate and tofacitinib citrate(5 mg/day)and methotrexate combined with tofacitinib citrate(10 mg/day)can effectively treat cold and heat disorders All types of rheumatoid arthritis can effectively reduce the disease activity,improve the patient’s clinical symptoms and laboratory inflammation-related indicators,and achieve a higher level of clinical remission rate.Compared with the western medicine group alone,the Chinese medicine group has better improvement in patient outcome reports and lower economic costs. |
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