| BackgroundRheumatoid arthritis(RA)is a systemic autoimmune disease characterized by persistent and progressive peripheral synovitis and pannus formation.Its persistent inflammation affects bone remodeling,leading to progressive bone destruction,and eventually lead to joint deformity and function loss with high morbidity.EULAR proposed "treat-to-target" concept in 2010,which is to take clinical remission,radiology and functional relief as the treatment goals of RA,and for the long-term disease patients,low disease activity can be used as an alternative target.With the promotion of new drugs such as biological agents and the continuous improvement of treatment strategies,the treat-to-target rate of RA was significantly improved.Then EULAR updated the concept of "treat-to-target" to maintain"sustained" remission or low disease activity in RA treatment management recommendations in 2016.In clinical practice,we found that RA patients with clinical remission or low disease activity continued to develop joint damages.It is particularly important to choose a treatment regimen that has long-term and effective control of clinical symptoms and minimizes radiological progression in patients with moderate to long-term RA who have achieved clinical remission or low disease activity.In this study,we analyzed the clinical data of the RA patients who have achieved clinical remission or low disease activity treated by methotrexate(MTX,MTX group),Xiao Wu Gui granule combined with MTX(Xiao Wu Gui group),Technetium-99 tertiary diphosphine(99Tc-MDP)combined with MTX(99Tc-MDP group),or recombinant human tumor necrosis factor receptor-antibody fusion protein(rhTNRF:Fc)combined with MTX(rhTNRF:Fc group),to evaluate the long-term clinical efficacy,radiotherapy efficacy and safety of these four treatment regimens,and to provide clinical evidence for treat-to-target of RA.objectiveTo describe the long-term clinical efficacy,radiotherapy efficacy and safety of Xiao Wu Gui granule,99Tc-MDP,rhTNRF:Fc combination with MTX treatments in RA patients who have achieved clinical remission or low disease activity.Methods1 Patients and methodsBetween January 2014 and April 2017,a total of 115 RA patients were recruited from RA patients visited the hospital rheumatology outpatient department and inpatient department in Southern Medical University of Nanfang.All patients met the American Rheumatism Association(ACR)1987 revised criteria for the classification of rheumatoid arthritis.2 Outcomes measures2.1 The chief efficacy of criteriaIncluding the 52 weeks continued compliance rate based on DAS28-CRP,modified Sharp score and TCM arthralgia syndromes(morning stiffness,arthralgia,joint swelling,joint chills and limb heavy).2.2 The auxiliary efficacy of criteriaThe 13,26 and 39 weeks continued compliance rate based on DAS28-CRP,recurrence rate and 12 week sustained recurrence rate,TCM arthralgia syndromes scores total improvement rate,progress rate of radiology and disease evaluation indicators RF and anti-CCP.2.3.Safety assessmentIncluding auxiliary examination(blood,liver and kidney function,urine),adverse reactions and routine physical examination.4.Statistical method MeasurementContinuous data were expressed as mean ± SD.The variance analysis of repeated measurement data and t test were used to compare contents in different groups;enumeration data were expressed as n and%,using chi-square test and t test to compare contents in different groups.We used SPSS20.0 statistical analysis software.P<0.05 was considered to be statistically significant.Results1 Baseline dataThere were no significant differences in the baseline data of sex,age and cause of disease,modified Sharp score,DAS28-CRP,RF,anti-CCP between groups.2 Efficacy measuresThe 52 weeks continued compliance rate of Xiaowugui particals group,99Tc-MDP group and rhTNRF:Fc group were higher than that of MTX group(57.14%,73.33%,75%VS 40%).The differences between 99Tc-MDP group,rhTNRF:Fc group and MTX group was statistically significant(?2=3.911,4.711;P=0.048,0.03).The rhTNRF:Fc group was superior to MTX group in the 26 and 39 weeks continued compliance rate(x2=4.311,4.531;P=0.038,0.033).The 12 week sustained recurrence rate of Xiaowugui particals group,99Tc-MDP group and rhTNRF:Fc group were lower than that of MTX group(17.86%,10%,9.38%VS 36%),and the 99Tc-MDP group,rhTNRF:Fc group compared with MTX group,and the differences were statistically significant(x2=5.404,5.986;P=0.02,0.014).The Xiaowugui particals group was superior to MTX group and 99Tc-MDP group in TCM arthralgia syndromes scores improvement rate,and the differences were statistically significant(x2=4.821,4.261;P=0.028,0.039).Compared the Xiaowugui particals group with 99Tc-MDP group 5 rhTNRF:Fc group and MTX group in the improvement of joint chills,the differences were statistically significant(t=-3.81,-3.318,-3.195;P<0.001,P=0.002,0.002).Compared the Xiaowugui particals group with 99Tc-MDP group,rhTNRF:Fc group and MTX group in the improvement of limb heavy,the difference were statistically significant(t=-4.821,-4.598,-4.446;P<0.001,<0.001,<0.001).The modified Sharp score of 99Tc-MDP group was significantly lower than that of MTX group(t=-2.575;P=0.013).3 Safety assessmentIn the MTX group,3 cases had mild liver function abnormality and 1 case had loss of appetite.9 cases(36%)of 99Tc-MDP group had short-term mild calcium deficiency and 1 case had bloating in Xiaowugui particals group.During the observation period,there were no significant differences in blood routine,urine,liver function and renal function between groups.Conclusion99Tc-MDP,rhTNRF:Fc combined with MTX maintenance therapy can effectively control the recurrence of the disease,and achieve higher 52 weeks continuous compliance rate than MTX therapy alone.rhTNRF:Fc combined with MTX can get higher 26 and 39 weeks continuous compliance rate.99Tc-MDP combined with MTX treatment can significantly delay radiological progression and partially repairing bone destruction.Xiaowugui particals have clear effects on the cold dampness blocking type RA patients and significantly improve the clinical symptoms of joint chills and limb heavy.Xiaowugui particals,99Tc-MDP,rhTNRF:Fc combined with MTX maintenance therapy have good safety. |
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