Clinical Analysis Of Zhengqing Fengtongning Sustained Release Tablets For The Treatment Of Patients With Rheumatoid Arthritis

ObjectiveThe aim of this study was to evaluate the efficacy and safety of Zhengqing Fengtongning sustained release tablets(ZQFTN)combined with Methotrexate(MTX)in patients with rheumatoid arthritis.MethodsThis was a single center,open,randomized control,prospective trial.In this trial,all of RA patients came from Guangdong Provincial Hospital of Chinese Medicine for July 2015 to December 2017,who met the inclusion and exclusion criteria,well understood this trial and volunteered for this trial.RA patients with moderate or high disease activity that were randomly assigned to either the treatment group(ZQFTN 120mg/day,MTX 10-15mg/week)or the control group(LEF 20mg/day,MTX 10-15mg/week).For all the two groups,nonsteroidal anti-inflammatory drugs(NSAIDs),glucocorticoid,folic acid tablet,calcitriol/calcium carbonate and antacids were allowed during the research.All patients were treated for 24 weeks.American College of Rheumatology(ACR)20/50/70 response rate as the main outcome indicators would be analyzed after treatment between the two groups.Moreover,the 28-joint tender joint count(TJC28),swollen joint count(SJC28),the duration of morning stiffness,the visual analogue scale(VAS),patient global assessment of disease activity(Pa GADA),physician global assessment of disease activity(Ph GADA),C-reactive protein(CRP),rheumatoid factor(RF),HAQ score,disease activity score in 28 joints(DAS28)-C-reactive protein(CRP)and adverse events were analyzed,before and after treatment.SPSS17.0 statistical software package was used to establish the database,and the data were analyzed using t test,rank sum test,chi-square test and Repeated ANOVA.ResultsA total of 120 patients were enrolled in this trial,the cases numbers of two groups were 73 cases and 47 cases.Up to now,98 patients completed 24 weeks of treatment,59 cases in treatment group and 39 cases in control group.There was no significant differences in demographic characteristics and the clinical features before treatment between the two groups(P>0.05).In our study,TJC28,SJC28,morning stiffness time,VAS,Pa GADA,Ph GADA,CRP,RF,HAQ score and DAS28-CRP of two group were significantly improved after treatment than those before(P<0.01).No significant differences within two groups in the ACR20/50/70 by analysis by per-protocol subjects analysis(PPS)(P>0.05).The clinical and laboratory indexes were no statistically difference between the two groups(P>0.05)after4-week-treatment.After 12 weeks of treatment,there were no significant differences in SJC28,VAS,Pa GADA,Ph GADA,CRP,HAQ score and DAS28-CRP between two groups(P>0.05).However,the improvement of TJC28 and morning stiffness time in the control group were better than the treatment group after12-week-treatment(P<0.05).Similarly,no significant differences within two groups in the improvement of TJC28,SJC28,CRP,RF,HAQ score,Pa GADA,DAS28-CRP and imaging evaluation after 24 weeks of treatment(P>0.05),and the improvement of the VAS,Ph GADA,and RF in the treatment group was better than the control group(P<0.05).During the treatment,adverse events occurred 32 cases in control group,and 27 cases occurred in treatment group,there were significant differences in adverse events between the two groups(P<0.05),which showed that the rate of hepatic enzyme increased and gastrointestinal was more frequent in the control group.ConclusionsThe clinical efficacy of ZQFTN combined with MTX were equivalent to that of LEF combined with MTX.With a beneficial clinical response and acceptable tolerability,ZQFTN may be a good therapeutic option in combination with MTX in RA treatment.