The Evaluation Of Huayu Qiangshen Tongbi Recipe Combined With Methotrexate On The Clinical Efficacy And Bone Protaction In Rheumatoid Arthritis

Objective1.To evaluate Huayu Qiangshen Tongbi Recipe Combined with Methotrexate for Treatment of Patients with RA,and to explore the better combination of Chinese medicine and Western medicine for RA.2.To evaluate the curative effect over bone protection of Huayu Qiangshen Tongbi Recipe with Methotrexate.MethodsThis was a prospective center,open,randomized control,single-trial.One hundred patients meting the all criterias,well understanding and volunteering to join in this trial came from Guangdong Provincial Hospital of Chinese Medicine for May 2016 to September 2018.All eligible patients who treated for 24 weeks were randomly assigned to either the experimental group(HQTR Twice a day,MTX 10-15mg/week)or the control group(LEF 20mg/day,MTX 10-15mg/week).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 gobal assessment of disease activity(PaGADA),physician gobal assessment of disease activity(PhGADA),C-reactive protein(CRP),rheumatoid factor(RF),HAQ score,disease activity score in 28 joints(DAS28)-C-reactive protein(DAS28-CRP),clinical disease activity index(CDAI),simplified disease activity index(SDAI),Sharp-van der Heijde score(SHS),the lumbar spine and left femoral neck bone mineral density and adverse events were analyzed,before and after treatment.ResultsA total of 100 cases were included in this study,including 51 cases of the experimental group and 49 cases in the control group.Results showed that in terms of the main curative effects,the compliance rate of ACR20/50/70 at the time points of 4 weeks,12 weeks,24 weeks and 52 weeks was not significant the difference between the two groups(P>0.05).In terms of other clinical curative effects,DAS28-CRP,CDAI,SDAI,CRP,RF,morning stiffness time,TJC,SJC,HAQ score and other observation indicators showed no significant the difference at each time point between two groups(P>0.05),there had significantly improved in all observation indicators in two groups comparing with the previous time(P<0.05).In terms of prevention of bone destruction,there was no statistically significant difference in SHS score between the two groups(P>0.05),but there was statistically significant difference compared with the previous time in the two groups(P<0.05).BMD values of the lumbar spine and the left femoral neck of showed no statistically significant difference between the groups(P>0.05),and no statistically significant difference compared with the previous time(P>0.05).In terms of safety,the incidence of abnomal liver function in the experimental group was significantly lower than that in the control group(P<0.05).ConclusionAlthough there had no significantly improved in prevention of bone destruction between patients who treated for 52 weeks,the efficacy of HQTR combined MTX which can prevent bone loss and effectively improve the clinical symptoms of patients was equivalent to that of LEF combined MTX.