Therapeutic Effect Of Bitongkang Pill Combined With Methotrexate On Rheumatoid Arthritis And Its Influence On IL-6 And TNF-α

Objective To observe the clinical efficacy of Bitongkang pill combined with methotrexate in the treatment of RA with cold and dampness obstruction,and the effect on the expression of pro-inflammatory factors IL-6 and TNF-α,so as to screen the traditional Chinese medicine with high level of evidence for the standard treatment of RA with traditional Chinese medicine.Methods Sixty-four patients with RA who were admitted to the outpatient department of rheumatism and immunology and wards of Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine from December 2019 to January 2021 were selected as patients who met the Western medicine diagnostic criteria of RA and were classified as cold dampness bizoobstruction by TCM syndrome differentiation.Sixty-four RA patients who met the inclusion criteria were randomly divided into the treatment group and the control group(and the comparison of general data was not statistically significant and comparable).The treatment group was given Bitongkang pill combined with methotrexate tablets,while the control group was given methotrexate tablets.For treatment of 12 weeks record general situation,including:age,gender,duration,0(baseline),4 weeks,12 weeks,the detection of erythrocyte sedimentation rate(ESR),rheumatoid factor(RF-IgM),c-reactive protein(CRP),and record count(SW28),tenderness joint swelling of the joints(T28),morning stiffness time,patients’ pain score(VAS score),IL-6,TNF alpha.DAS28 score,HAQ total score,and remission rate under DAS28 remission criteria were calculated.Results At baseline,there were no significant differences in mean age,sex,disease duration,morning stiffness time,T28,SW28,ESR,CRP,RF-IGM,DAS28,HAQ,VAS,IL-6,TNF-α between the treatment group and the control group(P>0.05).At 4 and 12 weeks of treatment,ESR,CRP,RF-IGM,T28,SW28,morning stiffness time,DAS28,HAQ,VAS,IL-6 and TNF-α in 2 groups were all decreased compared with baseline,with statistical significance(P<0.05).At 4 weeks,there was no significant difference between the two groups except HAQ(P>0.05),and the other observation indexes in the treatment group were lower than those in the control group,with statistical differences(P<0.05).After 12 weeks of treatment,there were statistical differences in all the observed indexes between the two groups(P<0.05).After 12 weeks of treatment,the remission rate of the treatment group was 84.4%,and that of the control group was 43.8%.The remission rate of the treatment group was better than that of the control group,with statistical difference(P<0.05).Conclusion 1.Bitongkang pill combined with MTX is better than MTX alone in the treatment of RA patients with cold dampness obstruction.Bitongkang pill combined with MTX regimen had better inhibitory effect on pro-inflammatory factors(IL-6,TNF-α)in RA patients than MTX alone.Especially in the longer term treatment,Bitongkang pill has more obvious advantages in reducing inflammatory indexes,improving joint symptoms and improving quality of life,suggesting that Bitongkang pill has a more stable and sustained anti-inflammatory effect in the treatment of cold-dampness Bi type RA.2.According to the EULAR response criteria,Bitongkang pill combined with MTX resulted in better remission than MTX alone in patients with cold-dampness rheumatoid RA.