| Objective To observe the clinical efficacy and safety of taking methotrexate(MTX)and leflunomide(LEF)combined with traditional Chinese medicine fumigation therapy in the treatment of rheumatoi arthritis(RA)patients,to explore the immune mechanism of combined treatment of RA with Chinese and western medicine,and to provide reference for clinical treatment of RA.Methods Sixty-three patients of RA who treated in the department of rheumatology and immunology of Linyi Hospital of traditional Chinese medicine and met the requirements from August 2018 to March 2019,they were selected and divided into Chinese and western medicine group,Chinese medicine group and western medicine group randomly,and 21 patients in each group.Western medicine group was given conventional drugs MTX 12mg/7days and LEF 8mg/day;Chinese medicine group was treated with traditional Chinese medicine fumigation,36min/time,twice/day,7 days for a course of treatment,84days in total.The group of Chinese and western medicine was further treated with traditional Chinese medicine fumigation on the basis of conventional western medicine treatment.Clinical symptoms of traditional Chinese medicine,number of symptoms of swollen joint count(SJC),number of joint tenderness(TJC),duration of morning stiffness,visual analogue scale(VAS),patients globa-assessment(PGA),doctors globa-assessment(DGA),health assessment questionnaire(HAQ)score;laboratory of CD4~+/CD8~+Tcells,proportion of Th17/Treg subsets,tumor necrosis factor alpha(TNF-α),interleukin17(IL-17),interleukin10(IL-10),erythrocyte sesedimentation rate(ESR),rheumatoid factor(Ig G-RF),serum amyloid-A(SAA)were recorded before and after the experiment of each group respectively.Clinical efficacy was determined by ACR20,50,70 and other scoring criteria recommended by the American college of rheumatology(ACR)and the guidelines for clinical research on rheumatoid arthritis treated with new Chinese herbals,and the course of the experiment was closely monitored.Blood cell classification count plus reticulum erythrocyte,urine dry chemistry plus sediment,urea nitrogen,creatinine,transaminase,heart rate and pulse detection as safety guarantee.At the end of the experiment,all the test results were compared and analyzed using SPSS19.0 statistical software.Result 12 weeks after the treatment,(1)Th17/Treg,IL-17,CD4~+/CD8~+,TNF-α,SAA and ESR were decreased,with significantly(P<0.01);Ig G-RF was decreased and IL-10 was increased of the Chinese and western medicine group,compared with that before treatment,with significantly difference(P<0.05);Th17/Treg,IL-17,CD4~+/CD8~+,Ig G-RF,TNF-α,SAA and ESR were decreased,and IL-10 was increased in western medicine group and the Chinese medicine group,compared with those before the treatment,with significant(P<0.05);compared the differences beteen the groups,the decrease of Th17/Treg,IL-17,TNF-α,ESR and SAA in the Chinese and western medicine group were significantly higher than that in Chinese group and western medicine group,with significant difference(P<0.05).(2)SJC,TJC and morning stiffness time in Chinese and western medicine group were significantly lower than those before treatment,and SJC and morning stiffness time were significantly different(P<0.01),TJC was significantly different(P<0.05);SJC,TJC and stiffness time in Chinese group and western medicine group were significantly lower than those before treatment,with significantly difference(P<0.05);the SJC,TJC and morning stiffness time in Chinese and western medicine group were significantly decreased than that in Chinese group and western medicine group(P<0.05).(3)The scores of PGA,DGA and VAS in Chinese and western medicine group were lower than those before treatment,and the scores of PGA and DGA were significantly different(P<0.01),the scores of the VAS was significantly different(P<0.05);the scores of DGA,PGA and VAS in Chinese group and western medicine group were lower than those before treatment(P<0.05),PGA and DGA decreased significantly in Chinese and western medicine groups compared with the Chinese group and western medicine group(P<0.05).(4)The cold and hot sense,dry mouth bitter,sleepiness and weight,short red urine/long clear urine,dry stool/loose stool score were decreased compared with those before treatment in the all groups,and there were differences(P<0.05),the dry mouth bitter score of Chinese and western medicine group decreased more than that of Chinese and western medicine group and there was a significant difference among the three groups(P<0.05);HAQ scores in all groups were significantly lower than those before treatment(P<0.05).(5)the effective rate of symptoms of traditional Chinese medicine syndrome was 90.47%in Chinese and western medicine group,76.19%in western medicine group and 85.71%in Chinese medicine group.The total improvement rate of ACR20,ACR50 and ACR70 in Chinese and western medicine group was 80.95%,61.90%in western medicine group and 66.67%in Chinese group.Safety indexes of patients in each group during and after treatment were detected,and no obvious irreversible toxic and side effects were found.Conclusion(1)MTX/LEF combined with CTM fumigation therapy can significantly reduce the inflammatory responses of patients with rheumatoid arthritis and effectively alleviate the symptoms of the disease.This therapy can further improve clinical efficacy with high tolerance and less side effects.(2)Through adjusting the imbalance of CD4~+/CD8~+and Th17/Treg ratio of T lymphocyte subsets and increasing the release of anti-inflammatory cytokine IL-10,and restraining the expression of Inflammatory factor IL-17and TNF-α,MTX/LEF combined with fumigation therapy of traditional Chinese medici e further plays an anti-inflammatory role.Therefore,this therapy is better than western medicine or Chinese medicine fumigation exclusively. |
