Clinical Research On Prescription Warming Yang To Restore Normal Collateral In Treatment Of Rheumatoid Arthritis

Objectives: To provide clinical evidence for prescriptions warming Yang to restore normal collateral in treatment of rheumatoid arthritis,and evaluate the safety and effectiveness of the prescriptions in treatment of the disease.Methods: A total of 64 outpatients in Yunnan Provincial Hospital of Traditional Chinese Medicine with rheumatoid arthritis of low activity were randomized into 2 groups,control group and treatment group(by using SPSS19.0,random code being 20151228).Methotrexate Tablets were administrated orally for both groups at dose of 10mg/week,in combination with Folic Acid Tablets(once every two days).Besides,a prescription warming Yang to restore normal collateral(in the dose form of Single Concentrated Chinese Herbal Tea,b.i.d)was also given to the treatment group after meal.Symptoms,signs,scores and indicators related to safety and effectiveness were noted prior to the treatment as well as 4 weeks and 8 weeks post treatment,which included ESR,CRP,RF,PGA,MDGA,DAS28 score,TCM syndrome score,CDAI,blood routine tests,urine routine tests,fecal routine tests,liver and kidney functions and ECG.On the basis of statistical analysis,TCM syndrome score and symptom relief were used to assess the improvement of syndrome and primary symptoms of patients,and rate of satisfying ACR20 standards was used to evaluate the safety and preliminary effectiveness of the prescription.Results: Improvement in symptoms,signs and disease activity indicators(ESR?CRP?DAS28?CDAI)was shown in both groups,with that of the treatment group greater than the control group(P<0.05)and no significant difference in RF shown between prior to and post treatment(P>0.05).Total effectiveness rate for the improvement in TCM syndrome was 93.3% and 78.2%for the treatment group and control group,respectively,and the ones for symptom improvement was 80.0% and 40.6% for the treatment group and control group,respectively.With the rate of meeting ACR20 standard,it was 80.0% and 34.3% for the treatment group and control group,respectively.No abnormity was revealed for both groups in terms of blood tests,urine tests,fecal tests,liver and kidney functions and ECG.Rate of adverse reactions was revealed to be 3.0% and9.4% for the treatment group and control group,respectively.Conclusion: 1.Prescription warming Yang to restore normal collateral,in combination with Methotrexate Tablets,was effective in improving symptoms and signs,reducing VAS score,TCM syndrome score and RA activity,enhancing rate of satisfying ACR20 standards,for the treatment of RA due to cold-dampness stasis.2.The prescription in combination with Methotrexate Tablets was proven to be safe,with no toxic reaction observed and adverse reactions of Methotrexate reduced.