| Objective:To observe the clinical efficacy and safety of the Wenyanghuoluo decoction combining DMARDs in the treatment of patients with active rheumatoid arthritis(RA).The study aims at seeking for more effective treatment for active rheumatoid arthritis.Method:55 cases patients with cold-dampness syndrome of active RA were enrolled in a randomized trials.The control group involved 28 cases and the treatment group involved 27 cases.The treatment group were treated with Wenyanghuoluo decoction combining DMARDs while the control group were given DMARDs only,with follow-up to 8 weeks.The primary of the end points:ACR(American College of Rheumatology)Criteria and The total curative effect evaluation of Traditional Chinese medicine(TCM).The secondary of the end points:disease activity score using 28 joints(DAS28),tender and swelling joint count,health assessment questionnaire-disability index(HAQ-DI),laboratory tests(CRP)and safety.Results:(1)The proportion of patients with ACR20,ACR50 and ACR70 in treatment group was significantly higher than that in control group:62.96%vs 35.71%(P<0.05),40.74%vs 14.29%(P<0.05)and 14.81%vs 3.57%(P>0.05)respectively;(2)The total curative effect evaluation of TCM:The proportion of patients achieved curative effect evaluation of TCM in treatment group was 96.3%compared with control group was 82.14%(P<0.05);(3)the tenderness joints counts and swelling joints counts declined with treatment(P<0.01),but the treatment group was better than control group(P<0.01);(3)patient’s pain assessment,doctor’s evaluation on patient’s disease activity,patient’s evaluation on self’s disease activity,HAQ-DI DAS28 scores declined with treatment(P<0.01),but the treatment group was better than control group(P<0.01);(4)CRP levels declined with treatment,but the treatment group was better than control group(P<0.01);(5)The adverse events(AEs)in two groups have no difference(P>0.05).Conclusion:The reasearch showed that Wenyanghuoluo decoction combining DMARDs treatment was effiency in reducing signs and symptoms of RA in patients. |