Objective To compare the therapeutic effect and saf et y of Qingre Huoxue Decoction（Decoction for Heat-Clearing and Blood-Quickening） alone with methotrexate（MTX） combined for rheum atoid arthritis（RA）.Methods Totally 142 RA patients o f damp-heat stasis obstru ction syndrome were randomized into Chinese medicine group and Chinese medicine combined with MTX group

with 71 in each.Chinese medicine group accepted Qingre Huoxue Decoction（Decoction for Heat-Clearing and Blood-Quickening） 200ml eac h time

twice daily.Chines e medicine combined with MTX group accepted MTX 10mg each time

once a week in a d dition.The treatment lasted for 24 weeks.The Disease Activity Score 28（DAS28） and Guidelines for the Management of Rheumatoid Arthritis by American College o f Rheumatology（ACR） was used to observe and analyze the therapeutic effect and adverse effect in the beginning

4th

12th and 24th week of the treatment. Results Comparing with before treatment

the scores by DAS28 were decreased significantly in the 12th week of treatment in both groups（P <0.05）.Comparing with 4 weeks after the treatment

the scores by DAS28 were decreased significantly in the 24th week of treatment in both groups（P<0.05）.According to ACR20 and ACR50

the standard reaching rate of Chinese medicine combined with MTX group was si gnificantly higher than that of Chinese medicine group in the 12th week of trea tment（P<0.05）.With the prolongation of treatment

indexes in both groups were improved except for C reactive protein（CRP） and erythrocyte sedimentation rate （ESR）（P<0.05 or P<0.01）.CRP was significantly decreased in the 4th week of tre atment in Chinese medicine combined with MTX group

showing a quicker effect（ P <0.01）.ESR was significantly decreased in the 12th week of treatment in both groups

showing a slower effect（P<0.01）.The incidence of adverse effe ct of Chinese medicine group was lower than that of Chinese medicine combined wi th M TX group.Conclusion Qingre Huoxue Decoction（Decoction for Heat-Clearing and Blood-Quickening） could control the disease activity an d improve the condition of RA patients.It is safer to us e the decoction alone as comparing with MTX combined.But it is suggested to add MTX to improve the condition of RA patients at the earlier stage.