Objective:To observe clinical efficacy of Hanbiting tablet as an additional therapy for rheumatoid arthritis (RA) patients with cold dampness arthralgia spasm syndrome (CDASS) and its influence on levels of interleukin-17(IL-17) and prostaglandin E2 (PGE2 ) in synovial fluid and serum. Method:One hundred and fourteen RA patients of CDASS were randomly divided into control group and treatment group (57 cases each) by random number table. Two groups were given non-drug treatment on the basis of the Diagnosis and Treatment Guidelines of RA. Patients of control group were given methotrexate tablets (10 mg/time

1 time/week) and emulgel tablets (75 mg/time

qd

oral administration after dinner). Besides the therapy of control group

patients in treatment group were additionally treated with Hanbiting tablets with oral administration (3 tablets/time

tid). The course of treatment lasted for 12 weeks for both groups. Scores of traditional Chinese medicine clinical symptoms were compared to evaluated quality of life of patients in two groups by using the Chinese Version of Health Survey Questionnaire Shot Form (SF-36) before and after treatment. The clinical efficacy of both groups were analyzed after treatment

and levels of IL-17 and PGE2 in synovial fluid and serum were detected before and after treatment. Result:Scores of traditional Chinese medicine clinical symptoms in treatment group were all evidently lower than these of control group after treatment (P<0.01). The clinical effective rate of control group was 96.49%

which was superior to 82.46% of treatment group with statistical difference (P<0.05). The scores of SF-36 of treatment group were obviously higher than these of control group after treatment (P<0.01). The levels of IL-17 and PGE2 in the synovial fluid and serum in treatment group were obviously lower than control group with statistical difference (P<0.01). Conclusion:Hanbiting tablet

as an additional therapy for RA patients with CDASS

could remarkably relieve clinical symptoms and improve the quality of life and clinical efficacy. And its mechanism may be related with reducing levels of IL-17 and PGE2 in synovial fluid and serum.