Abstract: AIM: To compare the efficacy and safety of sustained-released tablet of aceclofenac versus aceclofenac in patients with active rheumatoid arthritis (RA). METHODS: Randomized, double-blind, double-simulated, paralleled, and controlled clinical trial was performed. 45 RA patients randomly assigned to two groups (treatment group n =22, controlled group n =23). The treatment group was given sustained- released tablet of aceclofenac 200mg once a day and the controlled group was given aceclofenac 100 mg twice a day. The total course lasted for 4 weeks. RESULTS: The total effective rates of the treatment group and the control group were 63.6 %(n =22) and 69.6 % (n =23), respectively after treatment for 4 weeks. Both drugs could improve the symptoms and signs of RA. The adverse reaction rate was 13.0 %, 12.0 % in the treatment group and control group, there was no statistical significance between the two groups (P > 0.05). CONCLUSION: Sustained-released tablet of aceclofenac is a safe and effective drug, as same as aceclofenac tablet, and also a more convenient drug in treating RA.

Key words: arthritis, rheumatoid, sustained-released tablet of aceclofenac, treatment