Objective: To evaluate efficacy and safety of intra-articular therapy with methotrexate (MTX) in large volume of 10% glucose injection (GS) in ankylosing spondylitis (AS) patients with knee synovitis.
Methods:As patients with knee synovitis (n=90) were randomly divided into three groups. 50 patients in MTX/GS group were treated with intra-articular injection of MTX (15 mg)in 10% GS (20 ml) every week for 8 times, while 20 patients in GS group with intra-articular injection of 10% GS (20 ml) every week for 8 times, and 20 patients in control group without injection. All the patients received ibuprofen sustained release tablets 0.3 twice daily and Sulphasalazine 1 g twice daily. Same dose of MTX (15 mg once weekly) were given orally to the patients in GS group and control group. At the beginning of the treatment and after 4, 8 and 24 weeks, all the patients underwent a clinical evaluation, measuring maximum flexion-extension angle, knee pain with visual analog scale (VAS), swelling with joint circumference, global assessment (ASA20, PGA, BASMI,BASDAI, BASFI). Erythrocyte sedimentation rate (ESR) and C-reactive protein were tested.Results: Joint pain, range of joint movement, circumference of swollen joint, ESR, CRP, patient's global assessment(PGA) in MTX/GS group are significantly improved after 4 weeks of treatment in comparison with baseline and other groups at same time point (P<0.01-0.05). Adverse reactions in MTX/GS group were less than other groups. No serious adverse events occurred in all the patients. Axial symptoms were no significant difference in three groups. At all-time point, MTX/GS group had better improvement in ASA20, BASMI, BASFI than other groups without statistic difference. No serious adverse events occurred in all the patients. Adverse reactions in MTX/GS group were less than other groups.
Conclusion:Compared to MTX orally taken, the repeated intra-articular injections of MTX glucose solution can suppress knee synovitis earlier and safely in AS patients. The intra-articular therapy of MTX/GS is another option in refractory monoarthritis.