OBJECTIVETo study the therapeutic effect and possible mechanism of total panax notoginseng saponins (PNS) for treatment of rheumatoid arthritis (RA), and to observe its safety and influence on RA immune related inner environment.

METHODSEighty-four patients were randomly assigned to two groups. All were treated with the routine therapy with diclofenac sodium, Leflunomide and prednisone, but for the 43 patients in the treatment group PNS was given additionally. The therapeutic course was 28 days for both groups. Clinical efficacy and change of indexes including platelet counts, immnuoglobulins (IgG, IgA, IgM), complement (C)3, rheumatoid factor (RF), C-reactive protein (CRP), ceruloplasmin (CER), haptoglobin (HPT), and alpha1-acid glycoprotein (AAG) were observed.

RESULTSSignificant improvement of clinical symptoms, including the joint swelling index, joint tenderness index, joint pain index, time of morning stiffness and VAS revealed in both groups after treatment, and the effect in the treatment group was better (P<0.05 or P<0.01). PLT, CER, AAG, HPT, CRP, IgG, IgA, IgM, C3 and RF were lowered in both groups (P<0.01), but the lowering in PLT, CER, AAG and CRP in the treatment group was more significant than that in the control group respectively (P < 0.05 or P < 0.01).

CONCLUSIONPNS can significantly improve the condition of patients, enhance the therapeutic effect in treating RA, through regulating the disordered immunity and improving the effect of anti-inflammatory and analgesia.