Objective: To discuss the curative efficacy of compound Xuanzhu capsules combined with recombinant human tumor necrosis factor-α receptorⅡ:IgG fusion protein in treating rheumatoid arthritis (RA) patients of Shen and Qi deficiency syndrome. Method: Ninety-two patients with RA were randomly divided into the conventional treatment group

the control group and the combination group by random number table. Patients in conventional treatment group received celebrex

0.2 g

once daily

methotrexate tablets

10 mg

once weekly

and leflunomide tablets

20 mg

once daily for oral administration. Based on the treatment of the conventional treatment group

patients in the control group added recombinant human tumor necrosis factor-α receptorⅡ:IgG Fc fusion protein for articular cavity injection once weekly. Based on the treatment of control group

patients in combination group added compound Xuanzhu capsules

3 gains

thrice daily. All patients received 3-month treatment. Before and after treatment

numbers of swollen and tender joint (28 joints) were recorded and pain degree was assessed by visual analogue scales. Scores of morning stiffness

grip strength and Shen deficiency cold syndrome were recorded. Levels of erythrocyte sedimentation rate (ESR)

c-reactive protein (CRP)

rheumatoid factor (RF)

tumor necrosis factor (TNF-α)

a1-acidoglycoprotein (a1-AGP) and immune globulin (IgA

IgM

IgG) were detected. Result: After treatment

the clinical total effective rate in the conventional treatment group

the control group and the combined group were 79.31%

90% and 96.97%

respectively. There was no statistically significant difference between any two of the three groups. The improvements of time of morning stiffness

grip strength

the number of hands rest pain

joint swelling

joint tenderness count for the control group were superior to those for the conventional treatment group (P<0.01). The improvements of hard-shelled time in the morning

grip strength

the number of hands rest pain

joint swelling

joint tenderness count for patients in the combined group were superior to those of the conventional treatment group (P<0.01). The improvements of morning stiffness time

hands grip strength

rest pain and Shen deficiency cold syndrome scores for the combined group were superior to those for the control group(P<0.05). Levels of TNF-α

RF

a1-AGP for the control group were lower than those in the conventional treatment group

while levels of ESR

CRP

TNF-α

RF and a1-AGP for the combined group were inferior to those for the conventional treatment group after treatment (P<0.05). Levels of ESR

CRP

TNF-α

RF and a1-AGP for combined group were lower than those for the conventional treatment group after treatment (P<0.05

P<0.01). IgG level for the control group was less than that in the conventional treatment group (P<0.01). IgA

IgM

IgG of the combined group were inferior to those in the conventional treatment group and the control group (P<0.01). Conclusion: Compound Xuanju capsules combined recombinant human tumor necrosis factor-α receptorⅡ:IgG Fc fusion protein could control symptoms

improve joint function

reduce syndromes and command inflammation.