Objective To observe clinical efficacy and safety of Jinwu Jiangu Capsules（金乌健骨胶囊） combined with leflunomide in treating patients with rheumatoid arthritis（RA） of cold-dampness obstruction type.Methods A total of 80 RA patients with cold-dampness obstruction type were randomly divided into treatment group and control group

with 40 cases in each group. The control group was given leflunomide orally

20 mg each time

once a day. The treatment group was given Jinwu Jiangu Capsules orally

1. 8 g each time

3 times a day in addition to the treatment of the control group. The course of treatment was 8 weeks. Meloxicam was given if joint pain cannot stand. Changes of traditional Chinese medicine（TCM） syndrome scores

numbers of joint with tenderness

numbers of joint with swelling

morning stiffness time

disease activity scores of 28 joints（DAS-28） scores

visual analogue scale（VAS） scores

erythrocyte sedimentation rates（ESR）

C-reactive protein（CRP）

blood platelet counts（PLT）

Interleukin 6（IL-6）

CD4

+

CD8

+

and CD4

+

/CD8

+

in the 2 groups were observed. Use of meloxicam was counted. The TCM syndrome efficacy and safety were determined. Results Comparison on the TCM syndrome efficacy in the 2 groups showed that

the total effective rate in the treatment group（92. 11%） was higher than that in the control group（72. 97%）（P

<

0. 05）. After the treatment

the TCM syndrome scores

numbers of joint with tenderness

numbers of joint with swelling

morning stiffness time

disease activity scores of 28 joints（DAS-28 scores）

visual analogue scale（VAS）

erythrocyte sedimentation rates（ESR）

C-reactive protein（CRP）

blood platelet counts（PLT）

Interleukin 6（IL-6）

CD4

+

CD4

+

/CD8

+

values

joint synovium thicknesses

joint cavity effusion and synovium blood flow grades in the 2 groups were all lower than those before the treatment（P

<

0. 01 or P

<

0. 05）

and the improvement of the treatment group were superior to that of the control group（P

<

0. 01 or P

<

0. 05）. The CD8

+

was increased after treatment in both groups（P

<

0. 01）

and change of the treatment group was better than that in the control group（P

<

0. 05）. The average total dosage and average medication days of meloxicam in the treatment group were significantly lower than those in the control group（P

<

0. 01）

and no serious adverse reactions were found in either group. Conclusion Jinwu Jiangu Capsules（金乌健骨胶囊） combined with leflunomide can effectively improve joint and systemic symptoms of RA patients of cold-dampness obstruction type

reduce inflammatory indexes

and have good safety

which is better than simply applying leflunomide.