Objective To observe the effect and safety of Bufei Tongluo Wan （Bolus for tonifying the lung and removing obstruction of meridians） combined with methotrexate on rheumatoid arthritis associated interstitial lung disease （RA-ILD） in an early stage.Methods Sixty-four patients were randomized into two groups with 32 in each.The observation group was treated with Bufei Tongluo Wan and methotrexate for oral taking

while the control group treated with methotrexate only in continuation.After treatment for six months

the indices of lung function and changes in high resolution computer tomography （HRCT） of both groups were compared to observe the effect.Results After treatment

the total lung capacity （TLC） and diffusing capacity carbon monoxide （DLCO） of the observation group were significantly improved （P<0.01）; and its HRCT score was reduced （P<0.05）.The result of TLC

DLCO

and HRCT of the two groups in comparison after treatment showed statistical difference （P<0.01 or P<0.05）.Conclusion Bufei Tongluo Wan combined with methotrexate in the treatment of RA-ILD in an early stage is effective in improving the lung function and decreasing the area of interstitial lung lesions with a good safety.