Objective To observe the clinical curative effects and safety of Musk-Aconite-Earthworm Pill（ 麝香乌龙丸） treating patients with rheumatoid arthritis. Methods Randomly divided 114 cases of patients with rheumatoid arthritis into the treatment group（ 59 cases） and the control group（ 55 cases）. Patients in two groups all took Leflunomide Tablets

10 mg per time

twice every day. The treatment group adopted Musk-Aconite-Earthworm Pill additionally on this basis

3 g every time

twice every day; the control group took Total Glucosides of Paeony Capsules（白芍总苷胶囊） additionally

0. 6 g every time

three times every day; two groups were both treated for 2 months.Compared clinical curative effects of two groups and observed all symptoms including number of joint with swelling

tender joint count

morning stiffness duration

TCM score

pain index

patients’ overall assessment of illness condition

and experimental indexes including Rheumatoid factor（ RF）

erythrocyte sedimentation rate（ ESR）

c-reactive protein（ CRP）

anti cyclic citrullinated peptide antibody（ anti CCP antibody） before

one and two months after treatment. Results The total effective rate in the treatment group was 91. 53 %

while that of the control group was89. 09 %. The difference of constituent ratio of curative effects rank in two groups had statistical significance（ P <0. 05）

with the treatment group superior to the control group. Number of joint with swelling

tender joint count

morning stiffness duration

TCM score

pain index

patients’ overall assessment of illness condition of patients in two groups one month after treatment all remarkably decreased compared with that before treatment（ P < 0. 05）. Abovementioned indexes in two groups two months after treatment all remarkably decreased compared with that before and one month after treatment（ P < 0. 05）. Number of joint with swelling

tender joint count

TCM score

pain index

patients’ overall assessment of illness condition in the treatment group one month after treatment were all superior to that of the control group（ P < 0. 05）. The improvement of the number of joint with swelling

tender joint count

TCM score

pain index

patients’ overall assessment of illness condition of the patients in the treatment group two months after treatment was superior to that of the control group while the improvement of morning stiffness duration in the control group was superior to that of the treatment group（ both P < 0. 05）; the difference between number of joint with swelling

RF

ESR

CRP and anti CCP antibody in two groups after treatment had no statistical significance（P > 0. 05）. There appeared no serious adverse reactions on patients in two groups. Conclusion Musk-AconiteEarthworm Pill could rapidly relieve acute symptoms of patients with rheumatoid arthritis. It had exact clinical curative effects and high safety.