OBJECTIVE: To observe the efficacy of Guizhi Shaoyao Zhimu decoction combined with methotrexate in the treatment of rheumatoid arthritis（ RA） in active phase

and to analyze efficacy-related factor. METHODS:Totally 126 patients with RA in active phase admitted into General Hospital of Eastern theater of PLA from Dec. 2016 to Dec. 2019 were selected and divided into observation group and control group via random number table

with 63 cases in each group. The control group was treated with methotrexate

while the observation group was given Guizhi Shaoyao Zhimu decoction based on the control group

the courses of treatment of both groups were 12 weeks. Serum rheumatoid factor（ RF）

C reactive protein（ CRP） and erythrocyte sedimentation rate（ ESR） levels were detected

and the efficacy was evaluated by RA patient’s condition evaluation（ DAS28 score）; the number of tender joints

swollen joints and other clinical data were recorded. RESULTS: After 6 weeks and 12 weeks of treatment

the serum CRP and ESR levels of both groups had been significantly decreased

the serum CRP and ESR levels after 12 weeks of treatment were significantly lower than after 6 weeks of treatment

and those of observation group were significantly lower than the control group during the same period

with statistically significant differences（ P < 0. 05）. After 6 weeks and 12 weeks of treatment

the serum RF level of observation group were significantly lower than those of before treatment

the serum RF level after 12 weeks of treatment were significantly lower than after 6 weeks of treatment

and that of observation group was significantly lower than the control group during the same period

with statistically significant differences（ P < 0. 05）. After12 weeks of treatment

the total effective rate of observation group was 92. 07%（ 58/63）

which was significantly higher than that of the control group（ 79. 37%

50/63）

with statistically significant difference（ P <0. 05）. After 6 weeks and 12 weeks of treatment

the TCM syndrome integral of both groups were significantly lower than those of before treatment

the TCM syndrome integral after 12 weeks of treatment were significantly lower than after 6 weeks of treatment

and that of observation group was significantly lower than the control group during the same period

with statistically significant differences（ P < 0. 05）. The efficacy was related to patient’s gender

age

number of tender joints and swollen joints before treatment

course of disease

presence or absence of rheumatoid nodules and drug combination

serum RF

CRP and ESR levels before treatment; number of tender joints and swollen joints before treatment

course of disease

presence or absence of rheumatoid nodules and drug combination（ Guizhi Shaoyao Zhimu decoction combined with methotrexate）

serum RF and ESR levels before treatment were the independent factors that affect the efficacy. CONCLUSIONS: The efficacy of Guizhi Shaoyao Zhimu decoction combined with methotrexate in the treatment of RA in active phase is remarkable. Number of tender joints and swollen joints before treatment

course of disease

presence or absence of rheumatoid nodules and drug combination（ Guizhi Shaoyao Zhimu decoction combined with methotrexate）

serum RF and ESR levels before treatment were the independent factors that affect the efficacy.