Abstract: Objective To investigate the effects of different doses of modified Shaoganfuzi Decoction on inflammatory cytokines and safety indexes in rats with collagen-induced arthritis, and to study its efficacy and safety. Methods Thirty-six Wistar rats were randomly divided into 6 groups according to their body weight: normal group, CIA model group, control group, and traditional Chinese medicine group with low, medium and high dose groups, with 6 rats in each group. The normal group was fed routinely, after the CIA cold syndrome model was replicated in the other groups, the model group was gavaged with normal saline, the control group was gavaged with Tripterygium wilfordii polyglycosides (6.25 mg·kg^-1), and the traditional Chinese medicine group was given low, medium and high doses of modified Shaoganfuzi decoction. (0.625 g·mL^-1, 1.25 g·mL^-1, 2.5 g·mL^-1) were intragastrically administered and intervened for 4 weeks. The joint inflammation index score, the pathological changes of the ankle joint synovium and the peripheral blood inflammatory cytokine IL-6 were measured in each group. levels, and cardiac (troponin), liver (CK18, HMGB1, GLDH), kidney (NGAL, cystatin C) early warning and routine safety indicators. Results After 4 weeks of intervention, the AI scores of the middle and high dose groups of modifined Shaoganfuzi Decoction were significantly lower than those of the CIA model group (P<0.05). Stenosis, synovial cell hyperplasia, lymphocyte infiltration and articular surface damage were alleviated; serum IL-6 levels in the middle and high doses of modifined Shaoganfuzi decoction groups were lower than those in the CIA model group (P<0.05); peripheral blood biochemical changes of rats in each group There was no significant difference in the indexes and the levels of CK18, HMGB1 and cystatin C between the groups; the levels of GLDH in the control group and the low, middle and high doses of traditional Chinese medicine groups were lower than those in the normal group (P<0.05); the levels of NGAL in the control group were higher than those in the normal group (P<0.05); the levels of troponin in the control group and low-dose group were lower than those in the normal group (P<0.05). Conclusion Modified Shaoganfuzi Decoction has no toxic effects on the heart, liver and kidney, and can reduce joint swelling and IL-6 level, which provides the basis for subsequent research and clinical application.

Key words: collagen-induced arthritis, rheumatoid arthritis, modified Shaoganfuzi decoction, warming meridians and collaterals, safety