OBJECTIVE: To observe the effects of Danggui Sini decoction on the expression of inflammatory factors in mice with scleroderma

and to probe into the regulatory mechanism of Danggui Sini decoction affecting scleroderma through Toll-like receptor 4（TLR4）/nuclear factor kappa B（NF-κB） signal pathway. METHODS: A total of 60 BALB/c mice were extracted to be divided into the blank control group

the model control group

the positive control group and the Danggui Sini decoction group（high-dose

medium-dose and low-dose group） via the random number table

with 10 cases in each group. Mice in the model control group

positive control group and Danggui Sini decoction group were given given subcutaneous injection of bleomycin hydrochloride 0. 1 ml to establish the sclerderma model mice

and the blank control group was given 0. 1 ml 0. 9% sodium chloride injection for 3 weeks. On the 5th day after the establishment of the model

mice in the high-dose

medium-dose and low-dose group were given 16

8 and 4 g/kg Danggui Sini decoction by gavage. mice in the positive control group were given prednisone 0. 2 g/kg by gavage

and the blank control group and the model control group were given the same volume of 5 ml distilled water for gavage

each group was given drugs once a day

for 3 weeks. The mice were sacrificed 24h after the last administration

and the expression levels of tumor necrosis factor α（TNF-α）

interleukin 10（IL-10） and interleukin16（IL-16） in each group were determined

changes of TLR4

NF-κB protein expression were detected. RESULTS:After modeling

mice in the model control group showed various degrees of increase in skin thickness

atrophy of hair follicles

and disordered organization of dermal tissues. Compared with the blank control group

the serum levels of TNF-α

IL-10 and IL-16 in the model control group were significantly increased

and the expression levels of TLR4 and NF-κB protein in skin tissues were significantly increased

with statistically significant differences（P< 0. 05）.Compared with the model control group

the skin pathological damage in the positive control group and the Danggui Sini decoction group was alleviated to different degrees; the serum levels of TNF-α

IL-10 and IL-16 were significantly reduced

and the expression levels of TLR4 and NF-κB in skin tissues were significantly reduced

with statistically significant differences（P < 0. 05）. The therapeutic effects of Danggui Sini decoction were dose-dependent.CONCLUSIONS: Danggui Sini decoction can effectively regulate the content of inflammatory factors such as TNF-α

IL-10 and IL-16 in scleroderma model mice

regulate the expression of TLR4/NF-κB signaling protein

and effectively protect the skin tissues of scleroderma model mice.