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OBJECTIVE:To investigate the tumor inhibition effect of Yangfei Kongliu Formula (YKF),a compound Chinese herbal medicine,combined with cisplatin (DDP) and its action mechanisms.METHODS:C57BL/6 mice with Lewis lung carcinoma were divided into six groups:control group (C),DDP group (2 mg/kg,DDP),low-dose YKF group (2.43 g/kg,L),high-dose YKF group (24.3 g/kg,H),lowdose YKF combined with DDP group (L + DDP) and high-dose YKF combined with DDP group (H + DDP).Transforming growth factor-β1 (TGF-β1),mothers against decapentaplegic homolog 3 (Smad3) and Smad7 levels were measured with quantitative real-time polymerase chain reaction (qPCR),Westem blotting and immunohistochemistry.An enzyme-linked immunosorbent assay was used to analyze the expressions of interleukin-2 (IL-2) and tumor necrosis factor-α (TNF-α).RESULTS:YKF combined with DDP significantly inhibited the growth and metastasis of tumors relative to the control group,and YKF groups (P ＜ 0.05).There was no significant difference between high-dose YKF group and low-dose YKF group (P ＞ 0.05).We also found that the expression levels of TGF-β1 and Smad3 were both significantly decreased by YKF relative to the control group (P ＜ 0.05).Furthermore,after treatment with YKF combined with DDP,the expression levels of TGF-β1 and Smad3 were decreased but the expression level of Smad7 was increased relative to the DDP group (P ＜ 0.05).Compared to the DDP group,the combination of YKF and DDP enhanced the effect of tumor inhibition (P ＜ 0.05),showing obvious synergy between YKF and DDP.Treatment with DDP or YKF decreased serum levels of IL-2 and TNF-α relative to the control group (P ＜ 0.05).Furthermore,the expression levels of IL-2 and TNF-α were significantly decreased when treated with YKF in combination with DDP.Co-treatment with YKF and DDP significantly inhibited tumor growth,decreased the expressions of TGF-β1,Smad3,IL-2 and TNF-α and increased the expression of Smad7;these differences were significant relative to both YKF groups and the control group (P ＜ 0.05).CONCLUSION:YKF can inhibit tumor growth synergistically with DDP,mainly through the TGF-β1 signaling pathway.