Abstract: OBJECTIVE To observe effect of Shuangjiang Decoction combined with atorvastatin on carotid atherosclerotic plaque. METHODS 107 patients with carotid atherosclerotic plaque were randomly divided into four groups. The basic treatment was based on low-salt and low-fat diet. The hard-plaque group 1 and soft-plaque group 1 were treated with oral atorvastation daily 20 mg， while hard-plaque group 2 and soft-plaque group 2 were given Shuangjiang Decoction on the basis of 20 mg of atorvastation. One dose per day orally， each group was continuously taken for 12 weeks. The serum monocyte chemoattractant protein-1 (MCP-1)， macrophage migration inhibitory factor (MIF)， matrix metalloproteinase-1 (MMP-1)， matrix metalloproteinase-9 (MMP-9)， nuclear factor-κBp65 (NF-κBp65)， transforming growth factor-β1(TGF-β1) levels， plaque area and TCM syndrome scores of two groups were observed before and after treatment. RESULTS High levels of cellular inflammatory factors MCP-1， MIF， NF-κBp65， TGF-β1 and proteases MMP-1 and MMP-9 were observed in the serum of each group. Compared with hard-plaque group 1 and 2 with Shuangjiang Decoction before treatment， the level of MCP-1， MIF， NF-κBp65， MMP-1， MMP-9 in soft-plaque group 1 and 2 with Shuangjiang Decoction were higher， while TGF-β1 levels were decreased (P<0.01). Compared with the pre-treatment group， the level of MCP-1， MIF， NF-κBp65， MMP-1， MMP-9 in the serum of hard-plaque group 1 and soft-plaque group 1 were increased， while the level of TGF-β1 was decreased (P<0.05). The changes of hard-plaque group 2 and soft-plaque group 2 with Shuangjiang Decoction were especially significant(P<0.01). Compared with hard-plaque group 2 with Shuangjiang Decoction after treatment， the levels of MCP-1， MIF， NF-κBp65， MMP-1 and MMP-9 in soft-plaque group 2 with Shuangjiang Decoction were increased， while the level of TGF-β1 was decreased (P<0.05). Compared with pre-treatment， the area of carotid plaque in group 1 of hard-plaque and soft-plaque group 1 was reduced (P<0.05)， and in group 2 of hard-plaque and soft-plaque with Shuangjiang Decoction was also reduced (P<0.01). The area of the cartoid plaque in soft-plaque group 2 with Shuangjiang Decoction was better than that in hard-plaque group 2 with Shuangjiang Decoction (P<0.05). After treatment， each group can reduce the TCM syndrome scores. Compared with the hard-plaque group 1 and soft-plaque group 1， the hard-plaque group 2 and soft-plaque group 2 with Shuangjiang Decoction can significantly reduce TCM syndrome scores in patients with carotid atherosclerosis (P<0.05). CONCLUSION Cytoinflammatory factors MCP-1， MIF， NF-κBp65， TGF-β1 and proteases MMP-1 and MMP-9 are involved in the regulation of carotid atherosclerosis. Shuangjiang Decoction and atorvastatin can effectively reduce carotid plaque area and significantly improve carotid plaque. Patients with TCM syndromes， the combination of the two is more effective， and its mechanism may be related to lowering serum MCP-1， MIF， MMP-1， MMP-9， NF-κBp65 levels and increasing serum TGF1 levels.