OBJECTIVE: To explore the effects and safety of Hedan tablets on the levels of blood lipid, inflammatory factors and oxidative stress in coronary heart disease (CHD) patients with type 2 diabetes mellitus (DM2). METHODS: A total of 118 patients diagnosed as CHD with DM2 were collected from our hospital during Jul. 2013-Nov. 2015, and then divided into observation group (63 cases) and control group (55 cases) according to random number table. Control group received conventional treatment such as controlling blood glucose, regulating blood lipid, vasodilator, anticoagulant. Observation group additionally received Hedan tablets 1.46 g before meal, tid, on the basis of control group. Both groups received treatment for 6 months. The levels of blood lipid (TC, TG, LDL-C, HDL-C), serum inflammatory factors (TNF-α, IL-10, IL-6, hs-CRP) and oxidative stress indexes (MDA, SOD, NO) before and after treatment as well as the occurrence of ADR were compared in 2 groups. RESULTS: Before treatment, there was no statistical significance in levels of blood lipid, serum inflammatory factors or oxidative stress indexes between 2 groups (P>0.05). After treatment, the serum levels of TC, TG, LDL-C, TNF-α, IL-6, hs-CRP and MDA in 2 groups were decreased significantly, while those of IL-10, SOD and NO were increased significantly; the observation group was significantly better than the control group, with statistical significance (P<0.05). There was no statistical significance in the incidence of ADR between 2 groups (P>0.05). CONCLUSIONS: Hedan tablets can effectively improve the level of blood lipid, reduce the level of inflammatory factors, relieve inflammatory injury, reduce the level of oxygen free radical, strengthen antioxidant capacity and lighten oxidative stress injury with good safety.