OBJECTIVE: To observe the clinical efficacy and safety of tanshinone ⅡA sulfonate in the treatment of coronary atherosclerotic heart disease (CHD) angina. METHODS: 46 patients with CHD angina were included in efficacy evaluation group, and randomly assigned into trial group (23 cases) and control group (23 cases); other 45 patients with CHD angina were enrolled into safety evaluation group. All of them were treated with conventional therapy of isosorbide dinitrate, aspirin and β receptor blocker, etc.; trial group was additionally given Tanshinone ⅡA sulfonate injection intravenously, qd, for consecutive 4 d on the basis of routine therapy. The frequency and period of angina attacks, ECG before and after treatment and potential ADR were observed in 2 groups. Safety evaluation group were treated with Tanshinone ⅡA sulfonate injection with same dosage and frequency as trial group, but treatment course was not limited; only the occurrence of ADR was observed in the group. RESULTS: The total effective rates of clinical efficacy and ECG in trial group were 86.96% and 69.56%, which were significantly higher than the control group (65.22%, 43.48%), with statistical significance (P<0.05). Compared with control group, the frequency and period of angina attacks reduced significantly in trial group after treatment, with statistical significance (P<0.01). No ADR was observed in 68 patients treated with intravenous dripping of Tanshinone ⅡA sulfonate injection. CONCLUSIONS: Based on routine therapy, Tanshinone ⅡA sulfonate injection can effectively improve the clinical symptom of CHD angina, with good safety.