A phase Ⅲ trial of safflor yellow injection for the treatment of angina pectoris with heart-blood stagnation syndrome in patients with coronary heart disease
Abstract：Objective: To evaluate the efficacy and safety of safflor yellow injection for the treatment of an-gina pectoris with heart-blood stagnation syndrome in patients with coronary heart disease (CHD). Methods: A randomized imitative-blind, controlled, and multi-center clinical trial was carried out in 439 patients. Patients were divided into two groups: test group received safflor yellow injection 5 mL (250 mg) in 0.9% NaCl 250 mL (n= 330), and the control group received Honghua injection 20 mL in 0.9% NaCl 250 mL (n=109). After 14-day treatment, the efficacy and safety of salvianolate were evaluated. Results: The total effective rate on angina pectoris analyzed by PP was 91.6% (n=310) in test group, and 69.2% (n=104) in control group (P<0.05). The to-tal effective rate on TCM syndrome analyzed by PP was 91.0% in test group, and 70.2% in control group (P< 0.05). The total effective rate on ECG analyzed by PP was 67.3% in test group, and 61.2% in control group (P>0.05). The results of ITT were the same as those of PP analysis. Adverse events occurred in 5 patients (1.5%) in test group, among which adverse reactions were confirmed in 2 patients (0.6%), but no adverse e-vent was found in control group. No statistically significant change was found between two groups. Conclusion: Safflor yellow injection at a dose of 5 mL is effective and safe for the treatment of angina pectoris with heart-blood stagnation syndrome in patients with CHD.
Keywords：safflor yellow injectioncoronary heart diseaseangina pectorisheart-blood stagnation syn-dromephase Ⅲ clinical trial
Publication Date：2010-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)