Qiong Zhang1, Jian-Hua Peng, Xiang-nong Zhang. 1. The National Clinical Base of Drug Research, Xiyuan Hospital, China Academy of Traditional Chinese Medicine, Beijing 100091, China. zhangq810@263.net
Abstract
OBJECTIVE: To evaluate the clinical effect and safety of Safflower Yellow injection (SYI) in treating coronary heart disease angina pectoris (CHD-AP) with Xin-blood stagnation syndrome (XBSS). METHODS: Adopted was the multi-centered, randomized, positive parallel controlled method, 448 patients with CHD-AP-XBSS were enrolled and divided into two groups, 336 in the tested group treated with SYI and 112 in the control group treated with Salvia injection by intravenous dripping once a day for 14 days, so as to observe the conditions of angina, electrocardiogram, and therapeutic effect on traditional Chinese medicine (TCM) symptoms as well as the safety of the treatment. RESULTS: The significantly effective rate and total effective rate in the tested group were 60.06% (194/323) and 91.02% (294/323) respectively; Those in improvement of TCM symptoms were 40.18% (129/321) and 75.23% (243/323) respectively, which were better than those in the control group (P < 0.01). CONCLUSION:SYI Injection is effective and safe in treating CHD-AP-XBSS.
RCT Entities:
OBJECTIVE: To evaluate the clinical effect and safety of Safflower Yellow injection (SYI) in treating coronary heart disease angina pectoris (CHD-AP) with Xin-blood stagnation syndrome (XBSS). METHODS: Adopted was the multi-centered, randomized, positive parallel controlled method, 448 patients with CHD-AP-XBSS were enrolled and divided into two groups, 336 in the tested group treated with SYI and 112 in the control group treated with Salvia injection by intravenous dripping once a day for 14 days, so as to observe the conditions of angina, electrocardiogram, and therapeutic effect on traditional Chinese medicine (TCM) symptoms as well as the safety of the treatment. RESULTS: The significantly effective rate and total effective rate in the tested group were 60.06% (194/323) and 91.02% (294/323) respectively; Those in improvement of TCM symptoms were 40.18% (129/321) and 75.23% (243/323) respectively, which were better than those in the control group (P < 0.01). CONCLUSION: SYI Injection is effective and safe in treating CHD-AP-XBSS.