Effect of Yiqi Liangxue Shengji Formula （益气凉血生肌方） on Recurrence of Angina Pectoris and Quality of Life after Percutaneous Coronary Intervention in Coronary Heart Disease Patients with Qi Deficiency and Blood Stasis Syndrome and Binding of Stasis and Heat Syndrome： A Randomized， Triple-blind， Placebo-controlled Parallel Trial / 中医杂志

ABSTRACT

ObjectiveTo observe the clinical effect of Yiqi Liangxue Shengji Formula （益气凉血生肌方， YLSF） on recurrence of angina pectoris and quality of life at eight weeks after perecutaneous coronary intervention （PCI）. MethodsEighty-two coronary artery disease （CAD） patients with qi deficiency and blood stasis and binding of stasis and heat syndrome who had underwent PCI were randomly divided into two groups with 41 patients each in the treatment group and the control group. Based on conventional western medicine after PCI， patients in the treatment group orally took YLSF granules while those in the control group were administered with placebo， one dose daily for 8 weeks. The recurrence rate of angina pectoris and readmission rate within eight weeks after PCI were recorded. Before and after treatment， total traditional Chinese medicine （TCM） syndrome score， Seattle Angina Questionnaire （SAQ） scores （physical limitation， angina stability， angina frequency， treatment satisfaction and disease perception）， and the SF-36 scores for quality of life （physical and mental health） were evaluated. The adverse reactions during medication in both groups were recorded. ResultsWithin eight weeks after PCI， the recurrence rate of angina pectoris in the treatment group （4/41， 9.76%） was significantly lower than that in the control group （11/41， 26.83%， P＜0.05）. The readmission rate in the treatment group was 2.44% （1/41）， while that in the control group was 12.20% （5/41）， with no significantly statistical difference （P＞0.05）. After treatment， total TCM syndrome score significantly decreased in both groups， while in terms of quality of life， the SAQ scores on domains of angina stability， angina frequency and disease perception as well as SF-36 total scores， physical health and mental health scores significantly increased （P＜0.05 or P＜0.01）. Compared between the two groups， total TCM syndrome score was significantly lower in the treatment group than the control group （P＜0.01）， while no significant differences were found in SAQ scores and SF-36 total， physical and mental health scores （P＞0.05）. No adverse reactions occurred in both groups during the treatment period. ConclusionYLSF can reduce the recurrence rate of angina pectoris within eight weeks after PCI for coronary artery disease， and can improve the TCM syndrome score， and have sound safety， with comparable effect to that of placebo in improving postoperative short-term quality of life.