RESUMEN
ObjectiveTo investigate the clinical effect of Guanxin Shutong capsules （GXSTC） on coronary heart failure with heart blood stasis. MethodA total of 98 coronary heart failure patients with heart blood stasis who visited the expert clinics of the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine from June 2020 to August 2022 were selected. They were randomized into a control group and an observation group， with 49 in each group. The two groups were given standardized treatment according to the guidelines for coronary heart failure. On this basis， the observation group was treated with Chinese patent medicine GXSTC. The cardiac structural and functional indicators， total effective rate of symptoms， exercise tolerance， heart rate variability （HRV）， quality of life and inflammatory factor levels of the two groups before and after treatment were compared. ResultBefore treatment， there was no notable difference in high-sensitivity C-reactive protein （hs-CRP）， six minute walk test （6MWT）， minnesota living with heart failure questionnaire （MLHFQ） score， left ventricular ejection fraction （LVEF）， tumor necrosis factor-α （TNF-α）， left ventricular end-diastolic diameter （LVEDD）， N-terminal pro-brain natriuretic peptide （NT-proBNP） and HRV between the two groups， and thus the data were comparable. After treatment， the observation group had higher effective rates of traditional Chinese medicine （TCM） symptoms （Z=-2.362， P<0.05） and New York heart association class （NYHA） functional classes （Z=-2.175， P<0.05） than the control group. The two groups presented decreased LVEDD， TNF-α， NT-proBNP and hs-CRP （P<0.05， P<0.01） while increased MLHFQ， 6MWT and HRV（P<0.05，P<0.01） after treatment as compared with those before treatment， and the observation group had more decrease or increase than the control group （P<0.05， P<0.01）. ConclusionGXSTC combined with standardized treatment relieves the physical symptoms of coronary heart failure patients with heart blood stasis， improves exercise tolerance and quality of life， reduces inflammatory reaction， increases HRV， and improves cardiac structure and function.
RESUMEN
This study aims to comprehensively summarize articles on the treatment of coronary heart disease angina pectoris with heart blood stasis syndrome(CHD-AP-HBSS) by Guanxin Shutong Capsules(GSC), and comprehensively evaluate the evidence and value of the formula in "6+1" dimensions based on multi-criteria decision analysis(MCDA) model and Guidelines for Management of Comprehensive Clinical Evaluation of Drugs(trial version 2021) with quantitative and qualitative methods, which is expected to highlight the clinical characteristics and advantages of the prescription and serve as a reference for medical and health departments. The dimensions are grade A, B, C, or D. In terms of safety, according to the reports from the spontaneous reporting system of National Center for ADR Monitoring, and literature analysis, GSC mainly results in the adverse reactions of mild or moderate nausea, diarrhea, rash, palpitation, and headache, with favorable prognosis in patients. Nevertheless, severe adverse reactions have been reported after marketing. Thus, additional evidence for its safety should be accumulated, and the current safety is grade B. Meta-analysis proves that GSC in combination with conventional treatment is superior to conventional treatment alone in alleviating AP and symptoms indicated by electrocardiogram(ECG). Therefore, the effectiveness of the medicine is grade A. As for the pharmacoeconomic value, based on the assumption that the per capita disposable income in 2020 is the willingness-to-pay threshold, it is more economical for CHD-AP patients to use GSC combined with conventional treatment than conventional treatment alone. However, as the currently available clinical parameters fail to support the difference in indirect cost between the two groups, the accuracy in the cost of intervention plan needs to be further improved. Therefore, the economy of the prescription is grade B. GSC has been awarded 13 national invention patents and 1 utility model patent, and won a lot of national and provincial patent awards, marking the enterprise service awareness and innovativeness. As a result, it is grade A in aspect of innovation. A questionnaire on the suitability of GSC suggests that publicity and promotion influence patients' choice and thus additional efforts should be made in this aspect. The suitability of this formula is grade B. Both rural and urban residents can afford the medicine for the whole course and the price is close to that of similar Chinese patent medicines. In addition, it is accessible regardless of season and place, so accessibility is grade A. As a Mongolian empirical formula destined to treat heart stabbing pain, it has the effects of activating blood and resolving stasis, dredging channels and activating collaterals, and moving Qi to relieve pain, and boasts the empirical evidence of more than 2 000 human cases. With prominent characteristics of traditional Chinese medicine, it is grade B. Based on the MCDA model and CSC v2.0, GSC is comprehensively class A in the treatment of CHD-AP-HBSS. The result can serve as a reference for basic clinical medication management.