OBJECTIVE:To evaluate the effect of Yiqi Liangxue Shengji prescription(益气凉血生肌方,YQLXSJ)on cardiac function and outcomes in acute myocardial infarction(AMI)patients with myocardial ischemiareperfusion injury(MIRI...OBJECTIVE:To evaluate the effect of Yiqi Liangxue Shengji prescription(益气凉血生肌方,YQLXSJ)on cardiac function and outcomes in acute myocardial infarction(AMI)patients with myocardial ischemiareperfusion injury(MIRI)and to determine its clinical efficacy.METHODS:This prospective,randomized,double-blind,placebo-controlled trial enrolled hospitalized patients with AMI who underwent percutaneous coronary intervention and experienced MIRI either intraoperatively or postoperatively.Participants were randomly allocated to the treatment group,which received YQLXSJ,or the control group,which received a placebo,concurrent with standard Western Medicine therapy.The intervention period lasted 8 weeks.The primary outcome measure was left ventricular ejection fraction(LVEF),determined by echocardiography.Secondary outcomes included Nterminal pro brain natriuretic peptide(NT-pro BNP)and cardiac troponin I(cTnI)levels,left ventricular internal diameter,major adverse cardiovascular events(MACE),angina pectoris scores,and Chinese medicine evidence scores.RESULTS:Following 8 weeks of intervention,the treatment group demonstrated a significant increase in LVEF and a marked reduction in NT-pro BNP when compared to the control group.There was also a significant decrease in peak cTnI levels,Chinese medicine evidence scores,and angina pectoris scores.The control group's left ventricular end-systolic diameter(LVESD)significantly increased compared to baseline after 8 weeks(P<0.05),whereas the treatment group's LVESD showed no significant change from baseline(P>0.05).Although the treatment group showed a downward trend in MACE incidence compared to the control group,this difference was not statistically significant(P>0.05).CONCLUSIONS:This study demonstrated that the addition of YQLXSJ to standard therapy can improve cardiac function and alleviate clinical symptoms in AMI patients with MIRI,and also showed a potential to mitigate the incidence of MACE.Furthermore,YQLXSJ displayed a favorable safety profile in clinical application.展开更多
OBJECTIVE: To assess the efficacy and safety in patients with chronic heart failure(CHF) of Western medication plus Traditional Chinese Medicine(TCM) preparations.METHODS: This prospective, single-blind, randomized, c...OBJECTIVE: To assess the efficacy and safety in patients with chronic heart failure(CHF) of Western medication plus Traditional Chinese Medicine(TCM) preparations.METHODS: This prospective, single-blind, randomized, controlled, and multicenter clinical trial began on September 17, 2008, and was completed on June 25, 2011. A total of 340 inpatients, aged 40-79 years, with exacerbating CHF from 10 hospitals were enrolled and randomly allocated within 24 h of admission. The trial included three intervention periods. During hospitalization, the control group received western medication for CHF and the treatment group received Danhong injection with Shenfu injection or Shenmai injection. After discharge,all patients were treated with Qiliqiangxin capsules and Buyiqiangxin tablets or a placebo for 6 months. After the 6-month intervention, both groups received only continuous western medication. The primary endpoint was all-cause mortality.The efficacy assessments were as follows: B-type natriuretic peptide(BNP), Lee's HF score, the 6-minute walking test(6 MWT), left ventricular ejection fraction(LVEF), and the Minnesota Living with Heart Failure Questionnaire(MLHFQ). The safety assessments were as follows: blood and urine routine examination, hepatic and renal function, electrolytes in blood and adverse events.RESULTS: Compared with the control group, the treatment group showed a 30.99% reduction in all-cause mortality and an improved survival rate.The treatment group showed greater improvement in 6 MWT(P = 0.02) than the control group on discharge, after 12-month follow-up, there was a time-group interaction for MLHFQ(P = 0.03). Incidence rate of adverse events and other relevant safety indexes were not statistically significant between the two groups.CONCLUSION: Western medication plus TCM treatment can increase 6-minute walking distance(improve exercise tolerance) and quality of life with heart failure patients.展开更多
基金Supported by the Capital’s Funds for Health Improvement and Research:Clinical Study on Yiqi Liangxue Shengji Prescription for Improving Cardiac Function after Myocardial Ischemia Reperfusion Injury in Patients with Acute Myocardial Infarction(CFH 2020-4-4204)Beijing University of Traditional Chinese Medicine Qihuang Yingcai·Excellent Young Science and Technology Talent Cultivation Program(K2023A03)Beijing University of Traditional Chinese Medicine Dongfang Hospital High-level Capacity Building Project"Zhuoyuan"Project National Talent Precision Cultivation Program(DFRCZY-2024GJRC012)。
文摘OBJECTIVE:To evaluate the effect of Yiqi Liangxue Shengji prescription(益气凉血生肌方,YQLXSJ)on cardiac function and outcomes in acute myocardial infarction(AMI)patients with myocardial ischemiareperfusion injury(MIRI)and to determine its clinical efficacy.METHODS:This prospective,randomized,double-blind,placebo-controlled trial enrolled hospitalized patients with AMI who underwent percutaneous coronary intervention and experienced MIRI either intraoperatively or postoperatively.Participants were randomly allocated to the treatment group,which received YQLXSJ,or the control group,which received a placebo,concurrent with standard Western Medicine therapy.The intervention period lasted 8 weeks.The primary outcome measure was left ventricular ejection fraction(LVEF),determined by echocardiography.Secondary outcomes included Nterminal pro brain natriuretic peptide(NT-pro BNP)and cardiac troponin I(cTnI)levels,left ventricular internal diameter,major adverse cardiovascular events(MACE),angina pectoris scores,and Chinese medicine evidence scores.RESULTS:Following 8 weeks of intervention,the treatment group demonstrated a significant increase in LVEF and a marked reduction in NT-pro BNP when compared to the control group.There was also a significant decrease in peak cTnI levels,Chinese medicine evidence scores,and angina pectoris scores.The control group's left ventricular end-systolic diameter(LVESD)significantly increased compared to baseline after 8 weeks(P<0.05),whereas the treatment group's LVESD showed no significant change from baseline(P>0.05).Although the treatment group showed a downward trend in MACE incidence compared to the control group,this difference was not statistically significant(P>0.05).CONCLUSIONS:This study demonstrated that the addition of YQLXSJ to standard therapy can improve cardiac function and alleviate clinical symptoms in AMI patients with MIRI,and also showed a potential to mitigate the incidence of MACE.Furthermore,YQLXSJ displayed a favorable safety profile in clinical application.
基金Supported by National Key Technology R&D Programs in the 11th Five-Year Plan of China:Study on Comprehensive Evaluation Method of Integral Effect of Traditional Chinese Medicine Treatment for Heart Failure(No.2006BAI08B02-01)Ministry of Education of People's Republic of China"Program for Innovative Research Team in University"–Research on TCM for the Prevention and Treatment of Cardiovascular Diseases(No.IRT_16R54)Tianjin Science and Technology Program:Tianjin TCM Clinical Medicine Research Center(No.15ZXLCSY00020)
文摘OBJECTIVE: To assess the efficacy and safety in patients with chronic heart failure(CHF) of Western medication plus Traditional Chinese Medicine(TCM) preparations.METHODS: This prospective, single-blind, randomized, controlled, and multicenter clinical trial began on September 17, 2008, and was completed on June 25, 2011. A total of 340 inpatients, aged 40-79 years, with exacerbating CHF from 10 hospitals were enrolled and randomly allocated within 24 h of admission. The trial included three intervention periods. During hospitalization, the control group received western medication for CHF and the treatment group received Danhong injection with Shenfu injection or Shenmai injection. After discharge,all patients were treated with Qiliqiangxin capsules and Buyiqiangxin tablets or a placebo for 6 months. After the 6-month intervention, both groups received only continuous western medication. The primary endpoint was all-cause mortality.The efficacy assessments were as follows: B-type natriuretic peptide(BNP), Lee's HF score, the 6-minute walking test(6 MWT), left ventricular ejection fraction(LVEF), and the Minnesota Living with Heart Failure Questionnaire(MLHFQ). The safety assessments were as follows: blood and urine routine examination, hepatic and renal function, electrolytes in blood and adverse events.RESULTS: Compared with the control group, the treatment group showed a 30.99% reduction in all-cause mortality and an improved survival rate.The treatment group showed greater improvement in 6 MWT(P = 0.02) than the control group on discharge, after 12-month follow-up, there was a time-group interaction for MLHFQ(P = 0.03). Incidence rate of adverse events and other relevant safety indexes were not statistically significant between the two groups.CONCLUSION: Western medication plus TCM treatment can increase 6-minute walking distance(improve exercise tolerance) and quality of life with heart failure patients.
