中国中西医结合杂志2025，Vol.45Issue(5)：547-554,8.DOI:10.7661/j.cjim.20250218.131
理气化痰活血方治疗微血管性心绞痛气滞痰阻血瘀证患者随机对照研究
Liqi Huatan Huoxue Formula In the Treatment of Microvascular Angina Patients with Qi Stagnation and Phlegm Obstruction and Blood Stasis Syndrome:A Randomized Controlled Trial
摘要
Abstract
Objective To evaluate the efficacy and safety of Liqi Huatan Huoxue Formula(LHHF)in microvascular angina patients with qi stagnation and phlegm obstruction and blood stasis syndrome(QPBS).Methods Seventy-six patients with microvascular angina with QPBS were randomly assigned to the experimental group(conventional Western medicine treatment+LHHF)and the control group(conventional Western medicine treatment),with 38 patients in each group,and the medication was administered for 4 weeks.The primary outcome were peak oxygen uptake(Peak VO2)in the cardiopulmonary exercise test and Seattle Angina Scale(SAQ)score.The secondary outcomes involved other cardiopulmonary exercise test indices[including metabolic equivalents(MET),oxygen uptake(VO2),a respiratory exchange rate(RER),one-minute heart rate recovery(HRR1),pulse oximetry(VO2/HR),peak exercise load,peak minute ventilation(Peak VE),peak respiratory reserve(Peak BR),oxygen ventilation equivalent(VE/VO2),carbon dioxide ventilation equivalent(VE/VCO2),Borg self-perceived exertion score after exercise(Borg score)],Chinese Medicine syndrome score,and patients' serum vascular endothelial function indexes[including nitric oxide(NO),nitric oxide synthase(eNOS),endothelin-1(ET-1),vascular endothelial calphostin(VE-cadherin),vascular cell adhesion molecule-1(VCAM-1),intercellular adhesion factor-1(ICAM-1)].Safety indexes included blood pressure,electrocardiogram,and laboratory tests were observed.The adverse events were recorded.Results Totally 34 patients in the control group and 36 patients in the experimental group completed the study,and all 76 patients were included in the full analysis set and safety set analysis.Compared with baseline,the total SAQ score,the degree of limitation of physical activity(PL),angina attack(AF),the degree of satisfaction with treatment(TS),the degree of disease perception(DP)score,VO2,MET,HRR1,VO2/HR,peak exercise load,and serum eNOS content were elevated in the two groups after the treatment(P＜0.05,P＜0.01),and the Borg score,serum VE-cadherin,and ICAM-1 content were decreased(P＜0.05,P＜0.01).SAQ angina steady state(AS),Peak VO2,PER,and serum NO content were elevated(P＜0.01),and Peak BR,Chinese Medicine syndrome score,serum ET-1,and VCAM-1 content were decreased in the experimental group(P＜0.05,P＜0.01).Compared with the control group,the total SAQ score,AS,AF,TS,DP score,Peak VO2,VO2,MET,RER,VO2/HR,serum NO,and eNOS content were elevated(P＜0.05,P＜0.01),the levels of Peak BR,Borg score,Chinese Medicine symptoms score,serum VE-cadherin,VCAM-1,and ICAM-1 content decreased in the experimental group after treatment(P＜0.05,P＜0.01).There was no significant difference in the incidence of adverse events between the two groups(P＞0.05).Conclusion LHHF can further improve exercise tolerance,quality of life,and the vascular endothelial function of patients with microvascular angina,and no serious adverse reactions were observed.(Chinese Clinical Trial Register No.ChiCTR2400087241)关键词
冠状动脉微循环障碍/微血管性心绞痛/理气化痰活血方/心肺运动试验/峰值摄氧量/生活质量/运动耐量/血管内皮功能/中药复方/随机对照试验Key words
coronary microcirculation disorders/microvascular angina/Liqi Huatan Huoxue Formula/cardiopulmonary exercise test/peak oxygen uptake/Quality of life/exercise tolerance/endothelial function/Chinese herbal compound/randomized controlled trial引用本文复制引用
葛昭,任思霖,孙玉桓,王贤良..理气化痰活血方治疗微血管性心绞痛气滞痰阻血瘀证患者随机对照研究[J].中国中西医结合杂志,2025,45(5):547-554,8.基金项目
国家自然科学基金面上项目(No.82174326) （No.82174326）
国家中医药管理局中医药创新团队及人才支持计划项目(No.ZYYCXTD-C-202203) （No.ZYYCXTD-C-202203）
天津市卫生计生行业高层次人才选拔培养工程 （）
