宽胸气雾剂治疗冠心病经皮冠状动脉介入术后心功能不全随机对照研究
Randomized Controlled Study of Kuanxiong Aerosol in the Treatment of Cardiac Insufficiency After Percutaneous Coronary Intervention in Coronary Atherosclerotic Heart Disease
林志彬 1屠燕 1滕中华 1邓秋花 1吴慧敏 1李奕彤 2曾庆春1
作者信息
- 1. 南方医科大学南方医院心血管内科(广州 510515)
- 2. 南华大学药学院(湖南 421001)
- 折叠
摘要
目的 探讨宽胸气雾剂治疗冠心病经皮冠状动脉介入术(PCI)后心功能不全患者的临床疗效.方法 将172例冠心病PCI术后心功能不全患者随机分为试验组和对照组,每组86例.两组均接受指南指导性药物治疗,试验组同时接受宽胸气雾剂治疗,治疗1个月.评价两组治疗前后临床疗效及中医证候积分;检测心功能指标左心室射血分数(LVEF)、左心室舒张末内径(LVEDD)、6 min步行试验(6MWT)、血清氨基末端脑钠肽前体(NT-proBNP);西雅图心绞痛问卷(SAQ)评价生活质量.结果 所有患者均完成研究.与本组治疗前比较,两组治疗后中医证候积分、血清NT-proBNP水平降低,6MWT、LVEF、SAQ各维度评分升高(P<0.05).与对照组同期比较,试验组治疗后中医证候积分、血清NT-proBNP水平降低,6MWT、LVEF、SAQ心绞痛稳定状态、心绞痛发作频率、治疗满意程度评分升高(P<0.05).与对照组比较,试验组疗效升高(P<0.01).结论 宽胸气雾剂可改善冠心病PCI术后心功能不全患者心功能、中医证候积分及生活质量.(ClinicalTrials.gov,No.NCT06480097)
Abstract
Objective To explore the clinical efficacy of Kuanxiong Aerosol in the treatment of coronary heart disease(CHD)patients with cardiac insufficiency after percutaneous coronary intervention(PCI).Methods A total of 172 CHD patients with cardiac dysfunction after PCI were randomly assigned to trial group and control group,with 86 cases in each group.Both groups received guideline-directed medical therapy treatment,and the trial group received Kuanxiong Aerosol treatment,the course was 1 month.Clinical efficacy and Chinese medicine syndrome score before and after treatment were evaluated.Cardiac function index including left ventricular ejection fraction(LVEF),left ventricular end-diastolic diameter(LVEDD),6-minute walk test(6MWT),serum N-terminal pro-brain natriuretic peptide(NT-proBNP)were detected.The quality of life was assessed by Seattle Angina Questionnaire(SAQ).Results All patients completed the study.Compared with baseline,the Chinese medicine syndrome score and serum NT-proBNP decreased,and 6MWT,LVEF and each dimension of SAQ increased after treatment in both groups(P<0.05).Compared with the control group in the same period,the Chinese medicine syndrome score and serum NT-proBNP decreased,and 6MWT,LVEF,SAQ angina pectoris stable state,angina pectoris attack frequency and treatment satisfaction increased in the trial group after treatment(P<0.05).Compared with control group,the efficacy of the trial group increased(P<0.01)Conclusions Kuanxiong Aerosol can improve the cardiac function,Chinese medicine syndrome score and quality of life of CHD patients with cardiac insufficiency after PCI.(ClinicalTrials.gov,No.NCT06480097)
关键词
宽胸气雾剂/冠状动脉粥样硬化性心脏病/经皮冠状动脉介入术/心功能不全/中医证候积分/中成药/中西医结合/随机对照试验Key words
Kuanxiong Aerosol/coronary heart disease/percutaneous coronary intervention/cardiac insufficiency/Chinese medicine syndrome score/Chinese patent medicine/integrative medicine/randomized controlled trial引用本文复制引用
出版年
2024