养心氏片改善冠心病稳定性心绞痛患者运动耐量的临床疗效观察

Clinical efficacy observation of Yangxinshi tablets in improving exercise tolerance in patients with stable angina pectoris in coronary heart disease

关键词:  冠心病稳定性心绞痛  养心氏片  心肺运动试验  运动耐量  心脏康复

Key words:  stable angina pectoris in coronary heart disease  Yangxinshi tablets  cardiopulmonary exercise test  exercise tolerance  cardiac rehabilitation

摘要:

[目的] 观察养心氏片改善冠心病稳定性心绞痛患者运动耐量的临床疗效。[方法] 将40例冠心病稳定性心绞痛患者，随机分为对照组和治疗组，每组20例。在西药常规治疗的基础上，对照组加用曲美他嗪片（每次20 mg，每日3次），治疗组加用养心氏片（每次3片，每日3次），两组疗程均为4周，访视点为入组时及治疗后4周。以心肺运动试验峰值公斤摄氧量（Peak VO₂/kg）为主要疗效指标，无氧阈代谢当量（METs@AT）、峰值代谢当量（Peak METs）、峰值氧脉搏（Peak VO₂/HR）、摄氧量与功率斜率（VO₂/WR slope）及中医证候积分、心绞痛改善率、西雅图心绞痛量表评分（SAQ）、焦虑筛选量表评分（GAD-7）、抑郁量表评分（PHQ-9）为次要疗效指标，基本生命体征、血常规、肝肾功能、不良事件等为安全性指标。[结果] 两组患者的基线资料比较，差异无统计学意义（P＞0.05），具有可比性。与治疗前比较，治疗组和对照组治疗后4周Peak VO₂/kg、METs@AT、Peak METs、Peak VO₂/HR、VO₂/WR slope、SAQ评分升高，中医证候积分、GAD-7评分、PHQ-9评分降低（P＜0.01）。与对照组同期比较，治疗组治疗后4周Peak VO₂/kg、METs@AT、Peak METs、Peak VO₂/HR、VO₂/WR slope升高（P＜0.05）、SAQ评分中躯体活动受限程度（PL）升高（P＜0.01），中医证候积分降低（P＜0.01）；治疗后4周治疗组和对照组的心绞痛改善率分别为75%和40%，治疗组优于对照组（P＜0.05）。[结论] 在西药常规治疗基础上加用养心氏片，可进一步提高冠心病稳定性心绞痛患者的运动耐量，改善临床症状，提高生活质量，减轻焦虑抑郁情绪，且安全性良好。

Abstract:

[Objective] To explore the clinical efficacy of Yangxinshi tablets in improving exercise tolerance on stable angina pectoris(SAP). [Methods] Forty patients were randomly divided into a control group and a treatment group,20 patients per group. On the basis of Western medicine treatment,the control group was added with trimetazidine(20 mg/Tid),and the treatment group was added with Yangxinshi tablets(3 tablets/Tid),each group had 4 weeks of treatment,the visit points were at the time of enrollment and 4 weeks after treatment. The main therapeutic indicator was the peak VO₂/kg oxygen uptake during cardiopulmonary exercise testing,the secondary therapeutic indicators were the METs@AT,Peak METs,Peak VO₂/HR,VO₂/WR slope,traditional Chinese medicine(TCM) syndrome score,improvement rate of angina pectoris,SAP scale score(SAQ),GAD-7 anxiety screening scale score,and PHQ-9 depression scale score. The safety indicators were the basic vital signs,blood routine,liver and kidney function,adverse events,etc. [Results] Compared with the enrollment,the treatment group and control group had shown an increase in Peak VO₂/kg,METs@AT,Peak METs,Peak VO₂/HR,VO₂/WR slope and SAQ scores;had shown a decrease in TCM syndrome score,GAD-7 anxiety screening scale score,and PHQ-9 depression scale score at 4 weeks after treatment(P＜0.01). Compared with the control group,the treatment group had shown an increase in Peak VO₂/kg METs@AT,Peak METs,Peak VO₂/HR,and VO₂/WR slopes(P＜0.05),physical activity restriction(PL) in SAQ scores(P＜0.01);had shown a decrease in TCM syndrome score(P＜0.01) at 4 weeks after treatment. After 4 weeks of treatment,the improvement rates of angina pectoris in the treatment group and the control group were 75% and 40%(P＜0.05). [Conclusion] On the basis of conventional Western medicine treatment,the addition of Yangxinshi tablets can effectively improve the exercise tolerance level,clinical symptoms and quality of life,reduce their anxiety and depression,and have good safety.