世界中医药

作者	单位
孙飞龙1，2，袁炜婷1，2，赵高娃2，3，曹雅兰1，2，向姝婷1，2，王钰2，4，于勤1，2	1 遵义医科大学,遵义,563000 2 大连大学附属中山医院,大连,116001 3 大连大学，116622； 4 大连医科大学,大连,116044

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中文摘要:

目的：观察中成药养心氏片在对慢性心力衰竭患者优化药物治疗的基础上，对心功能、心脏结构以及运动中血压和心率的影响。方法:采用随机、对照试验方法，选取2017年10月至2018年5月间入大连大学附属中山医院住院并知情同意的慢性急性失代偿性心力衰竭患者80例作为研究对象，在病情稳定2～4周后，心力衰竭优化药物达到最大耐受量的基础上随机分为4组：对照组（n=30）、养心氏组（n=30）、曲美他嗪组（n=10）以及养心氏+曲美他嗪组（n=10），各组年龄及性别无统计学意义，观察期为6个月，分别在第0、6个月进行心肺运动试验及心脏超声检查。结果：6个月后，对照组心肺运动试验、心脏超声各项参数与基线比较，差异无统计学意义（P均>0.05），养心氏组、曲美他嗪组及养心氏+曲美他嗪组心肺运动试验（MET）、心脏超声(SV、LVFS和LVEF）较基线及与同期对照组比较显著提高，心脏超声(LVESV、LVEDV）较基线及与同期对照组比较显著降低（P均<0.05）；养心氏组和养心氏+曲美他嗪组心肺运动试验（运动中最高血压、最大心率、心率变化率）较基线及同期对照组比较显著降低（P均<0.05），而曲美他嗪组与基线及与对照组比较，差异无统计学意义（P均>0.05）；养心氏组、养心氏+曲美他嗪组在心肺运动试验及心脏超声各项指标组间比较，差异无统计学意义（P均>0.05），4组心肺运动试验（静息收缩压、舒张压、脉压差、静息心率）较基线均无显著变化（P均>0.05）。结论：用药6个月，养心氏与曲美他嗪都可以在优化药物治疗基础上显著改善慢性心力衰竭患者心脏收缩功能，逆转心肌重塑，提高慢性心力衰竭患者运动耐量，对静息血压、心率无显著影响，且养心氏能够降低运动中的最大收缩压、最大心率及心率变化率，使慢性心力衰竭患者更容易耐受运动状态，但两者联合较任何单一用药无额外获益。

English Summary:

To observe the effects of Yangxinshi on quality of life，cardiac function and exercise tolerance in patients with chronic heart failure.Methods:A prospective，randomized and controlled clinical study was conducted.Eighty consecutive patients with acute decompensated heart failure who were admitted to Zhongshan Hospital Affiliated to Dalian University from October 2017 to May 2018 and taking a turn for the better 2-4 weeks later were randomly divided into the control group(n＝30)，the Yangxinshi group(n＝30)，the trimetazidine group(n＝10）and the Yangxinshi+ trimetazidine group(n＝10).The observation period was 6 months.All patients were surveyed by cardiopulmonary exercise test，ultrasonic cardiogram at baseline and 6 months after treatment(Clinical Trial Registration Number：NCT03333499).Results:At baseline，there was no significant difference in each observation index between the 4 groups.There was no significant difference in the parameters of exercise test and ultrasonic cardiogram before and after treatment in the control group(P>0.05).The cardiopulmonary exercise test(metabolic equivalent)，ultra echocardiography(left ventricular short axis shortening rate，left ventricular ejection fraction，cardiac output）in the Yangxinshi group，the trimetazidine group and the Yangxinshi+ trimetazidine group were significantly higher than those at baseline and the control group at the same time.Ultrasonic cardiogram(left ventricular end-diastolic volume，left ventricular end-systolic volume）was significantly lower than those before treatment and control group at the same time(P<0.05).The cardiopulmonary exercise test(maximum systolic blood pressure，maximum heart rate and heart rate variability）in the Yangxinshi group and the Yangxinshi group+trimetazidine group were significantly lower than those before treatment and control group at the same time(P<0.05)，while there was no significant difference between the trimetazidine group and before treatment and the control group at the same time(P>0.05).There were no significant differences in cardiopulmonary exercise test，echo cardiograph，between the Yangxinshi group and the Yangxinshi+ trimetazidine group(P>0.05).There were no significant changes in resting systolic pressure，diastolic pressure，pulse pressure difference and resting heart rate among the 4 groups(P>0.05).Conclusion:After 6 months of observation，both Yangxinshi and Trimetazidine can significantly improve cardiac function，reversal myocardial remodeling and improve exercise tolerance in patients with chronic heart failure on the basis of optimizing drug treatment.They have no significant effects on resting blood pressure and heart rate，and Yangxinshi can reduce the maximum systolic pressure，maximum heart rate and heart rate change rate during exercise，as well as make patients more tolerant to exercise state.However，the combination of the 2 drugs has no additional benefits than any single drug.

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