芪参益气滴丸对急性心肌梗死再灌注后心功能及生存质量的影响--一项多中心随机双盲安慰剂对照试验

Qishenyiqi Dripping pills improves quality of life and cardiac function of patients with acute myocardial infarction after undergoing percutaneous coronary intervention:a multicenter,randomized double-blind and placebo-controlled trial

目的评价芪参益气滴丸对急性ST段抬高型心肌梗死(STEMI)患者经皮冠脉介入治疗(PCI)后在心功能、主要心血管不良事件(MACE)、生活质量等的影响。方法采用多中心、双盲、安慰剂、随机对照前瞻性临床研究方法。选择广州中医药大学第二附属医院、上海中医药大学附属曙光医院、徐州市中心医院、北京中医药大学东方医院、新疆维吾尔自治区中医院、柳州市中医院、江门五邑市中医院、广州市红十字会医院共8家医院2013年8月至2015年3月收治的216例接受PCI的急性心肌梗死(AMI)患者作为研究对象。将患者以分中心为分层因素区组的随机分配方法分为中药治疗组(110例)及对照组(106例)。两组均接受西医常规治疗,对照组在此基础上给予安慰剂口服,中药治疗组给予芪参益气滴丸。两组均每次0.5 g,每日3次,疗程为6个月。通过比较两组STEMI患者治疗6个月后MACE事件、美国纽约心脏病协会(NYHA)心功能分级、心肌梗死多维度量表(MIDAS)评分、不良反应发生情况的差异,评价患者心功能及生存质量的情况。结果治疗前两组MIDAS 7个方面(安全性、躯体活动、情绪反应、依赖性、饮食、担心用药、不良反应)评分比较差异均无统计学意义(均P>0.05),治疗后中药治疗组躯体活动及不良反应评分均明显低于对照组〔躯体活动评分(分):9.26±8.10比10.31±6.71,不良反应评分(分):0.0(0.0,1.0)比0.0(0.0,1.7),均P<0.05〕;两组治疗后安全性、情绪反应、依赖性、饮食、担心用药方面评分和基础状况时NYHA心功能分级比较差异均无统计学意义(均P>0.05)。中药治疗组治疗后NYHA 1级患者比例较对照组明显增加〔73.6%(81/110)比58.5%(62/106),P<0.05〕,NYHA 2级和3级患者比例较对照组明显减少〔25.5%(28/110)比37.7%(40/106),0.9%(1/110)比3.8%(4/106),均P<0.05〕,MACE事件发生率较对照组降低〔10.9%(12/110)比16.0%(17/106)〕,但差异无统计学意义(P>0.05)。结论芪参益气滴丸治疗PCI后STEMI可促进患者心功能恢复,并提高患者的生存质量。

Objective To evaluate the effects of Qishenyiqi Dripping pill(QSYQ)on the cardiac function,major adverse cardiovascular event(MACE)and quality of life in patients with acute ST segment elevation myocardial infarction(STEMI)after percutaneous coronary intervention(PCI).Methods A multicenter,double-blind,placebo,randomized controlled prospective clinical study was conducted.A total of 216 STEMI patients after PCI admitted to the 8 hospitals,as the Second Affiliated Hospital of Guangzhou University of Chinese Medicine(CM),Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine(TCM),Xuzhou Center Hospital,Dongfang Hospital Beijing University of CM,Xinjiang Uyghur Autonomous Region Hospital of TCM,Liuzhou TCM Hospital,Jiangmen Wuyi TCM Hospital,Guangzhou Red Cross Hospital,from August 2013 to March 2015 were enrolled in the study as the research objects.All included patients were randomly assigned to a TCM treatment group(n=110)and a control group(n=106)according to the method of sub-center as stratified factor block group.Both groups received basic conventional western medicine treatment.On this basis,patients in the control group would take identical placebo,while the TCM treatment group would receive QSYQ,usage:0.5 g each time,3 times a day,with the course of treatment for 6 months.The cardiac function and quality of life of STEMI patients were evaluated by comparing the differences of MACE scores,New York Heart Association(NYHA)cardiac function classification,myocardial infarction multidimensional assessment scale(MIDAS)scores and incidence of adverse reaction between the two groups after 6 months of treatment.Results There were no statistically significant differences in 7 dimensions(insecurity,physical activity,emotional reaction,dependency,diet,concerns over medication and adverse reaction)of MIDAS between two groups before treatment(all P>0.05).Compared with the control group,the patients in TCM treatment group were found to have a statistically significant lower score in physical activity(9.26±8.10 vs.10.31±6.71,P<0.05)and incidence of adverse reaction[0.0(0.0,1.0)vs.0.0(0.0,1.7)]in dimensions of MIDAS after treatment(both P<0.05).However,no statistical significant differences were found between the two groups after treatment in insecurity,emotional reaction,dependency,diet and concerns over medication dimensions and NYHA cardiac function classification in baseline between the two groups(all P>0.05).After treatment,the proportion of NYHA Grade 1 in TCM treatment group was statistically higher than that in control group[73.6%(81/110)vs.58.5%(62/106),P<0.05].And the proportion of NYHA Grade 2 and Grade 3 in TCM treatment group were statistically lower than that in control group[25.5%(28/110)vs.37.7%(40/106),0.9%(1/110)vs.3.8%(4/106),both P<0.05].The incidence of MACE events in the TCM treatment group was lower than that in the control group[10.9%(12/110)vs.16.0%(17/106)],but the difference was not statistically significant(P>0.05).Conclusion QSYQ treatment can improve quality of life and cardiac function of STEMI patients after PCI.