急性心肌梗死直接经皮冠状动脉介入术后应用益气养阴活血法治疗的效果：随机对照试验

背景：急性心肌梗死（acute myocardial infarction,AMI）再灌注治疗后,仍有许多患者存在心肌组织的无复流现象。如何改善AMI血运重建后心肌微循环的血流灌注,目前尚无明确有效的中、西医治疗方案。目的：探讨益气养阴活血法对AMI直接经皮冠状动脉介入术（percutaneous coronary intervention,PCI）后的临床疗效,并探讨其对梗死部位心肌组织微循环血流的作用。设计、场所、受试者和干预措施：按照随机、对照、双盲的原则,选择北京大学人民医院2005年1月至2006年3月首次诊断为ST段抬高性AMI并接受急诊直接PCI治疗成功（KillipⅠ～Ⅱ）,同时符合中医气阴两虚和心血瘀阻证的患者35例,分为两组。治疗组在西药常规治疗基础上加用益气养阴、活血化瘀的西洋参和丹参制剂,对照组在西药常规治疗基础上加用安慰剂。疗程为3个月。主要结局指标：观察两组患者治疗前后中医证候积分,静息状态及20μg/（kg·min）多巴酚丁胺负荷状态下的左心室射血分数、室壁运动计分指数、正常心肌百分比,观察反映微循环血流灌注速度的心肌声学造影参数k值。结果：治疗3个月后,治疗组中医证候积分显效率、有效率及总有效率均高于对照组,差异有统计学意义（χ^2=4.118,P=0.042）;多巴酚丁胺负荷状态下,治疗组左心室射血分数较治疗前显著增加（t=2.345,P=0.032）,较对照组亦显著增加（t=2.130,P=0.041）。治疗3个月后,不同状态下治疗组k值增加的室壁节段数均较对照组多,但差异无统计学意义。结论：中医益气养阴活血法能改善AMI患者直接PCI术后的临床症状,对心肌微循环血流灌注与心肌收缩能力的改善有一定作用。

Therapy for replenishing qi, nourishing yin and promoting blood circu-lation in patients with acute myocardial infarction undergoing percu-taneous coronary intervention: a randomized controlled trial

Background： No-reflow phenomenon after reperfusion treatment of acute myocardial infarction （AMI） is becoming more recognized today. The effective treatment for no-reflow has not been reported. Objective： To observe the effects of traditional Chinese medicine （TCM） therapy for replenishing qi, nourishing yin, and promoting blood circulation on AMI patients undergoing percutaneous coronary intervention （PCI）.
Design, setting, participants and interventions： This study was conducted from January 2005 to March 2006 using a double-blinded, randomized method. Thirty-five AMI patients （Killip Ⅰ - Ⅲ） were first diagnosed as ST segment elevation AMI and obtained primary PCI. They were recruited from People＇s Hospital, Peking University. All patients＇ symptoms accorded with qi-yin deficiency syndrome and blood stasis syndrome. They were randomly and double blindly divided into control group （18 cases） and treatment group （17 cases）. The patients in the control group received Western medicine treatment, and the patients in the treatment group were treated with Western medicine plus American ginseng and Salviae miltiorrhizae PreParations. They were all treated for 3 months.
Main outcome measures： Before and after 3-month treatment, the TCM symptoms were observed and scored. At the state of baseline and dobutamine stress, left ventricular ejection fraction （LVEF）, wall motion score （WMS）, WMS index and normal cardiac muscle percentage （NCMP）, and the myocardial contrast echocardiography index k, which reflects myocardium microcirculation perfusion, were detected.
Results： After 3-month treatment, the TCM symptoms in the treatment group were improved as compared with the control group （χ^2 =4. 118, P=0. 042）. At the state of dobutamine stress, LVEF in the treatment group after treatment was higher than those in the control group （t=2. 130, P=0. 041） and before treatment （t= 2. 345, P=0.032）. Although the number of the segments with increased k value was more than that in the control group, there was no significant difference.
Conclusion： TCM therapy for replenishing qi, nourishing yin and promoting blood circulation can improve the clinical symptoms and quality of life of the AMI patients undergoing PCI, and is beneficial to myocardium microcirculation. Thus, it may be an alternative cardioprotective treatment strategy for successful myocardial microcirculation in AMI patients after reperfusion.