体外心脏震波治疗冠心病的有效性研究

A study on the effectiveness of extracorporeal cardiac shock wave therapy for treatment of coronary artery disease

目的探讨体外心脏震波治疗(CSWT)冠心病(CAD)的可行性、安全性及疗效。方法 连续选取2008年10月至2010年6月在昆明医学院第一附属医院心内科就诊的CAD陈旧性心肌梗死(OMI)患者25例,男18例,女7例,平均年龄65岁,采用随机双盲安慰剂对照法,将患者分为试验组14例(予震波能量治疗),安慰剂对照组11例(不予震波能量治疗),3个月为1个治疗周期,共9次震波治疗。两组治疗前后均行99mTc-甲氧基异丁基异腈(MIBI)/18氟-脱氧葡萄糖(FDG)双核素单光子发射计算机体层摄影(SPECT)心肌显像检查、加拿大心血管学会(CCS)心绞痛分级、纽约心功能分级(NYHA)、西雅图心绞痛量表(SAQ)、6 min步行距离(6MWT)、左室射血分数(LVEF)等检查,临床随访不少于6个月,比较组间病死率、再住院率、震波治疗前后心肌灌注及代谢、心绞痛症状、心功能及运动耐量等的变化。结果 25例患者均依研究方案完成治疗,无心绞痛加剧、心肌损伤、出血、栓塞、恶性心律失常等并发症。平均(8.40±1.84)个月的随访期内,试验组1例死亡,对照组无死亡(P>0.05)。7例因心绞痛频发再住院,其中试验组2例,对照组5例(P>0.05)。试验组震波治疗后的NYHA、CCS心绞痛分级、硝酸甘油用量较治疗前减低(P<0.05),而SAQ评分、6MWT较治疗前增高(P<0.05)。试验组震波治疗后心肌灌注、心肌代谢及LVEF均较治疗前有改善(P<0.05)。对照组震波治疗前后以上指标均改变不明显(P>0.05)。结论 CSWT是CAD治疗的最新选择,是一项无创、安全、有效的新型血管再生疗法,可缓解患者心绞痛、改善心功能、提高运动耐量。

Objective To evaluate the feasibility,security and efficiency of extracorporeal cardiac shock wave therapy（CSWT）for treatment of coronary artery disease.Methods A total of 25 patients with old myocardial infarction（OMI without thrombolysis or PCI or CABG） were included in this study（mean age 65 years old）.According to random digits table,using the method of Double-Blind,patients were divide into the experimental group（14 patients were treated with shock wave,200 shots/spot at 0.09 mJ/mm2 for 9 spots,amount to 9 times within 3 month） and the placebo control group（11 patients were treated with the same procedures but without shock wave）.Before and after treament,all patients received the examinations include the 99mTc-MIBI myocardial perfusion SPECT and the 18F-FDG myocardial metabolism SPECT,Canadian Cardiovascular Society（CCS） class sores,NYHA,Seattle Angina Questionnaire（SAQ）,6-min walk test（6MWT）,Left ventricular ejection fraction（LVEF）,nitroglycerin dosage and so on.The changes of the mortality,rehospitalization,myocardial perfusion and myocardial metabolism between before and after shock wave therapy were detected,in placebo control group and experimental group during follow up（8.40±1.84） months.Results Twenty-five patients completed the therapy based on the method of Double-Blind,didn′t occur procedural complications or adverse effects.There was no dead patient in the placebo control group,but 1 patient died in the experimental group（P0.05）.7 patients suffered from rehospitalization,2 in the experimental group and 5 in the placebo control group（P0.05）.After treatment of CSWT,the NYHA,CCS class sores and the dose of nitroglycerin were less than that of pretherapy in the experimental group（P0.05）,but SAQ,6MWT,myocardial perfusion,myocardial metabolism,and LVEF were more than that of pretherapy（P0.05）.Whereas,all the parameters of the placebo control group didn′t have significant change（P0.05）.Conclusion Extracorporeal cardiac shock wave therapy is safe,non-invasive and effective for CAD in ameliorating anginal symptoms,heart function and exercise tolerance which was associated by a substantial reduction of ischemic myocardium.