体外心脏震波治疗冠心病患者的临床研究

A clinical study of extracorporeal cardiac shock wave treatment for patients with coronary heart disease

目的探讨体外心脏震波治疗系统(CSWT)治疗冠心病的安全性及疗效。方法将45例冠心病患者随机分为震波治疗组(予CSWT治疗,n=25)及对照组(不予震波治疗,n=20)。3个月为1个震波治疗周期,共行9次震波治疗。震波治疗组患者检测时间点为震波治疗前(0个月)、9次震波治疗结束时(3个月)、随访6个月时(6个月),对照组的相应检测时间点分别为入选时、随访3个月时、随访6个月时。两组患者分别在上述时间点行99 Tcm-甲氧基异丁基异腈(99 Tcm-MIBI)及18 F-氟脱氧葡萄糖(18F-FDG)双核素单光子发射型计算机断层成像(SPECT)心肌显像检查及微伏级T波电交替(MTWA)检查,评估加拿大心血管学会(CCS)心绞痛分级、纽约心脏协会(NYHA)心功能分级、西雅图心绞痛量表(SAQ)评分、6min步行距离(6MWT)、左心室射血分数(LVEF)。临床随访不少于6个月,比较两组患者的病死率、心肌再梗死率、再住院率、心肌灌注、心肌代谢及心功能的变化。结果 45例患者均完成随访。震波治疗组患者在3个月、6个月时的心肌灌注及代谢、NYHA心功能分级、CCS心绞痛分级、硝酸甘油用量、SAQ评分、6MWT、LVEF、MTWA均比0个月时明显改善(P<0.05),且上述指标均比同期对照组明显改善(P<0.05)。震波治疗组患者治疗后无死亡、无心肌再梗死发生。结论 CSWT是一项无创、安全、有效的新型血管再生疗法,可作为冠心病治疗的选择。

Objective To explore the safety and efficacy of extracorporeal cardiac shock wave therapy（CSWT） in coronary heart disease treatment.Methods 45 patients with coronary heart disease were randomly divided into shock wave therapy group（CSWT treatment,n=25） and control group（without CSWT treatment,n=20）.A shock wave treatment cycle contained 3 months and a total of 9 times shock wave therapy.The testing time points of patients in shock wave therapy group were before shock wave therapy（0 month）,the end of 9 times of shock wave therapy（3 months） and the end of 6 months follow-up（6 months）,and the corresponding testing time points of patients in control group were the time of enrollment,3 months follow-up and 6 months follow-up.Patients in both groups were subjected to cardiac double-nuclide single photon emission computed tomography（SPECT） examination using 99Tcm-methoxyisobutylisonitrile（99Tcm-MIBI）,18F-fluro-deoxyglucose（18F-FDG） and microvolt T wave alternans（MTWA） examination,and their Canadian Cardiovascular Society（CCS） angina grading,New York Heart Association（NYHA） cardiac function grading,Seattle angina questionnaire（SAQ） scoring,6 minute walk test（6MWT） and left ventricular ejection fraction（LVEF） were evaluated at the time points above.Duration of clinical follow-up was not less than 6 months.Changes of mortality,myocardial re-infarction rate,readmission rate,myocardial perfusion,metabolism and cardiac function of patients in the two groups were compared.Results All 45 patients completed follow-up.Myocardial perfusion and metabolism,NYHA cardiac function grading,CCS angina grading,nitroglycerin dose,SAQ scoring,6MWT,LVEF and MTWA of patients in shock wave therapy group at the time points of 3 months and 6 months were all significantly improved when compared to those at the time point of 0 month（P0.05） and those in control group at the same time points（P0.05）.No death and myocardial re-infarction was found in shock wave therapy group after treatment.Conclusion CSWT is a noninvasive,safe and effective new angiogenesis therapy which can be used as the choice for coronary heart disease treatment.