Yang Ping, Guo Tao, Wang Wei, Peng Yun-Zhu, Wang Yu, Zhou Ping, Luo Zhi-Ling, Cai Hong-Yan, Zhao Ling, Yang Hong-Wen
Department of Cardiology, The First People's Hospital of Kunming, No. 504, Qingnian Road, Kunming, Yunnan, 650011, China.
Heart Vessels. 2013 May;28(3):284-91. doi: 10.1007/s00380-012-0244-7. Epub 2012 Mar 30.
Our aim was to evaluate the safety and effectiveness of extracorporeal cardiac shock wave therapy (CSWT) for the patients with coronary heart disease (CHD) using a randomized, double-blind, controlled clinical trial design. Twenty-five patients with CHD were enrolled in this study. Fourteen of the patients were randomized into the CSWT group and 11 into the control group. We applied the CSWT procedure to each patient by using nine shock treatments during 3 months, but the shock wave (SW) energy was only applied to the patients in the CSWT group and not to the patients in the control group. Technetium-99m sestamibi myocardial perfusion, fluorine-18 fluorodeoxyglucose myocardial metabolism single-photon emission computed tomography (SPECT), and two-dimensional echocardiography were performed to identify segments of myocardial ischemia, myocardial viability, and ejection fraction before and after CSWT. We also followed the patients to evaluate adverse effects. After CSWT, the New York Heart Association class, the Canadian Cardiovascular Society angina scale, nitroglycerin dosage, myocardial perfusion and myocardial metabolic imaging scores of dual-isotope SPECT in the CSWT group were reduced significantly (P = 0.019, 0.027, 0.039, 0.000, 0.001, respectively), and the Seattle Angina Questionnaire scale, 6-min walking test, and left ventricular ejection fraction were increased significantly (P = 0.021, 0.024, 0.016, respectively) compared with those before the SW treatment. All of the parameters in the control group did not change significantly after the treatment (all P > 0.05). No serious adverse effects of CSWT were observed. Cardiac shock wave therapy is a safe and effective treatment for CHD patients.
我们的目的是采用随机、双盲、对照临床试验设计，评估体外心脏冲击波疗法（CSWT）对冠心病（CHD）患者的安全性和有效性。本研究纳入了25例冠心病患者。其中14例患者被随机分为CSWT组，11例患者被分为对照组。我们在3个月内对每位患者进行9次冲击波治疗以实施CSWT程序，但仅对CSWT组患者施加冲击波（SW）能量，对照组患者不施加。在CSWT前后，进行锝-99m甲氧基异丁基异腈心肌灌注、氟-18氟脱氧葡萄糖心肌代谢单光子发射计算机断层扫描（SPECT）以及二维超声心动图检查，以确定心肌缺血节段、心肌存活性和射血分数。我们还对患者进行随访以评估不良反应。CSWT后，CSWT组的纽约心脏协会心功能分级、加拿大心血管学会心绞痛量表、硝酸甘油用量、双同位素SPECT的心肌灌注和心肌代谢成像评分均显著降低（P值分别为0.019、0.027、0.039、0.000、0.001），与SW治疗前相比，西雅图心绞痛问卷量表、6分钟步行试验及左心室射血分数均显著升高（P值分别为0.021、0.024、0.016）。治疗后对照组所有参数均无显著变化（所有P>0.05）。未观察到CSWT的严重不良反应。心脏冲击波疗法对冠心病患者是一种安全有效的治疗方法。
