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心脏冲击波治疗慢性难治性心绞痛。一项前瞻性安慰剂对照随机试验。

Cardiac shock wave therapy for chronic refractory angina pectoris. A prospective placebo-controlled randomized trial.

机构信息

Division of Cardiology, Swiss Cardiovascular Center, Bern University Hospital, and University of Bern, Switzerland.

出版信息

Cardiovasc Ther. 2013 Jun;31(3):e1-6. doi: 10.1111/j.1755-5922.2012.00313.x.

DOI:10.1111/j.1755-5922.2012.00313.x
PMID:22953794
Abstract

BACKGROUND

Cardiac shock wave therapy (CSWT) delivered to the myocardium increases capillary density and regional myocardial blood flow in animal experiments. In addition, nonenzymatic nitric oxide production and the upregulation of vascular growth factor's mRNA by CSWT have been described. The aim of the study was therefore to test its potential to relieve symptoms in patients with chronic stable angina pectoris.

METHODS

Twenty-one patients (mean age 68.2 ± 8.3 years, 19 males) with chronic refractory angina pectoris and evidence of inducible myocardial ischemia during MIBI-SPECT imaging, were randomized into a treatment (n = 11) and a placebo arm (n = 10). The region of exercise-induced ischemia was treated with echocardiographic guidance during nine sessions over a period of 3 months. One session of CSWT consisted of 200 shots/spot (9--12 spots/session) with an energy intensity of 0.09 mJ/mm(2) . In the control group acoustic simulation was performed without energy application. Medication was kept unchanged during the whole treatment period.

RESULTS

In the treatment group, symptoms improved in 9/11 patients, and the ischemic threshold, determined by cardiopulmonary exercise stress testing, increased from 80 ± 28 to 95 ± 28 W (P= 0.036). In the placebo arm, only 2/10 patients reported an improvement and the ischemic threshold remained unchanged (98 ± 23 to 107 ± 23 W; P= 0.141). The items "physical functioning" (P= 0.043), "general health perception" (P= 0.046), and "vitality" (P= 0.035) of the SF-36 questionnaire significantly improved in the treatment arm, whereas in the placebo arm, no significant change was noted. Neither arrhythmias, troponin rise nor complications were observed during treatment.

CONCLUSIONS

This placebo controlled trial shows a significant improvement in symptoms, quality of life parameters and ischemic threshold during exercise in patients with chronic refractory angina pectoris treated with CSWT. Thus, CSWT represents a new option for the treatment of patients with refractory AP.

摘要

背景

心脏冲击波治疗(CSWT)作用于心肌,可增加毛细血管密度和局部心肌血流。此外,CSWT 可促进非酶促一氧化氮产生和血管生长因子 mRNA 的上调。因此,本研究旨在检测 CSWT 缓解慢性稳定性心绞痛患者症状的潜力。

方法

21 例(平均年龄 68.2 ± 8.3 岁,男性 19 例)慢性难治性心绞痛患者,行 MIBI-SPECT 成像显示有可诱导心肌缺血,随机分为治疗组(n = 11)和安慰剂组(n = 10)。在 3 个月的时间内,共进行 9 次超声心动图引导下的心脏冲击波治疗,每次治疗 1 个区域。每次心脏冲击波治疗包含 200 个冲击/点(9-12 个点/次),能量强度为 0.09 mJ/mm2。在对照组,进行声刺激但不给予能量。整个治疗期间,药物治疗保持不变。

结果

治疗组 11 例患者中有 9 例症状改善,心肺运动压力测试确定的缺血阈值从 80 ± 28 W 增加至 95 ± 28 W(P = 0.036)。在安慰剂组中,仅 10 例患者中的 2 例报告症状改善,缺血阈值保持不变(98 ± 23 W 至 107 ± 23 W;P = 0.141)。SF-36 问卷的“身体机能”(P = 0.043)、“总体健康感觉”(P = 0.046)和“活力”(P = 0.035)项目在治疗组中显著改善,而在安慰剂组中,没有显著变化。在治疗过程中,未观察到心律失常、肌钙蛋白升高或并发症。

结论

本安慰剂对照试验显示,慢性难治性心绞痛患者接受 CSWT 治疗后,症状、生活质量参数和运动时缺血阈值显著改善。因此,CSWT 为治疗难治性心绞痛患者提供了一种新的选择。

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