Thoracic spinal cord stimulation improves functional status and relieves symptoms in patients with refractory angina pectoris:: the first placebo-controlled randomised study
Thoracic spinal cord stimulation improves functional status and relieves symptoms in patients with refractory angina pectoris:: the first placebo-controlled randomised study
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DOI：
10.1136/hrt.2006.100784
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发表时间：
2007-05-01
期刊：
影响因子：
5.7
通讯作者：
Theres, Heinz
中科院分区：
文献类型：
--
作者：
Eddicks, Stephan;Maier-Hauff, Klaus;Theres, Heinz
背景：脊髓刺激（SCS）是难治性心绞痛的替代治疗选择。对照试验表明症状缓解和功能状态改善。由于患者在活动性 SCS 期间会出现胸骨后刺痛，因此无法对患者进行盲目治疗或安慰剂对照。 目的： 在安慰剂对照研究中检查阈下 SCS 对难治性心绞痛患者的治疗效果。 方法： 纳入了 12 名已接受 SCS 治疗难治性心绞痛的治疗反应者。患者被随机分为四个连续治疗组，每个治疗组持续 4 周，具有不同的刺激时间和输出参数：362 小时/天（A 期）和 24 小时/天，常规输出（B 期）； 362 小时/天，亚阈值输出（C 阶段）；每天 24 小时，输出 0.1 V，作为对照（D 相）。每 4 周结束时评估功能状态、生活质量、加拿大心血管学会分类和硝酸盐使用情况。结果：在 D 期，与 A 期和 C 期相比，患者的步行距离显着减少。与 A-C 期相比，D 期加拿大心血管学会分类恶化。 D 期心绞痛发作频率和视觉模拟量表明显差于 A-C 期。在三名患者中，由于无法忍受的心绞痛发作，有必要提前终止 D 阶段。结论：在这第一个对难治性心绞痛患者应用 SCS 的安慰剂对照试验中，与低输出（安慰剂）阶段相比，在常规或阈值下刺激阶段显示功能状态和症状的改善。
Background: Spinal cord stimulation (SCS) is an alternative treatment option for refractory angina. Controlled trials demonstrate symptom relief and improvement in functional status. Since patients experience retrosternal prickling during active SCS, there is no option for blinding patients to active treatment or for placebo control.Objective: To examine the therapeutic effects of subthreshold SCS in patients with refractory angina in a placebo-controlled study.Methods: 12 responders to treatment who had already been treated with SCS for refractory angina were enrolled. Patients were randomised into four consecutive treatment arms, each for 4 weeks, with various stimulation timing and output parameters: 362 h/day ( phase A) and 24 h/day with conventional output ( phase B); 362 h/day with a subthreshold output ( phase C); and 24 h/day with 0.1 V output, which served as control ( phase D). Functional status, quality of life, Canadian Cardiovascular Society classification and nitrate usage were assessed at the end of each 4-week period.Results: In phase D, patients showed a significant reduction in walking distance compared with phases A and C. Canadian Cardiovascular Society classification worsened in phase D compared with phases A-C. Frequency of angina attacks and the visual analogue scale were significantly worse in phase D than in phases A-C. In three patients, it was necessary to prematurely terminate phase D owing to intolerable angina attacks.Conclusions: In this first placebo-controlled trial to apply SCS in patients with refractory angina, improvement in functional status and symptoms was revealed in phases with conventional or subthreshold stimulation, in comparison to a low-output ( placebo) phase.