Istituto di Cardiologia, Università Cattolica del Sacro Cuore, Roma, Italy Dipartimento di Cardiologia, Ospedale Le Molinette, Torino, Italy Divisione di Cardiologia, Ospedale San Filippo Neri, Roma, Italy Divisione di Cardiologia, Ospedale San Matteo, Pavia, Italy Divisione di Cardiologia and Anestesia, Ospedale Buccheri la Ferla Fatebenefratelli, Palermo, Italy Divisione di Cardiologia, Ospedale Umberto I, Mestre, Italy Dipartimento di Anestesia, Ospedale Le Molinette, Torino, Italy Divisione di Anestesia, Ospedale San Matteo, Pavia, Italy Divisione di Anestesia, Ospedale Umberto I, Mestre, Italy Istituto di Neurochirurgia, Università Cattolica del Sacro Cuore, Roma, Italy.
Pain. 2011 Jan;152(1):45-52. doi: 10.1016/j.pain.2010.08.044. Epub 2010 Nov 16.
Spinal cord stimulation (SCS) is believed to be effective in treating refractory angina. The need for SCS-related chest paresthesia, however, has hitherto made impossible placebo-controlled trials. Subliminal (non paresthesic) SCS, however, might be also effective on anginal pain. In this trial we compared subliminal SCS with paresthesic SCS and with sham SCS. Twenty-five refractory angina patients, who had never received SCS before, underwent SCS device implantation and were randomized to three groups: paresthesic SCS (group PS; n=10), subliminal SCS (group SS; n=7) or "sham" SCS (group NS; n=8). After 1month group NS patients were randomized to either group PS or SS. After 1month, changes in angina episodes (p=0.016), nitroglycerin use (p=0.015), angina class (p=0.02), quality of life score (p=0.05), and items 2 (p=0.008) and 3 (p=0.009) of Seattle angina questionnaire differed significantly among groups. Group PS showed significant improvement in outcomes compared to group NS, whereas there were no significant differences between groups SS and NS; furthermore, only nitroglycerin use differed significantly between groups PS and SS. At 3months, a significant difference between groups PS and SS was observed in angina attacks (p=0.002), but not in other variables. Thus, in this study, paresthesic, but not subliminal SCS was superior to sham SCS in improving clinical status in refractory angina patients. The lack of significant differences between PS and SS groups in this small study suggests that a possible role for subliminal SCS in individual patients deserves to be assessed in larger trials with appropriate statistical power.
脊髓刺激（SCS）被认为对治疗难治性心绞痛有效。然而，SCS 相关的胸部感觉异常的需求使得安慰剂对照试验成为不可能。然而，阈下（非感觉异常）SCS 也可能对心绞痛疼痛有效。在这项试验中，我们将阈下 SCS 与感觉异常 SCS 以及假 SCS 进行了比较。25 名从未接受过 SCS 治疗的难治性心绞痛患者接受了 SCS 设备植入，并被随机分为三组：感觉异常 SCS 组（PS 组，n=10）、阈下 SCS 组（SS 组，n=7）或假 SCS 组（NS 组，n=8）。1 个月后，NS 组患者被随机分为 PS 组或 SS 组。1 个月后，心绞痛发作次数（p=0.016）、硝酸甘油使用（p=0.015）、心绞痛分级（p=0.02）、生活质量评分（p=0.05）和西雅图心绞痛问卷项目 2（p=0.008）和 3（p=0.009）在三组之间差异有统计学意义。PS 组与 NS 组相比，结果有显著改善，而 SS 组与 NS 组之间无显著差异；此外，只有硝酸甘油的使用在 PS 组和 SS 组之间有显著差异。3 个月时，PS 组和 SS 组在心绞痛发作（p=0.002）方面存在显著差异，但其他变量无差异。因此，在这项研究中，感觉异常 SCS 而非阈下 SCS 在改善难治性心绞痛患者的临床状况方面优于假 SCS。这项小规模研究中 PS 组和 SS 组之间无显著差异表明，阈下 SCS 在个别患者中的可能作用值得在具有适当统计能力的更大规模试验中进行评估。
