日本脊髓刺激治疗难治性腿痛患者的临床疗效。

Clinical outcomes of spinal cord stimulation in patients with intractable leg pain in Japan.

机构信息

Department of Cardiovascular Medicine, Yao Municipal Hospital, Yao, Osaka, Japan.

出版信息

Pain Pract. 2024 Jul;24(6):826-831. doi: 10.1111/papr.13363. Epub 2024 Mar 8.

DOI:10.1111/papr.13363

PMID:38459710

Abstract

BACKGROUND

Neuromodulation through spinal cord stimulation (SCS) is a therapeutic option for relieving leg pain and improving the chances of limb salvage in patients with intractable chronic limb-threatening ischemia (CLTI); however, there is no consensus on its indications.

OBJECTIVE

The aim of this study was to assess the clinical outcomes of SCS in patients with intractable leg pain caused by various diseases treated in the department of cardiovascular medicine in Japan.

METHODS

This was a retrospective study of patients who underwent SCS for pain management. Patients were considered eligible for the therapy if they met the following criteria: (1) intractable leg pain (numerical rating scale [NRS] score of 10), (2) no revascularization option, and (3) no septicemia.

RESULTS

Twenty patients (mean age: 77 years; men/women: 11/9) were included in this study. The NRS score of the patients significantly reduced from 10 ± 0 before procedure to 4 ± 3 at discharge (p < 0.001). The clinical response rate of the entire cohort was 65% (13/20) at 17 ± 14 months after implantation; however, patients with intractable CLTI showed a low response rate (45%), whereas those with subacute limb ischemia showed a high response rate (100%). A multivariable regression analysis showed that hemoglobin level was significantly associated with treatment response, even after adjusting for age and sex (p = 0.026). The area under the receiver operating characteristic curve for the correlation between hemoglobin level (cutoff, 11.4 g/dL) and clinical response to SCS was 0.824 (0.619-1).

CONCLUSIONS

SCS can reduce clinical symptoms in majority of patients with intractable leg pain. Although implantation of an SCS device has been shown to improve microvascular perfusion insufficiency, the correlation between hemoglobin level and the clinical effect of SCS indicates that a preserved microcirculatory vascular bed is essential for the therapy to be effective.

摘要

背景

脊髓刺激（SCS）神经调节是缓解难治性慢性肢体威胁性缺血（CLTI）患者腿部疼痛和提高肢体保肢机会的治疗选择；然而，其适应证尚无共识。

目的

本研究旨在评估日本心血管医学科治疗的各种疾病导致的难治性腿部疼痛患者接受 SCS 治疗的临床结局。

方法

这是一项接受 SCS 进行疼痛管理的患者回顾性研究。如果患者符合以下标准，则被认为有资格接受该治疗：（1）难治性腿部疼痛（数字评分量表 [NRS] 评分 10），（2）无血运重建选择，以及（3）无败血症。

结果

本研究纳入 20 例患者（平均年龄：77 岁；男/女：11/9）。患者的 NRS 评分从术前的 10±0 显著降低至出院时的 4±3（p<0.001）。整个队列在植入后 17±14 个月的临床反应率为 65%（13/20）；然而，难治性 CLTI 患者的反应率较低（45%），而亚急性肢体缺血患者的反应率较高（100%）。多变量回归分析表明，即使在校正年龄和性别后，血红蛋白水平与治疗反应显著相关（p=0.026）。血红蛋白水平（临界值，11.4 g/dL）与 SCS 临床反应相关性的受试者工作特征曲线下面积为 0.824（0.619-1）。