【原】背根神经节电刺激治疗慢性顽固性疼痛的前瞻性长期随访研究（一）

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本次文献选自Eldabe S, Copley S, Gulve A,  et al. A prospective long-term follow-up of dorsal root ganglion stimulation for the management of chronic intractable pain. Pain. 2022,163(4):702-710. 本次学习由王珺楠副主任医师主讲。

Abstract

Initial clinical studies have shown that the stimulation of the dorsal root ganglion (DRG) can significantly reduce chronic intractable pain. However, clinical data on long-term results and complications of these systems are limited. The aim of this prospective study is to report on a single center long-term follow-up of DRG stimulation for intractable chronic pain. Participants were implanted with DRG stimulation devices between 2013 and 2015 with an observation period of 24 months. Patients were contacted again in 2020 for a final follow-up (ie, between 5 and 7 years postimplantation). Forty-two participants were recruited, of whom 32 received the fully implantable pulse generator (IPG). At the final follow-up, 50% (16/32) of participants were still using DRG stimulation. Two participants still had the original IPG and 14 had received a replacement IPG. Pain scores were significantly reduced at 24 months, mean difference 1.7 (95% confidence interval: 0.2-3.3, P = 0.03), and at the last follow-up, mean difference 2.1 (95% confidence interval: 0.3-4, P = 0.03). Significant improvements were observed for health-related quality of life. The findings were generally robust to imputation methods of missing data. Implantable pulse generators of 8 patients were explanted because of dissatisfaction with pain relief. In conclusion, DRG stimulation can provide effective pain relief and improved quality of life in patients suffering with neuropathic pain, although this study had a revision rate of 42% within the first 24 months, and 56% of IPGs that were replaced because of battery depletion had a shorter than expected battery life.

Keywords: Chronic pain, Neurostimulation, Complex regional pain syndrome, Causalgia, Dorsal root ganglion stimulation, Back pain, Leg pain, Neuropathic pain

摘要

初步临床研究已表明背根神经节(DRG)电刺激可以显著减轻慢性顽固性疼痛。然而，关于电刺激系统的长期结果和并发症的临床数据是有限的。本前瞻性研究的目的是报道DRG电刺激治疗顽固性慢性疼痛的单中心长期随访结果。参与者为在2013年至2015年期间植入DRG电刺激装置的患者，观察时间为24个月。2020年再次联系患者进行最后一次随访（即术后5-7年）。研究招募了42名参与者，其中32人接受了完全可植入式脉冲发生器(IPG)。在最后一次随访中，50%（16/32）的参与者仍然在使用DRG电刺激。两名参与者仍然拥有原来的IPG，14名参与者更换了IPG。24个月时，疼痛评分显著降低，平均值为1.7(95%置信区间：0.2-3.3，P=0.03)；最后一次随访中，平均值为2.1(95%可信区间：0.3-4，P= 0.03)。健康相关生活质量得到显著改善。研究结果对缺失数据的归因方法一般都是稳健的。8例患者因对疼痛缓解不满而移除IPG。总之，DRG电刺激可有效患者神经病理性疼痛患者的疼痛，并改善生活质量，尽管本研究中24个月时有42%的返修率，56%IPG由于电池寿命短于预期产生的电池耗尽，发生更换IPG。

关键词：慢性疼痛、神经刺激、复杂区域疼痛综合征、灼痛、背根神经节电刺激、背痛、腿痛、神经病理性疼痛。

1.Introduction

Chronic neuropathic pain is a disabling and severe pain condition. Conventional treatments such as analgesics, nerve blocks, and physical therapy provide limited relief with some resulting in unacceptable side effects.

1.引文

慢性神经病理性疼痛是一种致残的且严重的疼痛状况。传统的治疗，如镇痛药、神经阻滞和物理疗法治疗效果有限，常导致不可接受的副作用。

Spinal cord stimulation (SCS) and DRG stimulation (DRGS) have reported effectiveness in the treatment of neuropathic pain. Although conventional SCS often provides significant pain relief from whole limb pain, focal pains limited to discreet areas such as the hands, feet, and groin often prove difficult to target. The higher levels of stimulation currents needed to provide sufficient coverage to the focal pain areas often result in stimulation of larger areas that were otherwise pain free. Even with precise SCS lead placement, the natural variation in the distance between the stimulating electrode and the neural target because of changes in posture or coughing results in clinically significant changes in levels of stimulation, requiring the patient to adjust the stimulation amplitude to minimise overstimulation or understimulation which may in turn result in reduced levels of analgesia.

脊髓电刺激(SCS)和背根节电刺激(DRGS)在神经病理性疼痛的治疗中已报道有效。虽然传统的SCS通常能显著缓解整个肢体的疼痛，但局限于手、脚、腹股沟等区域的局灶性疼痛往往难以定位。覆盖局灶性疼痛区域需要更大的刺激电流，往往导致更广泛的无痛区域的刺激。即使SCS电极位置放置精确，由于姿势变化或咳嗽等原因也会引起刺激电极和目标神经之间的距离发生自然变化，导致刺激水平的临床显著变化，需要患者调整刺激幅度，以减少过度刺激或刺激不足，这可能会导致镇痛水平的降低。