Neurosurgical Department, Pierre Wertheimer Hospital, Hospices Civils de Lyon, Lyon 1 University, Lyon, France.
Pain Center, "Pierre Wertheimer" Hospital, Hospices Civils de Lyon, Lyon, France.
Eur J Pain. 2019 Oct;23(9):1688-1700. doi: 10.1002/ejp.1445. Epub 2019 Aug 29.
Central neuropathic pain related to spinal cord injury is notoriously difficult to treat. So far most pharmacological and surgical options have shown but poor results. Recently ziconotide has been approved for use both neuropathic and non-neuropathic pain. In this cohort study, we assessed responder rate and long-term efficacy of intrathecal ziconotide in patients with pain related to spinal cord injury.
Patients presenting chronic neuropathic related to spinal cord lesions that was refractory to medical pain management were considered for inclusion. Those accepting were tested by lumbar puncture injection of ziconotide or continuous intrathecal infusion and if a significant decrease in pain scores (>40%) was noted they were implanted with a continuous infusion pump. They were then followed up for at least 1 year with constant assessment of the evolution of pain and side effects.
Out of the 20 patients tested 14 had a decrease in pain scores of more than 40% but only 11 (55%) were implanted with permanent pumps due to side effects and patient choice. These were followed up on average for 3.59 years (±1.94) and in eight patients an above threshold decrease in pain scores was maintained. Overall in patients that responded to the test baseline VAS was 7.91 and 4.31 at last follow-up with an average dose of 7.2 μg of ziconotide per day. Six patients (30%) did not respond to any test and in three patients side effects precluded pump implantation. No significant long-term effects of the molecule were noted.
This study shows response to intrathecal ziconotide test in 40% of the patients of a very specific population in whom other therapeutic options are not available. This data justifies the development further studies such as a long-term randomized controlled trial.
Intrathecal Ziconotide is a posible alternative for the treatment of pain in patients with spinal cord injury and below level neuropathic pain.
与脊髓损伤相关的中枢神经性疼痛非常难以治疗。到目前为止，大多数药物和手术治疗方法的效果都不理想。最近，已批准使用齐考诺肽治疗神经性和非神经性疼痛。在这项队列研究中，我们评估了鞘内注射齐考诺肽治疗脊髓损伤相关疼痛患者的应答率和长期疗效。
纳入患有慢性神经性脊髓损伤相关疼痛且对药物疼痛管理无效的患者。接受鞘内注射齐考诺肽或连续鞘内输注的患者进行测试，如果疼痛评分显著下降（>40%），则植入持续输注泵。然后对患者进行至少 1 年的随访，持续评估疼痛和不良反应的演变。
在接受测试的 20 名患者中，14 名患者的疼痛评分下降超过 40%，但由于不良反应和患者选择，只有 11 名（55%）植入了永久性泵。这些患者平均随访 3.59 年（±1.94 年），8 名患者疼痛评分维持在阈值以上。总体而言，对测试有反应的患者基线 VAS 为 7.91，最后一次随访时为 4.31，平均每天使用 7.2μg 的齐考诺肽。6 名患者（30%）对任何测试均无反应，3 名患者因不良反应而无法植入泵。未观察到该分子的长期显著影响。
本研究显示，在其他治疗选择不可用的非常特定人群中，有 40%的患者对鞘内注射齐考诺肽测试有反应。这些数据支持进一步开展长期随机对照试验等研究。
鞘内注射齐考诺肽可能是脊髓损伤和低于损伤水平的神经性疼痛患者的治疗选择。
