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一项开放性标签研究:比较纳布啡和加巴喷丁作为辅助治疗或单药治疗外周神经病变患者神经病理性疼痛的疗效。

An open-label comparison of nabilone and gabapentin as adjuvant therapy or monotherapy in the management of neuropathic pain in patients with peripheral neuropathy.

机构信息

Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.

出版信息

Pain Pract. 2011 Jul-Aug;11(4):353-68. doi: 10.1111/j.1533-2500.2010.00427.x. Epub 2010 Nov 18.

Abstract

Neuropathic pain (NeP) is prevalent in patients with peripheral neuropathy (PN), regardless of etiology. We sought to compare the efficacy of the cannabinoid nabilone as either monotherapy or adjuvant therapy with a first-line medication for NeP, gabapentin, in a patient population with PN-NeP. Patients diagnosed with PN-NeP were permitted to initiate monotherapy (nabilone or gabapentin) or add one of these two medications (adjuvant therapy) to their existing NeP treatment regimen in a non-randomized open-label nature. Baseline data collected included a primary outcome (visual analog scores [VAS] of pain) and secondary outcomes (quality of life [EuroQol 5 Domains and Short-Form 36] assessments and assessments of sleep [Medical Outcomes Sleep Study Scale {MOSSS}], anxiety and depression [Hospital Anxiety and Depression Scale], and pain [Brief Pain Inventory]). Reassessment and modulation of dosing and/or medications occurred at 3- and 6-month intervals. Medication adverse effects and drug efficacy, as well as questionnaires, were assessed at 6 months. Matched analysis of variance testing was performed to compare 3- and 6-month scores with baseline, as well as to compare therapies at equal time points. Significant improvements in pain VAS were seen in all treatment groups at 6 months. Numerous sleep parameters within MOSSS, Brief Pain Inventory, and Short-Form 36 improved in patients receiving nabilone or gabapentin either as monotherapy or adjuvant treatment. Hospital Anxiety and Depression Scale-A scores were significantly improved in all treatment groups. Sleep adequacy and the sleep problems index within the MOSSS improved in nabilone monotherapy patients in particular. The benefits of monotherapy or adjuvant therapy with nabilone appear comparable to gabapentin for management of NeP. We advocate for head-to-head randomized, double-blind studies for current therapies for NeP in order to determine potential advantages beneficial in this patient population.

摘要

神经病理性疼痛(NeP)在周围神经病变(PN)患者中普遍存在,无论病因如何。我们旨在比较大麻素纳布隆作为单一疗法或辅助疗法与一线药物治疗神经病理性疼痛(加巴喷丁)在患有 PN-NeP 的患者人群中的疗效。诊断为 PN-NeP 的患者允许开始单一疗法(纳布隆或加巴喷丁)或在其现有的 NeP 治疗方案中添加这两种药物之一(辅助治疗)。在非随机开放标签的性质中收集基线数据,包括主要结局(疼痛的视觉模拟评分[VAS])和次要结局(生活质量[EuroQol 5 域和简短 36]评估和睡眠评估[医疗结果睡眠研究量表{MOSSS}],焦虑和抑郁[医院焦虑和抑郁量表],以及疼痛[简明疼痛量表])。在 3 个月和 6 个月的间隔进行重新评估和剂量调整/或药物治疗。在 6 个月时评估药物不良反应和药物疗效以及问卷。采用匹配方差分析比较 3 个月和 6 个月的评分与基线评分,以及在相同时间点比较治疗方法。在 6 个月时,所有治疗组的疼痛 VAS 均显著改善。接受纳布隆或加巴喷丁作为单一疗法或辅助治疗的患者,MOSSS、简明疼痛量表和简短 36 中的许多睡眠参数均得到改善。所有治疗组的医院焦虑和抑郁量表-A 评分均显著改善。MOSSS 中的睡眠充足度和睡眠问题指数在纳布隆单药治疗患者中尤其改善。纳布隆单药或辅助治疗的益处似乎与加巴喷丁治疗 NeP 相当。我们提倡对目前用于 NeP 的治疗方法进行头对头的随机、双盲研究,以确定对该患者人群有益的潜在优势。

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