Kaye Alan D, Beuno Franklin Rivera, Katalenich Bonnie, Stell Carol, Liu Henry, Rosinia Frank A, Luk Erik, Ehrhardt Ken, Fox Charles J
Department of Anesthesiology, Tulane School of Medicine, New Orleans, LA; Department of Anesthesiology, Tulane School of Medicine, New Orleans, LA; Tulane Medical School Clinical Research at the Clinical Translational Unit, New Orleans, LA; LSU School.
Pain Physician. 2014 Mar-Apr;17(2):169-78.
The health and efficacy profiles of Gralise® in the treatment of pain from spinal stenosis and radicular symptomatology have not been measured. A review of the current literature indicates that no studies exist that evaluate the safety and efficacy profiles of Gralise® in the treatment of pain from spinal stenosis and radicular symptomatology.
Our study is aimed at determining whether Gralise is a safe and effective pharmacotherapy for the pain from spinal stenosis and radicular symptomatology.
A 4-week prospective open label single arm and single center study of patients with MRI diagnosis of spinal stenosis with radicular pain.
The primary measure of efficacy was a change in average daily pain (ADP) score from baseline to completion of Gralise therapy for 4 weeks. The secondary efficacy endpoints were the patients' Patients Global Impression of Change Scale (PGIC), the clinician's Clinical Global Impression of Change Scale (CGI) reports, and the Medical Outcomes Study (MOS) sleep scale of improvement from baseline to completing 4 weeks of Gralise therapy. The safety and tolerability were evaluated by the incidence of adverse events reported while on Gralise therapy.
The study was performed at the Clinical Research Facilities at Tulane Medical Center, New Orleans, Louisiana, in the period from December 1, 2012, to August 30, 2013.
Thirty-five patients achieved an efficacy point of one-week Gralise medication treatment. Twenty-seven of 35 (77.2%) patients completed all 5 visits. The PGIC noted a significant positive change in: (1) activity limitations; (2) symptoms; (3) emotions and overall quality of life when related to their condition from first visit as well as improved degree of change when related to their condition from first to last visit. The MOS sleep scale and sleep diaries noted a significant increase of hours slept on average (an increase in over one hour per night--5.8 hours versus 6.86 hours) from the beginning of the study to the end. The CGI noted a majority of 10 out of 27 with marked significant therapeutic effect with no side effects. The ADP rating from pain intensity scale and pain diaries noted significant improvement of lesser levels of pain experienced (P =.5907 and P =.8547 respectively). No significant adverse effects were noted in the study.
Variation in degree of spinal stenosis, small sample size.
Gralise demonstrated moderate efficacy with reduced pain intensity and increased sleep and was well tolerated in spinal stenosis patients with radicular symptoms.
尚未对加巴喷丁缓释片（Gralise®）治疗椎管狭窄及神经根症状性疼痛的健康状况及疗效进行评估。对当前文献的回顾表明，尚无研究评估加巴喷丁缓释片治疗椎管狭窄及神经根症状性疼痛的安全性和疗效。
我们的研究旨在确定加巴喷丁缓释片对于椎管狭窄及神经根症状性疼痛是否为一种安全有效的药物治疗方法。
一项为期4周的前瞻性开放标签单臂单中心研究，研究对象为经磁共振成像（MRI）诊断为椎管狭窄伴神经根性疼痛的患者。
疗效的主要衡量指标为从基线到加巴喷丁缓释片治疗4周结束时平均每日疼痛（ADP）评分的变化。次要疗效终点为患者的患者总体印象变化量表（PGIC）、临床医生的临床总体印象变化量表（CGI）报告，以及从基线到加巴喷丁缓释片治疗4周结束时医学结局研究（MOS）睡眠改善量表。通过报告的加巴喷丁缓释片治疗期间不良事件的发生率评估安全性和耐受性。
该研究于2012年12月1日至2013年8月30日在路易斯安那州新奥尔良市杜兰医学中心的临床研究设施进行。
35例患者在接受一周的加巴喷丁缓释片药物治疗后达到疗效点。35例患者中有27例（77.2%）完成了全部5次访视。PGIC显示在以下方面有显著的积极变化：（1）活动受限；（2）症状；（3）与病情相关的情绪和总体生活质量，从首次访视时起，以及从首次访视到末次访视与病情相关的改善程度变化。MOS睡眠量表和睡眠日记显示，从研究开始到结束，平均睡眠时间显著增加（每晚增加超过1小时——从5.8小时增加到6.86小时）。CGI显示，27例患者中有10例大部分有显著治疗效果且无副作用。疼痛强度量表和疼痛日记的ADP评分显示，所经历的疼痛程度有显著改善（分别为P = 0.5907和P = 0.8547）。该研究未发现显著不良反应。
椎管狭窄程度存在差异，样本量小。
加巴喷丁缓释片在伴有神经根症状的椎管狭窄患者中显示出中度疗效，可减轻疼痛强度并增加睡眠时间，且耐受性良好。
