North James M, Hong Kyung-Soo J, Rauck Richard L
Carolinas Pain Institute and Center for Clinical Research, Winston-Salem, North Carolina, U.S.A.
Wake Forest University Baptist Medical Center, Pain Medicine and Anesthesiology, Winston-Salem, North Carolina, U.S.A.
Pain Pract. 2016 Jul;16(6):720-9. doi: 10.1111/papr.12319. Epub 2015 Jun 8.
We assessed the efficacy and safety of extended-release gabapentin in a 15-week, open-label, single-arm, single-center study in patients with fibromyalgia (FM).
Subjects with documented diagnosis of FM were allowed to participate in the study. We opened enrollment to those who have tried and failed gabapentinoids such as gabapentin or pregabalin due to side effects. Subjects with autoimmune conditions, and or taking opioids for management of their FM pain, were excluded from the study. Subjects were given an extended-release gabapentin starter pack and treated for total of 12 weeks. The primary study endpoint of pain relief was measured using Numeric Pain Rating System (NPRS) scores, and secondary study endpoints were measured with Fibromyalgia Impact Questionnaire (FIQ), Patient's Global Impression of Change (PGIC), and Medical Outcome Sleep questionnaires (MOS).
A total of 34 subjects were enrolled and 29 subjects completed the starter pack (85%). Patients reported significant pain relief on NPRS by end of 4 weeks (P < 0.0001) on NPRS. Subjects also reported similar magnitude of improvements in FM and its impact on daily life by end of 4 weeks on FIQ (P < 0.0001). Survey of MOS showed our subjects reporting improved sleep quantity (on average, 1.2 hours over baseline) with gradual and statistically significant improvement in quality. Improvements in primary and secondary measurements were reflected in PGIC, with significant improvement in patient's impression of FM by week 8.
Small sample size, geographical bias, relatively short duration of treatment, and single-arm study without control group.
Extended-release gabapentin relieved FM pain symptoms and improved quality-of-life for the FM subjects studied. Subjects reported improvements in both quantity and quality of sleep.
在一项针对纤维肌痛（FM）患者的为期15周的开放标签、单臂、单中心研究中，我们评估了缓释加巴喷丁的疗效和安全性。
确诊为FM的受试者可参与本研究。我们招募了那些因副作用而尝试使用加巴喷丁类药物（如加巴喷丁或普瑞巴林）但治疗失败的患者。患有自身免疫性疾病和/或正在服用阿片类药物来控制FM疼痛的受试者被排除在研究之外。受试者被给予一个缓释加巴喷丁起始包，并接受总共12周的治疗。使用数字疼痛评分系统（NPRS）分数来衡量疼痛缓解这一主要研究终点，使用纤维肌痛影响问卷（FIQ）、患者总体变化印象（PGIC）和医学结局睡眠问卷（MOS）来衡量次要研究终点。
总共招募了34名受试者，29名受试者完成了起始包治疗（85%）。患者在4周结束时报告NPRS上的疼痛有显著缓解（P < 0.0001）。受试者在4周结束时在FIQ上也报告FM及其对日常生活的影响有类似程度的改善（P < 0.0001）。MOS调查显示，我们的受试者报告睡眠量有所改善（平均比基线多1.2小时），且质量有逐渐且具有统计学意义的改善。主要和次要测量指标的改善在PGIC中得到体现，到第8周时患者对FM的印象有显著改善。
样本量小、存在地域偏差、治疗持续时间相对较短以及为无对照组的单臂研究。
缓释加巴喷丁缓解了所研究的FM受试者的疼痛症状并改善了生活质量。受试者报告睡眠的量和质均有改善。
