普瑞巴林与度洛西汀联合治疗纤维肌痛：一项随机对照试验。
Combination of pregabalin with duloxetine for fibromyalgia: a randomized controlled trial.
作者信息
Gilron Ian, Chaparro Luis E, Tu Dongsheng, Holden Ronald R, Milev Roumen, Towheed Tanveer, DuMerton-Shore Deborah, Walker Sarah
机构信息
Departments of aAnesthesiology and Perioperative Medicine and bBiomedical and Molecular Sciences, Queen's University, Kingston, Canada cUniversity of Toronto, Department of Anesthesia, University of Toronto, Toronto, Canada dPublic Health Sciences eMathematics and Statistics fPsychology and gPsychiatry, Queen's University, Kingston, Canada hDivision of Rheumatology, Department of Medicine Queen's University, Kingston, ON, Canada iDepartment of Anesthesiology and Perioperative Medicine, Queen's University, Kingston, Canada.
出版信息
Pain. 2016 Jul;157(7):1532-40. doi: 10.1097/j.pain.0000000000000558.
Fibromyalgia is a syndrome characterized by chronic widespread pain and associated with sleep disturbance, depression, fatigue, and cognitive dysfunction. Polypharmacy is commonly used, but supportive evidence is limited. Most fibromyalgia trials focus primarily on pain reduction with monotherapy. This trial compares a pregabalin-duloxetine combination to each monotherapy. Using a randomized, double-blind, 4-period crossover design, participants received maximally tolerated doses of placebo, pregabalin, duloxetine, and pregabalin-duloxetine combination-for 6 weeks. Primary outcome was daily pain (0-10); secondary outcomes included global pain relief, Fibromyalgia Impact Questionnaire, SF-36 survey, Medical Outcomes Study Sleep Scale, Beck Depression Inventory (BDI-II), adverse events, and other measures. Of 41 participants randomized, 39 completed ≥2 treatments. Daily pain during placebo, pregabalin, duloxetine, and combination was 5.1, 5.0, 4.1, and 3.7, respectively (P < 0.05 only for combination vs placebo, and pregabalin). Participants (%) reporting ≥moderate global pain relief were 18%, 39%, 42%, and 68%, respectively (P < 0.05 for combination vs placebo, pregabalin, and duloxetine). Fibromyalgia Impact Questionnaire scores were 42.9, 37.4, 36.0, and 29.8, respectively (P < 0.05 for combination vs placebo, pregabalin, and duloxetine). SF-36 scores were 50.2, 55.7, 56.0, and 61.2, respectively (P < 0.05 for combination vs placebo, pregabalin, and duloxetine). Medical Outcomes Study Sleep Scale scores were 48.9, 35.2, 46.1, and 32.1, respectively (P < 0.05 only for combination vs placebo, and duloxetine). BDI-II scores were 11.9, 9.9, 10.7, and 8.9, respectively (P < 0.05 only for combination vs placebo). Moderate-severe drowsiness was more frequent during combination vs placebo. Combining pregabalin and duloxetine for fibromyalgia improves multiple clinical outcomes vs monotherapy. Continued research should compare this and other combinations to monotherapy for fibromyalgia.
纤维肌痛是一种以慢性广泛性疼痛为特征的综合征，伴有睡眠障碍、抑郁、疲劳和认知功能障碍。多药联合治疗常用，但支持证据有限。大多数纤维肌痛试验主要关注单一疗法的疼痛减轻情况。本试验比较了普瑞巴林 - 度洛西汀联合用药与每种单一疗法的效果。采用随机、双盲、4期交叉设计，参与者接受最大耐受剂量的安慰剂、普瑞巴林、度洛西汀和普瑞巴林 - 度洛西汀联合用药，为期6周。主要结局指标是每日疼痛程度（0 - 10分）；次要结局指标包括总体疼痛缓解情况、纤维肌痛影响问卷、SF - 36调查、医学结局研究睡眠量表、贝克抑郁量表（BDI - II）、不良事件及其他指标。在随机分组的41名参与者中，39人完成了≥2种治疗。安慰剂、普瑞巴林、度洛西汀和联合用药期间的每日疼痛程度分别为5.1、5.0、4.1和3.7（仅联合用药组与安慰剂组及普瑞巴林组相比，P < 0.05）。报告有≥中度总体疼痛缓解的参与者比例分别为18%、39%、42%和68%（联合用药组与安慰剂组、普瑞巴林组和度洛西汀组相比，P < 0.05）。纤维肌痛影响问卷得分分别为42.9、37.4、36.0和29.8（联合用药组与安慰剂组、普瑞巴林组和度洛西汀组相比，P < 0.05）。SF - 36得分分别为50.2、55.7、56.0和61.2（联合用药组与安慰剂组、普瑞巴林组和度洛西汀组相比，P < 0.05）。医学结局研究睡眠量表得分分别为48.9、35.2、46.1和32.1（仅联合用药组与安慰剂组及度洛西汀组相比，P < 0.05）。BDI - II得分分别为11.9、9.9、10.7和8.9（仅联合用药组与安慰剂组相比，P < 0.05）。联合用药组与安慰剂组相比，中度至重度嗜睡更为常见。与单一疗法相比，普瑞巴林和度洛西汀联合治疗纤维肌痛可改善多项临床结局。后续研究应比较这种联合用药及其他联合用药与纤维肌痛单一疗法的效果。
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