The Efficacy and Safety of Milnacipran for Treatment of Fibromyalgiae. A Randomized, Double-blind, Placebo-controlled Trial
The Efficacy and Safety of Milnacipran for Treatment of Fibromyalgiae. A Randomized, Double-blind, Placebo-controlled Trial
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DOI：
10.3899/jrheum.080734
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发表时间：
2009-02-01
影响因子：
3.9
通讯作者：
Palmer, Robert H.
中科院分区：
文献类型：
--
作者：
Mease, Philip J.;Clauw, Daniel J.;Palmer, Robert H.
目标。评价双去甲肾上腺素和5 -羟色胺再摄取抑制剂米那西普兰治疗纤维肌痛（FM）的安全性和有效性。一项为期27周的随机、双盲、多中心研究比较了milnacpran 100和200mg /天与安慰剂治疗888例FM患者。两种复合应答者定义用于对每个患者对治疗的个体应答进行分类。“FM应答者”同时满足疼痛改善（视觉模拟量表24小时晨间回忆）、患者整体印象变化（PGIC）和身体功能（SF-36 physical Component Summary）的反应标准；而“FM疼痛反应者”同时满足疼痛和pgic改善的反应标准。在主要终点，经过3个月的稳定剂量治疗后，与安慰剂相比，milnacpran治疗的患者达到FM应答标准的比例明显更高（milnacpran 200 mg/天，p = 0.017； milnacpran 100 mg/天，p = 0.028）。与安慰剂相比，接受milnaciran 200mg /天治疗的患者也符合FM疼痛反应标准的比例明显更高（p = 0.032）。两种剂量的milnacpran在第1周后观察到明显的疼痛减轻。在15周时，milnaciran 200 mg/天在疼痛（实时、每日和每周回忆；所有测量，p < 0.05）、PGIC （p < 0.001）、疲劳（p = 0.016）、认知（p = 0.025）和多个SF-36域方面比安慰剂有显著改善。在27周的治疗期间，米尔纳西普兰对大多数患者是安全且耐受性良好的；恶心和头痛是最常见的不良反应。米那西普兰对多发性FM症状的治疗安全有效。（首次发布2008年12月15日；J Rheumatol 2009;36:398-409; doi:10.3899/ jrheumat. 080734）
Objective. To evaluate the safety and efficacy of milnacipran, a dual norepinephrine and serotonin reuptake inhibitor, in the treatment of fibromyalgia (FM).Methods. A 27-week, randomized, double-blind, multicenter study compared milnacipran 100 and 200 mg/day with placebo in the treatment of 888 patients with FM. Two composite responder definitions were used to classify each patient's individual response to therapy. "FM responders" concurrently satisfied response criteria for improvements in pain (visual analog scale 24-h morning recall), patient global impression of change (PGIC), and physical functioning (SF-36 Physical Component Summary); while "FM pain responders" concurrently satisfied response criteria for improvements in pain and PGIC.Results. At the primary endpoint, after 3-month stable dose treatment, a significantly higher percentage of milnacipran-treated patients met criteria as FM responders versus placebo (milnacipran 200 mg/day, p = 0.017; milnacipran 100 mg/day, p = 0.028). A significantly higher percentage of patients treated with milnacipran 200 mg/day also met criteria as FM pain responders versus placebo (p = 0.032). Significant pain reductions were observed after Week 1 with both milnacipran doses. At 15 weeks, milnacipran 200 mg/day led to significant improvements over placebo in pain (real-time, daily and weekly recall; all measures, p < 0.05), PGIC (p < 0.001), fatigue (p = 0.016), cognition (p = 0.025), and multiple SF-36 domains. Milnacipran was safe and well tolerated by the majority of patients during 27 weeks of treatment; nausea and headache were the most common adverse events.Conclusion. Milnacipran is safe and effective for the treatment of multiple symptoms of FM. (First Release Dec 15 2008; J Rheumatol 2009;36:398-409; doi:10.3899/jrheum.080734)