A double-blind placebo-controlled trial of milnacipran in the treatment of fibromyalgia
A double-blind placebo-controlled trial of milnacipran in the treatment of fibromyalgia
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DOI：
10.1002/hup.622
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发表时间：
2004-10-01
影响因子：
1.7
通讯作者：
Rao, SG
中科院分区：
文献类型：
--
作者：
Vitton, O;Gendreau, M;Rao, SG
纤维肌痛综合征是一种广泛疼痛的全身性疾病，被认为是中枢神经系统内异常疼痛处理的结果。目前尚无针对该适应症的获批治疗。然而，抗抑郁药似乎是有效的，特别是那些对去甲肾上腺素能神经传递有作用的药物。本研究的目的是测试双重作用的去甲肾上腺素和5-羟色胺再摄取抑制剂抗抑郁药米那普仑治疗纤维肌痛的疗效。125名患者参加了一项双盲、安慰剂对照、灵活的剂量递增试验，随机接受安慰剂或米那普仑，剂量递增4周（高达200 mg/天），随后以恒定剂量给药8周。该研究评估了米那普仑治疗疼痛和相关症状（如疲劳、抑郁情绪和睡眠）的有效性和安全性。75%的米那西泮治疗患者报告总体改善，而安慰剂组为38%（p < 0.01）。此外，37%的每日两次米那西泮治疗的患者报告疼痛强度降低至少50%，而安慰剂治疗的患者为14%（p < 0.05）。所有米那普仑患者中有84%递增至最高剂量（200 mg/天），没有耐受性问题。大多数不良事件的强度为轻度至中度，持续时间为一过性。这些结果表明，米那普仑可能不仅有可能缓解疼痛，还可能缓解与纤维肌痛相关的其他几种症状。版权所有（C）2004约翰威利父子有限公司。
Fibromyalgia syndrome is a systemic disorder of widespread pain which is thought to result from abnormal pain processing within the central nervous system. There are no currently approved treatments for this indication. Antidepressants appear, however, to be effective, especially those with an action on noradrenergic neurotransmission. The objective of the present study was to test the efficacy of the dual action noradrenaline and serotonin reuptake inhibitor antidepressant, milnacipran, in the treatment of fibromyalgia.The 125 patients, who were enrolled in a double-blind, placebo-controlled, flexible dose escalation trial, were randomized to receive placebo or milnacipran for 4 weeks of dose escalation (up to 200 mg/day), followed by 8 weeks at a constant dose. The study evaluated the efficacy and safety of milnacipran for the treatment of pain and associated symptoms such as fatigue, depressed mood and sleep. 75% of milnacipran-treated patients reported overall improvement, compared with 38% in the placebo group (p < 0.01). Furthermore, 37% of twice daily milnacipran-treated patients reported at least 50% reduction in pain intensity, compared with 14% of placebo-treated patients (p < 0.05). 84% of all milnacipran patients escalated to the highest dose (200 mg/day) with no tolerability issues. Most adverse events were mild to moderate in intensity, and transient in duration. These results suggest that milnacipran may have the potential to relieve not only pain but several of the other symptoms associated with fibromyalgia. Copyright (C) 2004 John Wiley Sons, Ltd.