Dalessio Headache Center, Scripps Clinic, 10666 North Torrey Pines Rd. MS 313, La Jolla, CA, 92037, USA,
Neurol Sci. 2014 Mar;35(3):429-35. doi: 10.1007/s10072-013-1536-0. Epub 2013 Sep 13.
Migraine is a highly prevalent episodic and chronic neurological disorder that impacts otherwise healthy men and women in their most productive years. An anecdotal survey in our clinical practices suggested that milnacipran, a drug indicated for the treatment of fibromyalgia, reduced the incidence of headache in patients with migraine. In this 3-month, open-label, pilot study, 38 patients diagnosed with episodic migraine and 7 patients with chronic migraine maintained headache diaries to assess the effectiveness and tolerability of milnacipran in headache prevention. After a 1-month period to obtain baseline data, milnacipran treatment was initiated and doses were titrated up to 100 mg/day over 1 month. Maintenance therapy continued for an additional 3 months. The primary efficacy end point was change from baseline in the number of all headache days during the last 28 days of maintenance therapy analyzed, using last observation carried forward (LOCF). Change from baseline in migraine days during the last month of the maintenance period using LOCF was a secondary end point. Milnacipran 100 mg daily was associated with a significant reduction in headache (-4.2 days; P < 0.001) and migraine frequency (-2.2 days; P < 0.003). The adverse event profile was consistent with prior reports of milnacipran for the treatment of other conditions. However, compared with the recommended protocol, a more gradual increase in milnacipran dose was required to improve tolerability for some patients. The robust efficacy signal found in this study strongly suggests that a double-blind, placebo-controlled trial of milnacipran in migraine and chronic headache is warranted.
偏头痛是一种常见的发作性和慢性神经系统疾病，影响着大多数处于生产高峰期的健康男性和女性。我们的临床实践中的一项轶事调查表明，米那普仑是一种用于治疗纤维肌痛的药物，可降低偏头痛患者头痛的发生率。在这项为期 3 个月、开放性、先导性研究中，38 例发作性偏头痛患者和 7 例慢性偏头痛患者记录头痛日记，以评估米那普仑预防头痛的有效性和耐受性。在为期 1 个月的基线数据获取期后，开始米那普仑治疗，并在 1 个月内滴定剂量至 100mg/天。维持治疗持续 3 个月。主要疗效终点是使用末次观察值结转（LOCF）分析的维持治疗最后 28 天内所有头痛日数的基线变化。使用 LOCF 分析维持期最后 1 个月偏头痛日数的基线变化是次要终点。米那普仑 100mg/天与头痛显著减少（-4.2 天；P<0.001）和偏头痛发作频率显著减少（-2.2 天；P<0.003）相关。不良事件谱与先前米那普仑治疗其他疾病的报告一致。然而，与推荐方案相比，一些患者需要更缓慢地增加米那普仑剂量以提高耐受性。这项研究中发现的强大疗效信号强烈表明，米那普仑治疗偏头痛和慢性头痛的双盲、安慰剂对照试验是有必要的。
