Gallagher R M
University Headache Center, University of Medicine and Dentistry of New Jersey, Moorestown, USA.
Arch Neurol. 1996 Dec;53(12):1285-91. doi: 10.1001/archneur.1996.00550120097022.
Despite the benefits of antimigraine medications for patients with migraines, parenteral administration of these drugs has certain disadvantages for at-home patient use.
To examine the safety and efficacy of an intranasal spray formulation of dihydroergotamine mesylate in the treatment of migraines.
Double-blind, placebo-controlled trial in patients with migraines.
Both private and institutional practice.
A total of 348 patients with a diagnosis of migraine according to International Headache Society criteria were recruited; 310 patients qualified for participation.
Patients self-administered either 2 mg of dihydroergotamine mesylate, 3 mg of dihydroergotamine mesylate, or a placebo for each of 2 moderate to severe migraine headaches using a nasal spray apparatus.
Patients rated pain severity, functional ability, headache pain relief, incidence and severity of nausea, and the incidence of vomiting, photophobia, and phonophobia prior to treatment (base-line) and again at 0.5, 1, 2, 3, and 4 hours after treatment. Recurrences of headache pain within 24 hours were also noted.
Self-administration of dihydroergotamine resulted in significant increases in pain relief and functional ability and significant decreases in pain intensity and nausea compared with the placebo. Among patients treated with 2 mg of dihydroergotamine mesylate, 27% considered their migraine resolved (ie, no pain or mild pain) as early as 30 minutes after treatment. By 4 hours after treatment, 70% of these patients' headaches were resolved. Headache pain returned within 24 hours in only 14% of patients whose headaches had been resolved. No serious adverse effects of dihydroergotamine treatment were observed, and the adverse events that did occur were primarily related to the route of administration. The 2-mg dihydroergotamine mesylate dose provided slightly superior pain relief and was associated with fewer adverse events compared with the 3-mg dihydroergotamine mesylate dose.
The present results suggest that intranasal administration of dihydroergotamine represents an important new therapeutic option for migraine sufferers.
尽管抗偏头痛药物对偏头痛患者有益，但这些药物的肠胃外给药方式对于患者在家中使用存在一定弊端。
研究甲磺酸二氢麦角胺鼻喷雾剂治疗偏头痛的安全性和有效性。
针对偏头痛患者的双盲、安慰剂对照试验。
私人诊所和医疗机构。
根据国际头痛协会标准，共招募了348例诊断为偏头痛的患者；310例符合参与条件。
患者使用鼻喷雾装置，针对2次中度至重度偏头痛发作，每次自行使用2毫克甲磺酸二氢麦角胺、3毫克甲磺酸二氢麦角胺或安慰剂。
患者在治疗前（基线）以及治疗后0.5、1、2、3和4小时，对疼痛严重程度、功能能力、头痛疼痛缓解情况、恶心的发生率和严重程度以及呕吐、畏光和畏声的发生率进行评分。还记录了24小时内头痛疼痛的复发情况。
与安慰剂相比，自行使用甲磺酸二氢麦角胺可显著提高疼痛缓解程度和功能能力，显著降低疼痛强度和恶心程度。在接受2毫克甲磺酸二氢麦角胺治疗的患者中，27%的患者认为其偏头痛在治疗后30分钟内得到缓解（即无疼痛或轻度疼痛）。治疗后4小时，这些患者中70%的头痛得到缓解。头痛已缓解的患者中，只有14%在24小时内头痛复发。未观察到甲磺酸二氢麦角胺治疗的严重不良反应，且所发生的不良事件主要与给药途径有关。与3毫克甲磺酸二氢麦角胺剂量相比，2毫克甲磺酸二氢麦角胺剂量的止痛效果略优，且不良事件较少。
目前的结果表明，甲磺酸二氢麦角胺鼻内给药是偏头痛患者重要的新治疗选择。
