Lankenau Medical Center, Wynnewood, PA 19096, USA.
Headache. 2012 Feb;52(2):204-12. doi: 10.1111/j.1526-4610.2011.02065.x. Epub 2012 Jan 9.
To evaluate the efficacy and safety of transdermal sumatriptan in migraine patients who have baseline nausea.
Migraine-associated nausea and vomiting can limit the effectiveness of acute treatment with oral agents by causing delays, avoidance, or incomplete absorption of medication due to post-dose vomiting.
In a multicenter, randomized, double-blind, placebo-controlled study in adult (aged 18-66 years) migraineurs, 530 patients were randomized to receive transdermal sumatriptan or a placebo patch and remained in the study until they had treated a single moderate to severe migraine attack or had gone 2 months without treatment. At baseline (before applying the study patch), patients recorded headache pain intensity and the presence or absence of migraine-associated symptoms, including nausea. The use of analgesic or anti-emetic rescue medications within 2 hours of patch activation was prohibited. Post-hoc analyses were conducted to assess the proportion of patients with nausea at baseline who experienced headache relief and who were free from nausea, photophobia, and phonophobia at 1 and 2 hours post-activation.
A total of 454 patients were included in the intent-to-treat population for efficacy analyses. Baseline demographic and migraine headache characteristics were generally similar between the treatment groups. In the overall study population, transdermal sumatriptan was significantly superior to placebo at 1 hour post-activation for pain relief (29% vs 19%, respectively; P < .0135) and freedom from nausea (71% vs 58%, respectively; P < .05) and at 2 hours post-activation for freedom from pain (18% vs 9%, respectively; P < .009), pain relief (53% vs 29%, respectively; P < .0001), freedom from nausea (84% vs 63% respectively; P < .001), freedom from photophobia (51% vs 36%, respectively; P < .0028), freedom from phonophobia (55% vs 39%, respectively; P < .0002); and freedom from migraine (16% vs 8%, respectively; P < .0135). In the post-hoc analysis, transdermal sumatriptan was markedly superior to placebo for pain relief and freedom from pain, nausea, photo-, and phonophobia at 1 and 2 hours post-activation.
Transdermal sumatriptan is superior to oral triptans for migraine patients whose baseline nausea causes them to delay or avoid acute treatment.
评估曲坦透皮贴剂治疗伴有基线期恶心的偏头痛患者的疗效和安全性。
偏头痛相关的恶心和呕吐可能会因用药后呕吐导致药物延迟吸收、避免用药或药物不完全吸收，从而限制口服药物的急性治疗效果。
在一项多中心、随机、双盲、安慰剂对照的成年（18-66 岁）偏头痛患者研究中，530 例患者被随机分配接受曲坦透皮贴剂或安慰剂贴片治疗，直至他们单次治疗中度至重度偏头痛发作或 2 个月未治疗。在基线期（贴敷研究贴片前），患者记录头痛疼痛强度和偏头痛相关症状（包括恶心）的存在或不存在。在贴片激活后 2 小时内禁止使用镇痛药或止吐药进行解救治疗。进行事后分析以评估基线期有恶心的患者中，在贴片激活后 1 和 2 小时缓解头痛、无恶心、畏光和畏声的比例。
共有 454 例患者纳入疗效分析的意向治疗人群。治疗组的基线人口统计学和偏头痛头痛特征通常相似。在总体研究人群中，与安慰剂相比，曲坦透皮贴剂在激活后 1 小时时在缓解疼痛（分别为 29%和 19%；P<.0135）和无恶心（分别为 71%和 58%；P<.05）方面显著更优，在激活后 2 小时时在无疼痛（分别为 18%和 9%；P<.009）、缓解疼痛（分别为 53%和 29%；P<.0001）、无恶心（分别为 84%和 63%；P<.001）、无畏光（分别为 51%和 36%；P<.0028）、无畏声（分别为 55%和 39%；P<.0002）和无偏头痛（分别为 16%和 8%；P<.0135）方面显著更优。事后分析显示，在激活后 1 和 2 小时，曲坦透皮贴剂在缓解疼痛和无疼痛、恶心、畏光、畏声方面明显优于安慰剂。
与口服曲坦类药物相比，对于基线期恶心导致患者延迟或避免急性治疗的偏头痛患者，曲坦透皮贴剂更优。
