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首页> 外文期刊>Cephalalgia >Safety and efficacy of PNU-142633, a selective 5-HT1D agonist, in patients with acute migraine.
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Safety and efficacy of PNU-142633, a selective 5-HT1D agonist, in patients with acute migraine.

机译:选择性5-HT1D激动剂PNU-142633在急性偏头痛患者中的安全性和有效性。

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摘要

In this randomized, double-blind, placebo-controlled, parallel-group study, patients received a single 50-mg oral dose of a 5-HT(1D) agonist, PNU-142633 (n = 34), or matching placebo (n = 35) during an acute migraine attack. No statistically significant treatment effects were observed at 1 and 2 h after dosing, even after stratifying by baseline headache intensity. At 1 and 2 h post-dose, 8.8% and 29.4% of the PNU-142633 group, respectively, and 8.6% and 40.0% of the placebo group, respectively, experienced headache relief; 2.9% and 8.8% of the PNU-142633 group and 0% and 5.7% of the placebo group were free of headache pain. Adverse events associated with PNU-142633 treatment included chest pain (two patients) and QTc prolongation (three patients). Results from this study suggest that anti-migraine efficacy is not mediated solely through the 5-HT(1D) receptor subtype, although this receptor may contribute, at least in part, to the adverse cardiovascular effects observed with 5-HT agonist medications.
机译:在这项随机,双盲,安慰剂对照,平行组研究中,患者接受了50 mg口服单剂量的5-HT(1D)激动剂PNU-142633(n = 34)或匹配的安慰剂(n = 35)在急性偏头痛发作期间。即使在基线头痛强度分层后,给药后1和2小时也未观察到统计学上显着的治疗效果。给药后1小时和2小时,PNU-142633组分别为8.8%和29.4%,安慰剂组分别为8.6%和40.0%。 PNU-142633组的2.9%和8.8%以及安慰剂组的0%和5.7%没有头痛。与PNU-142633治疗相关的不良事件包括胸痛(两名患者)和QTc延长(三名患者)。这项研究的结果表明,抗偏头痛功效并非仅通过5-HT(1D)受体亚型介导,尽管该受体可能至少部分地导致了使用5-HT激动剂药物观察到的不良心血管作用。

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