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降钙素基因相关肽拮抗剂在偏头痛预防中的应用:关键性研究亮点及该新药类别的临床意义。

Calcitonin Gene-Related Peptide Antagonists for the Prevention of Migraine: Highlights From Pivotal Studies and the Clinical Relevance of This New Drug Class.

机构信息

Department of Neurology, Mayo Clinic Arizona, Scottsdale, AZ, USA.

Department of Pharmacy, Mayo Clinic Hospital, Phoenix, AZ, USA.

出版信息

Ann Pharmacother. 2020 Aug;54(8):795-803. doi: 10.1177/1060028020903417. Epub 2020 Feb 5.

Abstract

To review the new drug class of calcitonin gene-related peptide antagonists (monoclonal antibodies) and their clinical relevance in migraine prophylaxis. A literature search was performed in PubMed (January 2009 to November 2019) using the terms (CGRP), , and for clinical trials and studies. Reports from human studies in English were evaluated for clinical evidence supporting pharmacology, efficacy, and adverse events. Initial pharmacokinetic and preclinical studies were excluded. In chronic and episodic migraine, prophylaxis with injections of monoclonal antibodies antagonizing CGRP reduced monthly migraine days with minimal clinically significant adverse events. In addition, there is evidence supporting efficacy in refractory migraine despite optimal prophylaxis. This is the first target-specific migraine prophylaxis treatment to show efficacy with minimal adverse effects. A higher drug cost is a barrier but is balanced by improved quality of life. Current therapies have limited efficacy and tolerability because of poor side effect profiles. CGRP antagonists represent a shift to more precise migraine treatments. Monoclonal antibodies inhibiting CGRP are effective in migraine prophylaxis with minimal adverse effects. Targeting CGRP is a novel clinical strategy in managing migraine.

摘要

回顾降钙素基因相关肽拮抗剂(单克隆抗体)这一新的药物类别及其在偏头痛预防中的临床相关性。在 PubMed 上进行了文献检索(2009 年 1 月至 2019 年 11 月),使用的术语为(CGRP)、和,用于临床试验和研究。评估了来自英语人类研究的报告,以提供支持药理学、疗效和不良事件的临床证据。排除了初始药代动力学和临床前研究。在慢性和阵发性偏头痛中,用拮抗 CGRP 的单克隆抗体注射进行预防可减少每月偏头痛天数,且最小的临床显著不良事件。此外,有证据支持在最佳预防治疗的情况下难治性偏头痛的疗效。这是第一个显示出最小不良影响的靶向特定偏头痛预防治疗方法。较高的药物成本是一个障碍,但通过提高生活质量来平衡。由于不良影响特征不佳,当前的治疗方法疗效和耐受性有限。CGRP 拮抗剂代表了向更精确的偏头痛治疗方法的转变。抑制 CGRP 的单克隆抗体在偏头痛预防中有效,且不良影响最小。靶向 CGRP 是管理偏头痛的一种新的临床策略。

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