Prospective real-world analysis of OnabotulinumtoxinA in chronic migraine post-National Institute for Health and Care Excellence UK technology appraisal
Prospective real-world analysis of OnabotulinumtoxinA in chronic migraine post-National Institute for Health and Care Excellence UK technology appraisal
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DOI：
10.1111/ene.13657
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发表时间：
2018-08-01
影响因子：
5.1
通讯作者：
Lambru, G.
中科院分区：
文献类型：
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作者：
Andreou, A. P.;Trimboli, M.;Lambru, G.
背景和目的英国国家健康与护理卓越研究所（NICE）建议在慢性偏头痛（CM）的管理中使用OnabotulinumtoxinA（BoNTA，Botox（（R），遵循国家卫生服务中的特定指南。鉴于在临床实践中实施这些指南后这种疗法的疗效缺乏数据，以及对指南依从性的评估，我们的目的是评估BoNTA在CM患者中遵循NICE guidelines.MethodsThis的有效性和安全性是一项前瞻性的真实生活审计研究。200例患者中有127例（63.5%）的头痛天数至少减少30%。与基线相比，那些持续治疗长达3年的患者报告了稳定的有益效果。在应答者中，68例患者（53.5%）被重新分类为发作性偏头痛。在6个月的随访中，共有57例患者（83.8%）转为发作性偏头痛模式。大多数在BoNTA后偏头痛发作的患者在注意到头痛恶化之前将治疗间隔延长至3个月以上（范围4-8个月）。我们观察到155 U BoNTA治疗的患者与>155 U BoNTA.ConclusionsWhen根据NICE指导给药的患者相比，疗效指标无显著差异，BoNTA在CM的长期管理中产生了有临床意义的效果，有或无药物过度使用头痛。在临床实践中，当CM成为偶发性时停止治疗可能有助于识别可能从延长治疗间隔中获益的患者。我们的临床经验表明，使用“跟随疼痛”范式缺乏额外的益处。
Background and purposeThe National Institute for Health and Care Excellence (NICE) in the UK recommends the use of OnabotulinumtoxinA (BoNTA, Botox((R))) in the management of chronic migraine (CM) following specific guidelines within the National Health Service. In view of the lack of data on the efficacy of this therapy following implementation of these guidelines in clinical practice and on the evaluation of guidance compliance, we aimed to evaluate the effectiveness and safety of BoNTA in patients with CM following the NICE guidelines.MethodsThis was a prospective real-life audit study.ResultsAfter two treatments, 127 of 200 patients (63.5%) obtained at least a 30% reduction in headache days. Those who continued the treatment up to 3 years reported a stable beneficial effect compared with baseline. Amongst responders, 68 patients (53.5%) were reclassified as episodic migraineurs. A total of 57 of these patients (83.8%) converted to an episodic migraine pattern at 6-month follow-up. The majority of those whose migraine became episodic after BoNTA extended the treatment intervals beyond 3 months (range 4-8 months) before noticing any worsening of headache. We observed no significant differences in the efficacy measures in patients treated with 155 U BoNTA compared with those treated with >155 U BoNTA.ConclusionsWhen administered according to the NICE guidance, BoNTA produced a clinically meaningful effect in the long-term management of CM with and without medication overuse headache. Treatment discontinuation when CM becomes episodic may be useful in clinical practice to identify those who may benefit from extended treatment intervals. Our clinical experience indicates a lack of additional benefit from using the follow-the-pain' paradigm.