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European Academy of Neurology guidelines on the treatment of cluster headache.欧洲神经病学学会关于丛集性头痛治疗的指南。
Eur J Neurol. 2023 Oct;30(10):2955-2979. doi: 10.1111/ene.15956. Epub 2023 Jul 28.
2
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3
Network meta-analysis of therapies for cluster headache: Effects of acute therapies for episodic and chronic cluster.网络荟萃分析治疗丛集性头痛：发作性和慢性丛集性急性治疗的效果。
Headache. 2022 Apr;62(4):482-511. doi: 10.1111/head.14283. Epub 2022 Mar 28.
4
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5
Essential statistical principles of clinical trials of pain treatments.疼痛治疗临床试验的基本统计学原理。
Pain Rep. 2020 Dec 18;6(1):e863. doi: 10.1097/PR9.0000000000000863. eCollection 2021 Jan-Feb.
6
Cluster headache is one of the most intensely painful human conditions: Results from the International Cluster Headache Questionnaire.丛集性头痛是人类最剧烈的疼痛之一：国际丛集性头痛问卷的结果。
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7
Safety and efficacy of prednisone versus placebo in short-term prevention of episodic cluster headache: a multicentre, double-blind, randomised controlled trial.泼尼松与安慰剂短期预防发作性丛集性头痛的安全性和疗效：一项多中心、双盲、随机对照试验。
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Phase 3 randomized, placebo-controlled study of galcanezumab in patients with chronic cluster headache: Results from 3-month double-blind treatment.三期随机、安慰剂对照研究加巴喷丁治疗慢性丛集性头痛：3 个月双盲治疗结果。
Cephalalgia. 2020 Aug;40(9):935-948. doi: 10.1177/0333102420905321. Epub 2020 Feb 12.
9
Trial of Galcanezumab in Prevention of Episodic Cluster Headache.加巴喷丁预防发作性丛集性头痛的试验。
N Engl J Med. 2019 Jul 11;381(2):132-141. doi: 10.1056/NEJMoa1813440.
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J Headache Pain. 2018 Oct 10;19(1):94. doi: 10.1186/s10194-018-0917-4.

关于集群性头痛临床试验设计指南的评论及进一步建议。

Commentary on 2022 guidelines on clinical trial design in cluster headache and further suggestions.

机构信息

SUNY Upstate Medical University, Syracuse, New York, USA.

The New England Institute for Neurology and Headache, 30 Buxton Farms Rd, Stamford, CT, USA.

出版信息

J Headache Pain. 2024 Mar 7;25(1):32. doi: 10.1186/s10194-024-01732-3.

DOI:10.1186/s10194-024-01732-3
PMID:38454380
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10921584/
Abstract

BACKGROUND

New guidelines for cluster headache clinical trials were recently published. We welcome these new guidelines and raise additional considerations in trial methodologies.

MAIN BODY

We present non-inferiority trials to overcome ethical issues with placebo use, and additionally discuss issues with trial recruitment.

CONCLUSIONS

We highlight some possible issues and solutions to be considered with the recently published cluster headache trial guidelines.

摘要

背景

最近发布了簇状头痛临床试验的新指南。我们欢迎这些新指南，并在试验方法学方面提出了其他考虑因素。

主要内容

我们提出非劣效性试验以克服安慰剂使用的伦理问题，并进一步讨论试验招募的问题。

结论

我们强调了最近发布的簇状头痛试验指南中需要考虑的一些可能问题和解决方案。