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HAVEN 研究-羟氯喹在 ANCA 血管炎评估中的作用：一项多中心、随机、双盲、安慰剂对照试验：研究方案和统计分析计划。

The HAVEN study-hydroxychloroquine in ANCA vasculitis evaluation-a multicentre, randomised, double-blind, placebo-controlled trial: study protocol and statistical analysis plan.

机构信息

School of Life Course and Population Sciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.

Clinical Trial Management Platform, Guy's and St Thomas' NHS Foundation Trust, London, UK.

出版信息

Trials. 2023 Apr 6;24(1):261. doi: 10.1186/s13063-023-07108-3.

DOI:10.1186/s13063-023-07108-3
PMID:37024906
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10077754/
Abstract

BACKGROUND

Patients with non-severe ANCA-associated vasculitis (AAV) are often prescribed immunosuppressive medications that are associated with severe side effects and a reduced quality of life. There is an unmet need for safer effective treatments for these patients. Hydroxychloroquine is being explored due to its effect in similar autoimmune conditions such as systemic lupus erythematosus.

METHODS

Double-blind, placebo-controlled multicentre trial recruiting 76 patients across 20 sites. Participants will be randomised 1:1 to hydroxychloroquine or placebo in addition to standard of care immunosuppressive therapies over the course of 52 weeks. A phase II selection design will be used to determine hdroxychloroquine's efficacy, using prednisolone dosage and Birmingham Vasculitis Activity Score as a measure of disease activity. Secondary outcomes will explore other elements of AAV progression, including disease flares and time to remission.

DISCUSSION

This trial aims to explore Hydroxychloroquine as a treatment for patients with AAV. If effective, the need for immunosuppressive treatments such as prednisolone could be reduced. Hydroxychloroquine is safer, cheaper and has fewer adverse effects than conventional immunosuppressive treatments. This could improve patient outcomes while saving money for the NHS.

TRIAL REGISTRATION

ISRCTN: ISRCTN79334891. Registered 07 June 2021. EudraCT: 2018-001268-40. Registered 13 September 2019.

CLINICALTRIALS

gov: NCT04316494. Registered 20 March 2020.

摘要

背景

非重症抗中性粒细胞胞浆抗体相关性血管炎（AAV）患者常需服用免疫抑制剂，但这些药物副作用严重，降低了患者的生活质量。因此，此类患者亟需更安全有效的治疗方法。羟氯喹由于在系统性红斑狼疮等自身免疫性疾病中的疗效而受到关注。

方法

这项在 20 个地点开展的双盲、安慰剂对照、多中心试验共纳入了 76 名患者。参与者将按 1:1 的比例随机分配至羟氯喹或安慰剂组，同时两组均接受标准的免疫抑制治疗，疗程为 52 周。采用二期选择设计来评估羟氯喹的疗效，以泼尼松剂量和伯明翰血管炎活动评分作为疾病活动的衡量指标。次要结局将探索 AAV 进展的其他方面，包括疾病复发和缓解时间。

讨论

本试验旨在探索羟氯喹治疗 AAV 患者的效果。如果有效，可能会减少对泼尼松等免疫抑制剂的需求。羟氯喹比传统免疫抑制剂更安全、更便宜、副作用更少，这可能会改善患者的预后，同时为 NHS 节省开支。

试验注册

ISRCTN：ISRCTN79334891。注册日期：2021 年 6 月 7 日。EudraCT：2018-001268-40。注册日期：2019 年 9 月 13 日。

临床试验

gov：NCT04316494。注册日期：2020 年 3 月 20 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1d93/10077754/4c022be957d5/13063_2023_7108_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1d93/10077754/4c022be957d5/13063_2023_7108_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1d93/10077754/4c022be957d5/13063_2023_7108_Fig1_HTML.jpg

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Impact of Trump's Promotion of Unproven COVID-19 Treatments and Subsequent Internet Trends: Observational Study.特朗普推广未经证实的新冠治疗方法的影响及随后的互联网趋势：观察性研究
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Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19.
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Rheumatol Adv Pract. 2023 Oct 24;7(3):rkad092. doi: 10.1093/rap/rkad092. eCollection 2023.
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