秋水仙碱对稳定型冠心病患者血小板功能的影响：ECLIPSE前期研究
IF 3
Q2 CARDIAC & CARDIOVASCULAR SYSTEMS
引用次数: 0
摘要
这项前瞻性单臂药理学研究评估了秋水草碱（COLC） [Strides Pharma UK Ltd, Watford, Hertfordshire, England] 0.5 mg，每天口服一次，连续14天对血小板反应性的影响，与阿司匹林反应单位（ARUs）和P2Y12反应单位（pru）有关。方法：选取22例每日维持阿司匹林和氯吡格雷双重抗血小板治疗（DAPT）的稳定型冠心病（CAD）患者。使用VerifyNow™ARU和PRU测定（Werfen, Bedford， MA， USA）评估基线血小板功能，并评估COLC完成后每天一次0.5 mg，持续14天。结果：本研究中，ARU基线评分中位数为463，colc后评分中位数为436，差异无统计学意义（p = 0.485）。评分的平均差异为-18.31（95%可信区间[CI] -74.34 ~ 37.71, p = 0.504）。在基线时，27.3%的患者有“阿司匹林抵抗”或无反应，而colc后为13.6% （p = 0.423）。基线PRU评分中位数为210，colc后PRU评分中位数为199，差异无统计学意义（p = 0.581）。评分的平均差异为-7.31 （95% CI -31.1 ~ 16.5, p = 0.530）。在基线时，50%的患者有“氯吡格雷耐药”或无反应，而colc后为45.5% （p = 0.999）。2例患者在试验期间出现轻度胃肠道不适，COLC治疗未中断，无严重不良事件或治疗后出现的不良事件。结论：稳定期冠心病患者colc后ARUs和pru无显著差异。该初步药效学研究可为DAPT患者提供临床信息。需要进一步的研究来证实这些探索性的发现。试验注册：ClinicalTrials.gov识别码，NCT06567678，预期注册20/8/2024。本文章由计算机程序翻译，如有差异，请以英文原文为准。
The Effect of Colchicine on Platelet Function Profiles in Patients with Stable Coronary Artery Disease: The ECLIPSE Pilot Study.
Introduction: This prospective, single-arm pharmacodynamic study assessed the effect of colchicine (COLC) [Strides Pharma UK Ltd, Watford, Hertfordshire, England] 0.5 mg administered orally once daily for 14 days on platelet reactivity with respect to aspirin reaction units (ARUs) and P2Y12 reaction units (PRUs).
Methods: Twenty-two patients with stable coronary artery disease (CAD) on dual antiplatelet therapy (DAPT) with daily maintenance aspirin and clopidogrel were recruited. Baseline platelet function was evaluated with the VerifyNow™ ARU and PRU assays (Werfen, Bedford, MA, USA) and assessed post-completion of COLC 0.5 mg once daily for 14 days.
Results: In this study, the median ARU baseline score was 463, and post-COLC it was 436, which was not statistically significant (p = 0.485). The mean difference in scores was -18.31 (95% confidence interval [CI] -74.34 to 37.71, p = 0.504). At baseline, 27.3% of the patients had "aspirin resistance" or were non-responders, compared to 13.6% post-COLC (p = 0.423). The median baseline PRU score was 210, and post-COLC it was 199, which was also not statistically significant (p = 0.581). The mean difference in scores was -7.31 (95% CI -31.1 to 16.5, p = 0.530). At baseline, 50% of the patients had "clopidogrel resistance" or were non-responders, compared to 45.5% post-COLC (p = 0.999). Two patients experienced mild gastrointestinal upset during the trial without interruption of COLC, and there were no serious adverse events or treatment-emergent adverse events.
Conclusions: There were no significant differences in ARUs and PRUs post-COLC trial in patients with stable CAD. This pilot pharmacodynamic study could be clinically informative in patients on DAPT. Further studies are required to confirm these exploratory findings.
Trial registration: ClinicalTrials.gov identifier, NCT06567678, prospectively registered 20/8/2024.
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来源期刊
Cardiology and Therapy
CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
5.30
自引率
0.00%
发文量
38
审稿时长
6 weeks
期刊介绍：
Aims and Scope
Cardiology and Therapy is an international, open access, peer reviewed (single-blind), rapid-publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of cardiovascular therapies and interventions, including devices. Studies relating to diagnosis and diagnostics, pharmacoeconomics, public health, quality of life, as well as patient care, management and education are also encouraged.
Areas of focus include, but are not limited to, ischaemic heart disease and acute cardiac care, myocardial, valvular, pericardial and congenital heart disease, vascular and pulmonary disease (including hypertension), arrhythmias, heart failure, non-invasive diagnostic techniques, and invasive and interventional cardiology as well as cardiovascular surgery.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols and short communications such as commentaries and editorials. Cardiolology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals.
Rapid Publication
The journal’s publication timelines aim for a rapid peer review of 2 weeks. If an article is accepted it will be published 3–4 weeks from acceptance. The rapid timelines are achieved through the combination of a dedicated in-house editorial team, who manage article workflow, and an extensive Editorial and Advisory Board who assist with peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid, efficient communication of the latest research and reviews, fostering the advancement of cardiovascular therapies.
Personal Service
The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning authors will always have an editorial contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE, GPP and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research.
Digital Features and Plain Language Summaries
Cardiology and Therapy offers a range of additional features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by key summary points, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand the scientific content and overall implications of the article. The journal also provides the option to include various types of digital features including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations. All additional features are peer reviewed to the same high standard as the article itself. If you consider that your paper would benefit from the inclusion of a digital feature, please let us know. Our editorial team are able to create high-quality slide decks and infographics in-house, and video abstracts through our partner Research Square, and would be happy to assist in any way we can. For further information about digital features, please contact the journal editor (see ‘Contact the Journal’ for email address), and see the ‘Guidelines for digital features and plain language summaries’ document under ‘Submission guidelines’.
For examples of digital features please visit our showcase page https://springerhealthcare.com/expertise/publishing-digital-features/
Publication Fees
Upon acceptance of your article for publication, authors will be required to pay the mandatory Rapid Service Fee of £3650/€4500/$5100. The journal will consider fee discounts for developing countries and this is decided on a case by case basis.
Open Access
All articles published by Cardiology and Therapy are published open access.
Peer Review Process
Upon submission, manuscripts are assessed by the editorial team to ensure they fit within the aims and scope of the journal and are also checked for plagiarism. All suitable submissions are then subject to a comprehensive single-blind peer review. Reviewers are selected based on their relevant expertise and publication history in the subject area. The journal has an extensive pool of editorial and advisory board members who have been selected to assist with peer review based on the afore-mentioned criteria.
At least two extensive reviews are required to make the editorial decision, with the exception of some article types such as Commentaries, Editorials and Letters which are generally reviewed by one member of the Editorial Board. Where reviewer recommendations are conflicted, the editorial board will be contacted for further advice and a presiding decision. Manuscripts are then either accepted, rejected or authors are required to make major or minor revisions (both reviewer comments and editorial comments may need to be addressed). Once a revised manuscript is re-submitted, it is assessed along with the responses to reviewer comments and if it has been adequately revised it will be accepted for publication. Accepted manuscripts are then copyedited and typeset by the production team before online publication. Appeals against decisions following peer review are considered on a case by case basis and should be sent to the journal editor.
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We encourage posting of preprints of primary research manuscripts on preprint servers, authors’ or institutional websites, and open communications between researchers whether on community preprint servers or preprint commenting platforms. Posting of preprints is not considered prior publication and will not jeopardize consideration in our journals. Authors should disclose details of preprint posting during the submission process or at any other point during consideration in one of our journals. Once the preprint is published, it is the author’s responsibility to ensure that the preprint record is updated with a publication reference, including the DOI and a URL link to the published version of the article on the journal website.
Copyright
Cardiology and Therapy is published under the Creative Commons Attribution-Noncommercial License, which allows users to read, copy, distribute, and make derivative works for non-commercial purposes from the material, as long as the author of the original work is cited. The author assigns the exclusive right to any commercial use of the article to Springer. For more information about the Creative Commons Attribution-Noncommercial License, click here: http://creativecommons.org/licenses/by-nc/4.0.
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