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2019冠状病毒病大流行期间对超说明书用药的伦理审查

Ethical review of off-label drugs during the COVID-19 pandemic.

作者信息

Li Qiu-Yu, Lv Ye, An Zhuo-Yu, Dai Ni-Ni, Hong Xue, Zhang Yu, Liang Li-Jun

机构信息

Department of Pulmonary and Critical Care Medicine, Peking University Third Hospital, Beijing 100191, China.

Advanced Institute for Medical Sciences, Dalian Medical University, Dalian 116044, Liaoning Province, China.

出版信息

World J Clin Cases. 2022 Jun 16;10(17):5541-5550. doi: 10.12998/wjcc.v10.i17.5541.

DOI:10.12998/wjcc.v10.i17.5541
PMID:35979109
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9258355/
Abstract

High-quality scientific research is very important in attempting to effectively control the coronavirus disease 2019 (COVID-19) pandemic and ensure people's health and safety. Chloroquine (CQ) and hydroxychloroquine (HCQ) have received much attention. This article comprehensively investigates the ethical review of off-label CQ and HCQ research during the COVID-19 pandemic with regard to strictly abiding by review standards, improving review efficiency, ensuring the rights and interests of subjects and that ethics committees conduct independent reviews, and achieving full ethics supervision of research conducted during an emergency. Research must be both rigorous and prudent to ensure the best outcome, with the maximization of benefits as the core principle. Standardization of the application, implementation and ethical review processes are needed to prevent unnecessary risk.

摘要

高质量的科学研究对于有效控制2019冠状病毒病(COVID-19)大流行以及保障人们的健康和安全至关重要。氯喹(CQ)和羟氯喹(HCQ)备受关注。本文全面探讨了在COVID-19大流行期间,针对氯喹和羟氯喹的非标签研究进行伦理审查的相关问题,包括严格遵守审查标准、提高审查效率、保障受试者权益以及确保伦理委员会进行独立审查,从而实现对紧急情况下开展的研究进行全面伦理监督。研究必须严谨审慎以确保最佳结果,以利益最大化为核心原则。需要对应用、实施及伦理审查过程进行规范,以防止不必要的风险。

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本文引用的文献

1
Preliminary evidence from a multicenter prospective observational study of the safety and efficacy of chloroquine for the treatment of COVID-19.一项关于氯喹治疗COVID-19安全性和有效性的多中心前瞻性观察性研究的初步证据。
Natl Sci Rev. 2020 May 28;7(9):1428-1436. doi: 10.1093/nsr/nwaa113. eCollection 2020 Sep.
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Rehabilitation of Neuromuscular Diseases During COVID-19: Pitfalls and Opportunities.2019冠状病毒病期间神经肌肉疾病的康复:陷阱与机遇
Front Neurol. 2021 Feb 19;12:626319. doi: 10.3389/fneur.2021.626319. eCollection 2021.
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Evaluation of the efficacy and safety of hydroxychloroquine in comparison with chloroquine in moderate and severe patients with COVID-19.评估羟氯喹与氯喹相比在中度和重度COVID-19患者中的疗效和安全性。
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The QT interval in patients with COVID-19 treated with hydroxychloroquine and azithromycin.接受羟氯喹和阿奇霉素治疗的新冠肺炎患者的QT间期。
Nat Med. 2020 Jun;26(6):808-809. doi: 10.1038/s41591-020-0888-2.
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Hydroxychloroquine in patients with mainly mild to moderate coronavirus disease 2019: open label, randomised controlled trial.羟氯喹治疗主要为轻症和中症的 2019 冠状病毒病患者:开放标签、随机对照试验。
BMJ. 2020 May 14;369:m1849. doi: 10.1136/bmj.m1849.
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COVID-19 and off label use of drugs: an ethical viewpoint.COVID-19 与药物的标签外使用:伦理视角。
Daru. 2020 Dec;28(2):789-793. doi: 10.1007/s40199-020-00351-y. Epub 2020 May 8.
7
Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19.羟氯喹治疗 COVID-19 住院患者的观察性研究。
N Engl J Med. 2020 Jun 18;382(25):2411-2418. doi: 10.1056/NEJMoa2012410. Epub 2020 May 7.
8
Effect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Randomized Clinical Trial.高剂量与低剂量磷酸氯喹作为辅助治疗对住院的严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)感染患者的影响:一项随机临床试验。
JAMA Netw Open. 2020 Apr 24;3(4):e208857. doi: 10.1001/jamanetworkopen.2020.8857.
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Potential Effects of Coronaviruses on the Cardiovascular System: A Review.冠状病毒对心血管系统的潜在影响:综述。
JAMA Cardiol. 2020 Jul 1;5(7):831-840. doi: 10.1001/jamacardio.2020.1286.
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Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial.羟氯喹和阿奇霉素治疗 COVID-19:一项开放标签非随机临床试验的结果。
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