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撤回关于 SARS-CoV-2 感染的临床试验:一个未解决的问题及其对冠状病毒病 (COVID-19) 治疗的可能影响。

Retraction of Clinical Trials about the SARS-CoV-2 Infection: An Unaddressed Problem and Its Possible Impact on Coronavirus Disease (COVID)-19 Treatment.

机构信息

Laboratory of Cell and Molecular Tumor Biology and Bioactive Compounds, São Francisco University, Bragança Paulista 12916-900, SP, Brazil.

Laboratory of Human and Medical Genetics, São Francisco University, Bragança Paulista 12916-900, SP, Brazil.

出版信息

Int J Environ Res Public Health. 2023 Jan 19;20(3):1835. doi: 10.3390/ijerph20031835.

Abstract

We are presenting an overview of the retracted clinical trials about the Coronavirus Disease (COVID)-19 published in PubMed using the descriptors ((COVID-19 OR SARS-CoV-2) AND (Clinical Trial)). We collected the information for i) the first author's country; ii) the journal name where the study was published; iii) the impact factor of the journal; iv) the main objective of the study; v) methods including population, intervention, study design, and outcomes; and vi) results and conclusions. We collected complete information from the retraction notes published by the journals and the number of publications/retractions related to non-COVID-19 clinical trials published simultaneously. We also included the Altmetric index for the clinical trials and the retraction notes about COVID-19 to compare the accessibility to both studies' indexes. The retraction of clinical trials occurred in four countries (one in Lebanon, one in India, one in Brazil, and five in Egypt) and six journals (one in Viruses, one in Archives of Virology, one in Expert Review of Anti-infective Therapy, one in Frontiers in Medicine, two in Scientific Reports, and two in The American Journal of Tropical Medicine and Hygiene). Eight drugs were tested (Ivermectin, Vitamin D, Proxalutamide, Hydroxychloroquine, Remdesevir, Favipiravir, and Sofosbuvir + Daclatasvir) in the studies. One of the retractions was suggested by the authors due to an error in the statistical analysis, which compromised their results and conclusions. Also, the methods, mainly the allocation, were not well conducted in the two studies, and the studies were retracted. In addition, the studies performed by Dabbous et al. presented several issues, mainly including several raw datasets that did not prove their findings. Moreover, two studies were retracted due to data overlap and copying. Significant concerns were raised about the integrity of the data and reported results in another article. We identified a higher Altmetric index for the original studies, proving that the retracted studies were accessed more than the retraction notes. Interestingly, the impact of the original articles is much higher than their retraction notes. The different Altmetric indexes show that possibly people who read those retracted articles are not reading their retraction notes and are unaware of the erroneous information they share. COVID-19- related clinical trials were ~two-time times more retracted than the other clinical trials performed during the same time.

摘要

我们概述了在 PubMed 中使用描述符((COVID-19 或 SARS-CoV-2)和(临床试验))检索到的已撤回的关于冠状病毒病(COVID-19)的临床研究。我们收集了以下信息:i)第一作者所在国家;ii)研究发表的期刊名称;iii)期刊的影响因子;iv)研究的主要目标;v)方法,包括人群、干预、研究设计和结果;以及 vi)结果和结论。我们从期刊发表的撤回说明中收集了完整的信息,并同时收集了与非 COVID-19 临床试验相关的出版物/撤回数量。我们还包括临床试验和 COVID-19 撤回说明的 Altmetric 指数,以比较这两项研究的可访问性指数。临床试验的撤回发生在四个国家(黎巴嫩、印度、巴西各一起,埃及五起)和六个期刊(病毒学杂志、病毒学档案杂志、抗感染治疗专家评论杂志、医学前沿杂志、科学报告杂志各一起,美国热带医学与卫生杂志两起)。研究中测试了八种药物(伊维菌素、维生素 D、普罗沙尔酰胺、羟氯喹、瑞德西韦、法匹拉韦和索非布韦+达卡他韦)。其中一项撤回是由于作者在统计分析中犯了一个错误,导致结果和结论不可靠,因此建议撤回。此外,两项研究的方法,主要是分配,做得不好,因此也被撤回。此外,Dabbous 等人的研究存在一些问题,主要包括一些没有证明其发现的原始数据集。此外,由于数据重叠和复制,两项研究被撤回。另一篇文章对数据和报告结果的完整性提出了重大质疑。我们发现原始研究的 Altmetric 指数较高,证明撤回的研究比撤回说明更受关注。有趣的是,原始文章的影响远高于其撤回说明。不同的 Altmetric 指数表明,阅读这些撤回文章的人可能没有阅读他们的撤回说明,也不知道他们分享的错误信息。与其他同时进行的临床试验相比,与 COVID-19 相关的临床试验被撤回的比例约高两倍。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afe1/9914919/3183217f295d/ijerph-20-01835-g001.jpg

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