Toumi Mondher, Biernikiewicz Malgorzata, Liang Shuyao, Wang Yitong, Qiu Tingting, Han Ru
Department of Public Health, Aix-Marseille University, Marseille, France.
Medical Writing and Publishing, Creativ-Ceutical, Krakow, Poland.
J Mark Access Health Policy. 2020 Sep 10;8(1):1809236. doi: 10.1080/20016689.2020.1809236.
A international registry analysis led by Mehra et al. to investigate the use of hydroxychloroquine (HCQ) and chloroquine (CQ) with or without a macrolide in 96,032 hospitalised COVID-19 patients were published on Lancet, which has raised considerable discussions in the public health community. This study aimed to critically review the quality and limitations of the Mehra et al. publication and discuss the potential influences on the use of HCQ/CQ worldwide. A critical review of this publication was conducted to examine the potential study bias in the study objectives, methodology, confounding factors and outcomes and summarise the external reviews. The very high homogeneity of the patients' characteristics at baseline was inconsistent with region specific epidemiology and several critical confounding factors. The results indicated that angiotensin converting enzyme inhibitors were associated with a hazard ratio of 0.5, which suggested a technical problem in the estimation of the propensity scores. Several major risk factors for mortality identified in the analysis were treated as a minor risk or neutral or even protective factors. Antiviral treatments were recognised as an effective method to reduce mortality and were neither further studied nor integrated in the multivariate Cox model. This research appeared to carry multiple biases. An extensive audit of the study, conditions of review and acceptance for publication in the Lancet of that study are requested to avoid damage to the publics' trust on the scientific community at this critical time of COVID-19 pandemic.
由梅赫拉等人牵头的一项国际注册研究分析了96032名住院的COVID-19患者使用羟氯喹（HCQ）和氯喹（CQ）加或不加大环内酯类药物的情况，该研究发表在《柳叶刀》上，在公共卫生界引发了相当多的讨论。本研究旨在严格审查梅赫拉等人发表文章的质量和局限性，并讨论其对全球HCQ/CQ使用的潜在影响。对该出版物进行了严格审查，以检查研究目标、方法、混杂因素和结果中潜在的研究偏差，并总结外部评论。患者基线特征的高度同质性与特定地区的流行病学以及几个关键的混杂因素不一致。结果表明，血管紧张素转换酶抑制剂的风险比为0.5，这表明在倾向评分估计中存在技术问题。分析中确定的几个主要死亡风险因素被视为次要风险、中性风险甚至保护因素。抗病毒治疗被认为是降低死亡率的有效方法，但既未进一步研究，也未纳入多变量Cox模型。这项研究似乎存在多种偏差。要求对该研究、审查条件以及该研究在《柳叶刀》上发表的接受情况进行广泛审查，以避免在COVID-19大流行的这个关键时刻损害公众对科学界的信任。
