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聚维酮碘对鼻咽部新型冠状病毒的杀病毒作用:一项开放标签随机临床试验。

Virucidal effect of povidone iodine on COVID-19 in the nasopharynx: an open-label randomized clinical trial.

作者信息

Arefin Mostafa Kamal, Rumi S K Nurul Fattah, Uddin A K M Nasir, Banu Sultana Sahana, Khan Mala, Kaiser Ahsanul, Chowdhury Joybaer Anam, Khan Md Abdullah Saeed, Hasan Mohammad Jahid

机构信息

Dhaka Medical College Hospital, Dhaka, Bangladesh.

Bangladesh Reference Institute of Chemical Measurements (BRICM), Dhaka, Bangladesh.

出版信息

Indian J Otolaryngol Head Neck Surg. 2022 Oct;74(Suppl 2):2963-2967. doi: 10.1007/s12070-021-02616-7. Epub 2021 May 18.

Abstract

Povidone-iodine (PVP-I) is a time-tested antiseptic agent with excellent virucidal (99.99%) properties. Repurposing it against coronavirus disease-19 (COVID-19) is a relatively newer concept and has been sparsely tested in vivo. The most common route of entry of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) is the nasopharynx. Averting colonization of the virus could be one of the best options to reduce the incidence of infection. PVP-I gargle and mouthwash were found to be effective in vitro rapid inactivation against SARS-CoV-2 on a smaller scale (Hassandarvish et al. in BDJ 1-4, 2020, Pelletier et al. in ENTJ 1-5, 2020). However, efficacy in humans is lacking. To assess the virucidal effect of PVP-I against SARS-CoV-2 located in the nasopharynx was the objective of this parallel armed randomized clinical trial. We screened all RT-PCR-confirmed COVID-19 cases aged 18 years and above with symptoms. Written informed consent was obtained before randomization. Nasopharyngeal clearance of SARS-CoV-2 was tested after single time application of PVP-I nasal irrigation (NI) at diluted concentrations of .4%, .5% and .6% and PVP-I nasal spray (NS) at diluted concentrations of .5% and .6%. All groups were compared to the corresponding controls (distilled water). The primary outcome was viral clearance in a repeat RT-PCR (qualitative), and the secondary outcome was the number of adverse events. Final data analysis was performed using the statistical software SPSS (Version 20). A total of 189 confirmed COVID-19 cases were randomized into seven groups: 27 patients in each group. Of all, 159 (84.1%) were male, and 30 (15.9%) were female. We observed a statistically significant proportion of nasopharyngeal clearance with all strengths of PVP-I NI and PVP-I NS compared to the corresponding controlsAdditionally, 0.5% NI was significantly better than 0.5% NS for viral clearance ( = 0.018) and had the highest nasopharyngeal clearance among all strengths (n = 25, 92.6%). 0.6% NS is better than CNS and 0.5%NS in viral clearance. The only adverse event was nasal irritation recorded in two patients each in the 0.4% and 0.6% PVP-I NI groups (Tables 1 and 2). PVP-I NI and NS are proved as effective virucidal agent against SARS-CoV-2 in human body. Our recommendation is to use PVP-I in naopharynx (as well as oropharynx) to prevent COVID-19.

摘要

聚维酮碘(PVP-I)是一种经过时间考验的消毒剂,具有出色的杀病毒(99.99%)特性。将其用于对抗冠状病毒病-19(COVID-19)是一个相对较新的概念,且在体内的测试较少。严重急性呼吸综合征冠状病毒2(SARS-CoV-2)最常见的进入途径是鼻咽部。避免病毒定植可能是降低感染发生率的最佳选择之一。研究发现,PVP-I漱口水和漱口液在较小规模上对SARS-CoV-2具有有效的体外快速灭活作用(Hassandarvish等人,《英国牙科杂志》1 - 4,2020年;Pelletier等人,《耳鼻喉科杂志》1 - 5,2020年)。然而,其对人体的疗效尚缺乏研究。本平行双臂随机临床试验的目的是评估PVP-I对位于鼻咽部的SARS-CoV-2的杀病毒效果。我们筛选了所有年龄在18岁及以上且有症状的RT-PCR确诊COVID-19病例。在随机分组前获得了书面知情同意书。在单次应用稀释浓度为0.4%、0.5%和0.6%的PVP-I鼻腔冲洗液(NI)以及稀释浓度为0.5%和0.6%的PVP-I鼻腔喷雾剂(NS)后,检测SARS-CoV-2的鼻咽清除情况。所有组均与相应对照组(蒸馏水)进行比较。主要结局是重复RT-PCR(定性)中的病毒清除情况,次要结局是不良事件的数量。使用统计软件SPSS(版本20)进行最终数据分析。共有189例确诊的COVID-19病例被随机分为七组:每组27例患者。其中,159例(84.1%)为男性,30例(15.9%)为女性。与相应对照组相比,我们观察到所有浓度的PVP-I NI和PVP-I NS在鼻咽清除方面均有统计学意义上的显著比例。此外,0.5%的NI在病毒清除方面显著优于0.5%的NS(P = 0.018),且在所有浓度中鼻咽清除率最高(n = 25,92.6%)。0.6%的NS在病毒清除方面优于中枢神经系统和0.5%的NS。唯一的不良事件是在0.4%和0.6%的PVP-I NI组中各有两名患者出现鼻腔刺激(表1和表2)。PVP-I NI和NS被证明是针对人体中SARS-CoV-2的有效杀病毒剂。我们的建议是在鼻咽部(以及口咽部)使用PVP-I来预防COVID-19。

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