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使用局部聚维酮碘后新型冠状病毒逆转录聚合酶链反应循环阈值的变化:一项单臂开放标签干预性研究。

Changes in reverse transcription polymerase chain reaction cycle threshold values of SARS-CoV-2 with topical povidone iodine use: A single-arm open-label interventional study.

作者信息

Shankar Sumita, Jamir Limalemla, Kakkar Rakesh, Babji Korukonda, Mangayarkarasi V, Tripathi Mukesh, Tak Heena

机构信息

Department of Plastic Surgery, Rangaraya Medical College, Kakinada, Andhra Pradesh, India.

Department of Community and Family Medicine, All India Institute of Medical Sciences, (AIIMS), Mangalagiri, Andhra Pradesh, India.

出版信息

J Family Med Prim Care. 2022 Feb;11(2):480-486. doi: 10.4103/jfmpc.jfmpc_993_21. Epub 2022 Feb 16.

DOI:10.4103/jfmpc.jfmpc_993_21
PMID:35360801
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8963622/
Abstract

CONTEXT

Repurposed povidone iodine (PVP-I) has been suggested as an effective adjuvant against coronavirus disease-2019 (COVID-19).

AIM

The aim of this study was to assess the changes in RT-PCR cycle threshold (Ct) values of severe acute respiratory Syndrome Coronavirus-2 (SARS-CoV-2) genes with PVP-I intranasal and oral application.

SETTINGS AND DESIGN

A longitudinal (repeated measures) single-arm open-label interventional study was conducted for 200 samples of ten COVID-19 patients in South India.

METHODS AND MATERIAL

Demographic and clinical information were collected. Intranasal application and oral gargle with 1% PVP-I solution was done four times a day for seven days. Nasopharyngeal and oropharyngeal samples were taken for RT-PCR test at hour-0, hour-2, hour-4 on Day-0, Day-3, Day-6, and hour-0 on Day-9.

METHODS AND MATERIAL

STATA analysis software version 14.2 was used. McNemar Test was applied for paired samples. Skilling Mack Test was used to assess the association between PVP-I use (intra-day and inter-day) and / Ct values. Pearson correlation coefficients and Bland-Altman plots were used for further analyses.

RESULTS

Mean (SD) age of the patients was 41.5 (±8.82) years. A total of 100 pairs of nasopharyngeal and oropharyngeal samples were analysed. No significant difference was observed in the Ct values of asymptomatic and symptomatic patients. Ct values (nasopharyngeal) at Hour-0 increased from Day-0 to Day-9 ( = 0.005). Ct value was higher at Hour-2 for most of the samples.

CONCLUSIONS

RT-PCR results (qualitative) differed at various testing points in the same patients. Lower Ct values were found in the nasopharyngeal samples. Successive increase in Ct values indicates reduced viral load with natural course of COVID-19. PVP-I may have an optimal impact within 2 h of usage.

CLINICAL TRIAL REGISTRATION NUMBER

CTRI/2020/05/024962.

摘要

背景

有人提出,重新利用的聚维酮碘(PVP-I)可作为对抗2019冠状病毒病(COVID-19)的有效佐剂。

目的

本研究的目的是评估严重急性呼吸综合征冠状病毒2(SARS-CoV-2)基因的逆转录聚合酶链反应(RT-PCR)循环阈值(Ct)值在经鼻和口服PVP-I后的变化。

设置与设计

对印度南部10名COVID-19患者的200份样本进行了一项纵向(重复测量)单臂开放标签干预研究。

方法与材料

收集人口统计学和临床信息。每天用1% PVP-I溶液进行4次经鼻给药和口腔含漱,持续7天。在第0天、第3天、第6天的第0小时、第2小时、第4小时以及第9天的第0小时采集鼻咽和口咽样本进行RT-PCR检测。

方法与材料

使用STATA分析软件版本14.2。对配对样本应用McNemar检验。使用Skilling Mack检验评估PVP-I使用(日内和日间)与/Ct值之间的关联。使用Pearson相关系数和Bland-Altman图进行进一步分析。

结果

患者的平均(标准差)年龄为41.5(±8.82)岁。共分析了100对鼻咽和口咽样本。无症状和有症状患者的Ct值未观察到显著差异。第0小时(鼻咽)的Ct值从第0天到第9天有所增加(=0.005)。大多数样本在第2小时的Ct值较高。

结论

同一患者在不同检测点的RT-PCR结果(定性)不同。鼻咽样本中发现较低的Ct值。Ct值连续增加表明COVID-19自然病程中病毒载量降低。PVP-I可能在使用后2小时内产生最佳效果。

临床试验注册号

CTRI/2020/05/024962。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d24/8963622/e55fb0cba944/JFMPC-11-480-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d24/8963622/d91a4ac53f82/JFMPC-11-480-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d24/8963622/e55fb0cba944/JFMPC-11-480-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d24/8963622/d91a4ac53f82/JFMPC-11-480-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d24/8963622/e55fb0cba944/JFMPC-11-480-g002.jpg

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