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一项关于十六烷基氯化吡啶(CPC)漱口水和按需使用的二氧化氯水溶液漱口水对轻度新冠肺炎患者新冠病毒2型(SARS-CoV-2)病毒载量影响的多中心、随机、开放标签、安慰剂对照临床试验。

A MULTICENTER, RANDOMIZED, OPEN-LABEL, PLACEBO-CONTROLLED CLINICAL TRIAL OF THE EFFECT OF CETYLPYRIDINIUM CHLORIDE (CPC) MOUTHWASH AND ON-DEMAND AQUEOUS CHLORINE DIOXIDE MOUTHWASH ON SARS-COV-2 VIRAL TITER IN PATIENTS WITH MILD COVID-19.

作者信息

Onozuka Daisuke, Konishi Keiji, Takatera Satoko, Osaki Masahide, Sumiyoshi Shougen, Takahashi Yusuke, Hamaguchi Shigeto, Imoto Yasuo, Kutsuna Satoshi

机构信息

Department of Oral Microbe Control, Graduate School of Medicine, Osaka University, Osaka, Japan; Department of Infection Control and Prevention, Graduate School of Medicine, Osaka University, Osaka, Japan.

Department of Oral Microbe Control, Graduate School of Medicine, Osaka University, Osaka, Japan; Department of Infection Control and Prevention, Graduate School of Medicine, Osaka University, Osaka, Japan.

出版信息

J Evid Based Dent Pract. 2024 Dec;24(4):102040. doi: 10.1016/j.jebdp.2024.102040. Epub 2024 Sep 17.

DOI:10.1016/j.jebdp.2024.102040
PMID:39631972
Abstract

OBJECTIVES

The established effect of cetylpyridinium chloride (CPC) mouthwash on SARS-CoV-2 viral titers is unclear. No clinical trial has examined the impact of on-demand aqueous chlorine dioxide mouthwash on SARS-CoV-2 viral titer.

METHODS

In this multicenter, 3-armed, randomized, open-label, placebo-controlled clinical trial involving mildly symptomatic COVID-19 patients, we randomly assigned them to receive 20 mL of 0.05% CPC, 10 mL of 0.01% on-demand aqueous chlorine dioxide, or 20 mL of purified water as a placebo mouthwash in a 1:1:1 ratio. The primary measurement was the SARS-CoV-2 viral titer in saliva, evaluated by a mixed-effects linear regression model.

RESULTS

49 patients received CPC mouthwash (n=16), on-demand aqueous chlorine dioxide mouthwash (n=16), and placebo (n=17) between January 14, 2024, and February 20, 2024. 0.05% CPC mouthwash significantly reduced salivary viral titer at 10 minutes postuse (-0.97 log PFU/mL; 95% CI, -1.64 to -0.30; P = .004), while no such effect was observed at 30 minutes (difference vs placebo, -0.26 log PFU/mL; 95% CI, -0.92 to 0.40; P = .435) or 60 minutes (difference vs. placebo, -0.05 log PFU/mL; 95% CI, -0.68 to 0.58; P = .877). 0.01% on-demand chlorine dioxide mouthwash did not reduce salivary viral titer at 10 minutes, 30 minutes, or 60 minutes compared to placebo.

CONCLUSIONS

10 minutes after using a 0.05% CPC mouthwash, the salivary viral titer of SARS-CoV-2 decreased compared to placebo. 0.01% on-demand aqueous chlorine dioxide mouthwash and placebo had no significant difference in SARS-CoV-2 viral titers.

TRIAL REGISTRATION

Japan Registry of Clinical Trials (jRCT): jRCTs031230566.

摘要

目的

西吡氯铵(CPC)漱口水对严重急性呼吸综合征冠状病毒2(SARS-CoV-2)病毒滴度的既定影响尚不清楚。尚无临床试验研究按需使用的二氧化氯漱口水对SARS-CoV-2病毒滴度的影响。

方法

在这项多中心、三臂、随机、开放标签、安慰剂对照的临床试验中,我们纳入了症状较轻的2019冠状病毒病(COVID-19)患者,并将他们按1:1:1的比例随机分配,分别接受20毫升0.05%的CPC、10毫升0.01%的按需使用的二氧化氯水溶液或20毫升纯化水作为安慰剂漱口水。主要测量指标是唾液中的SARS-CoV-2病毒滴度,采用混合效应线性回归模型进行评估。

结果

在2024年1月14日至2024年2月20日期间,49例患者分别接受了CPC漱口水(n = 16)、按需使用的二氧化氯漱口水(n = 16)和安慰剂(n = 17)。使用0.05%的CPC漱口水后10分钟,唾液病毒滴度显著降低(-0.97 log PFU/mL;95%置信区间,-1.64至-0.30;P = 0.004),而在30分钟时未观察到这种效果(与安慰剂相比的差异,-0.26 log PFU/mL;95%置信区间,-0.92至0.40;P = 0.435),60分钟时也未观察到(与安慰剂相比的差异,-0.05 log PFU/mL;95%置信区间,-0.68至0.58;P = 0.877)。与安慰剂相比,0.01%的按需使用的二氧化氯漱口水在10分钟、30分钟或60分钟时均未降低唾液病毒滴度。

结论

使用0.05%的CPC漱口水10分钟后,与安慰剂相比,SARS-CoV-2的唾液病毒滴度降低。0.01%的按需使用的二氧化氯漱口水与安慰剂在SARS-CoV-2病毒滴度上无显著差异。

试验注册

日本临床试验注册中心(jRCT):jRCTs031230566 。

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