一项多中心、随机、开放标签、安慰剂对照临床试验：西乙吡啶氯化铵（cpc）漱口水和按需二氧化氯水溶液漱口水对轻度柯维-19 患者沙士-柯维-2 病毒滴度的影响

IF 4.1 4区医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE Journal of Evidence-Based Dental Practice Pub Date : 2024-09-17 DOI:10.1016/j.jebdp.2024.102040

DAISUKE ONOZUKA PhD , KEIJI KONISHI MD , SATOKO TAKATERA PhD , MASAHIDE OSAKI MD , SHOUGEN SUMIYOSHI MD , YUSUKE TAKAHASHI MD , SHIGETO HAMAGUCHI MD, PhD , YASUO IMOTO PhD , SATOSHI KUTSUNA MD, PhD

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引用次数: 0

摘要

目的西吡啶氯化物（CPC）漱口水对 SARS-CoV-2 病毒滴度的影响尚不明确。方法在这项多中心、三组、随机、开放标签、安慰剂对照临床试验中，我们将轻度症状的 COVID-19 患者随机分配到 20 mL 0.05% CPC、10 mL 0.01% 按需二氧化氯水溶液或 20 mL 纯净水作为安慰剂，比例为 1:1:1。结果49 名患者在 2024 年 1 月 14 日至 2024 年 2 月 20 日期间接受了 CPC 漱口水（16 人）、按需二氧化氯水漱口水（16 人）和安慰剂（17 人）。使用后 10 分钟，0.05% CPC 漱口水可显著降低唾液病毒滴度（-0.97 log10 PFU/mL；95% CI，-1.64 至-0.30；P = .004），而 30 分钟后则未观察到此类效果（与安慰剂相比，差异为-0.26 log10 PFU/mL；95% CI，-0.92 至 0.40；P = .435）或 60 分钟（与安慰剂相比，差异为 -0.05 log10 PFU/mL；95% CI，-0.68 至 0.58；P = .877）。结论使用 0.05% CPC 漱口水 10 分钟后，SARS-CoV-2 的唾液病毒滴度与安慰剂相比有所下降。试验注册日本临床试验注册中心（jRCT）：jRCTs031230566.

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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

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 log₁₀ 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 log₁₀ PFU/mL; 95% CI, -0.92 to 0.40; P = .435) or 60 minutes (difference vs. placebo, -0.05 log₁₀ 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.

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来源期刊

Journal of Evidence-Based Dental Practice DENTISTRY, ORAL SURGERY & MEDICINE-

CiteScore

6.00

自引率

16.70%

发文量

105

审稿时长

28 days

期刊介绍： The Journal of Evidence-Based Dental Practice presents timely original articles, as well as reviews of articles on the results and outcomes of clinical procedures and treatment. The Journal advocates the use or rejection of a procedure based on solid, clinical evidence found in literature. The Journal''s dynamic operating principles are explicitness in process and objectives, publication of the highest-quality reviews and original articles, and an emphasis on objectivity.