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连花清瘟胶囊治疗无症状 COVID-19 患者的有效性:一项随机、对照、多中心试验。

Effectiveness of Lianhua Qingwen Capsule in Treatment of Asymptomatic COVID-19 Patients: A Randomized, Controlled Multicenter Trial.

机构信息

Respiratory Department, Hebei Chest Hospital, Shijiazhuang, P.R. China.

Respiratory Department, Hebei Hospital of Traditional Chinese Medicine, Shijiazhuang, P.R. China.

出版信息

J Integr Complement Med. 2022 Nov;28(11):887-894. doi: 10.1089/jicm.2021.0352. Epub 2022 Nov 4.

DOI:10.1089/jicm.2021.0352
PMID:36342811
Abstract

Asymptomatic patients are unneglected sources in propagating transmission chain due to their high viral loads. However, treatments available based on symptoms seem not applicable to asymptomatic patients. In this study, the authors want to estimate the effectiveness of Lianhua Qingwen (LH) capsule on asymptomatic coronavirus disease 2019 (COVID-19) patients. A randomized controlled trial (RCT) was performed to explore the effectiveness and safety of LH capsule in treating asymptomatic COVID-19 patients. Patients were randomized to control group (isolated observation) and treatment group (LH, 4 capsules, thrice daily) for 14 days. The primary endpoints were the rate and time of nucleic acid turning negative during the isolation observation. A total of 120 participants were included in the full analysis set (60 each in the control and treatment groups). Data showed that the rate of nucleic acid turning negative during the isolation observation in the treatment group was higher than that in the control group (rate difference: 21.66%, 95% confidence interval [CI]: 4.34 to 37.27,  = 0.0142). Patients in the treatment group have a shorter time of nucleic acid turning negative (7.5 vs. 14.5 days,  = 0.018). Moreover, the rate of clinical symptoms appearance in the treatment group was lower compared with that in the control group (rate difference: -31.67, 95% CI: -46.83 to -13.82,  = 0.0005). The proportion of confirmed mild and common cases in the treatment group was also lower (35.00% vs. 66.67%,  = 0.0005). No serious adverse events were documented. In this study, the authors illustrated that LH capsule is beneficial to asymptomatic COVID-19 patients. Considering the lack of interventions for treating asymptomatic COVID-19 patients at this stage, LH capsule could be considered as a choice. ChiCTR2100042066.

摘要

无症状患者由于病毒载量高,成为传播链中不可忽视的传染源。然而,基于症状的治疗方法似乎不适用于无症状患者。本研究旨在评估连花清瘟胶囊对无症状新型冠状病毒肺炎(COVID-19)患者的疗效。一项随机对照试验(RCT)评估了连花清瘟胶囊治疗无症状 COVID-19 患者的有效性和安全性。患者随机分为对照组(隔离观察)和治疗组(连花清瘟胶囊,4 粒,每日 3 次),疗程 14 天。主要终点为隔离观察期间核酸转阴率和时间。共有 120 名患者纳入全分析集(对照组和治疗组各 60 例)。数据显示,治疗组隔离观察期间核酸转阴率高于对照组(转阴率差值:21.66%,95%置信区间 [CI]:4.34 至 37.27, = 0.0142)。治疗组核酸转阴时间更短(7.5 天比 14.5 天, = 0.018)。此外,治疗组临床症状出现率低于对照组(症状出现率差值:-31.67%,95%CI:-46.83 至-13.82, = 0.0005)。治疗组确诊轻症和普通型病例比例也较低(35.00%比 66.67%, = 0.0005)。未发生严重不良事件。本研究表明,连花清瘟胶囊对无症状 COVID-19 患者有益。考虑到现阶段缺乏针对无症状 COVID-19 患者的干预措施,连花清瘟胶囊可作为一种选择。ChiCTR2100042066。

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