连花清瘟片治疗长冠状病毒病(COVID)咳嗽的有效性和安全性:一项随机、双盲、安慰剂对照的多中心临床研究

IF 10.1 1区 工程技术 Q1 ENGINEERING, MULTIDISCIPLINARY Engineering Pub Date : 2024-09-01 DOI:10.1016/j.eng.2024.03.013
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引用次数: 0

摘要

连花清瘟片是一种专利中药,对治疗严重急性呼吸系统综合征冠状病毒 2 型感染引起的咳嗽有确切的临床疗效,但缺乏严格的循证研究来评估其对长程冠状病毒病(COVID)咳嗽的疗效。一项随机、双盲、安慰剂对照的多中心临床研究在中国 19 家医院和 23 家社区卫生中心的长征冠状病毒病咳嗽患者中展开。患者按 1:1 的比例随机接受连花清瘟片或安慰剂口服治疗 14 天(4 片,1.84 克,每天 3 次)。主要终点指标是咳嗽消失,咳嗽缓解也在考虑之列。在 482 名随机患者中,480 人(全面分析组 480 人;按协议组 470 人;安全组 480 人)被纳入主要分析。根据全面分析,试验组咳嗽消失的时间明显短于对照组,14 天咳嗽消失率显著增加。相应地,试验组的咳嗽缓解时间也明显短于对照组。在第 7 天和第 14 天,试验组症状总分的变化明显大于对照组,这与视觉模拟量表(VAS)和咳嗽评估测试(CET)评分显示的结果一致。研究期间未出现严重不良反应。连花清瘟片能明显改善COVID久咳患者的临床症状。
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Efficacy and Safety of Lianhua Qingke Tablets in the Treatment of Long Coronavirus Disease (COVID) Cough: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study

Lianhua Qingke tablets, a patented traditional Chinese medicine that has validated clinical efficacy for treating cough caused by severe acute respiratory syndrome coronavirus 2 infection, lack rigorous evidence-based research evaluating their effect on long coronavirus disease (COVID) cough. A randomized, double-blind, placebo-controlled, multicenter clinical study was conducted among patients with long COVID cough from 19 hospitals and 23 community health centers in China. Patients were randomized 1:1 to receive either Lianhua Qingke tablets or placebo orally for 14 days (four tablets, 1.84 g, three times a day). The primary endpoint indicator was the disappearance of cough, with the remission of cough also considered. Among 482 randomized patients, 480 (full analysis set 480; per-protocol set 470; safety set 480) were included in the primary analysis. According to the full analysis, the time until cough disappearance was significantly shorter in the trial group than in the control group, with a significant increase in the 14-day cough disappearance rate. Accordingly, the time to cough remission was significantly shorter in the trial group than in the control group. The change in the total symptom score was significantly greater in the trial group than in the control group on days 7 and 14, consistent with the results indicated by the visual analog scale (VAS) and cough evaluation test (CET) scores. No serious adverse events were recorded during the study. Lianhua Qingke tablets significantly improved the clinical symptoms of patients with long COVID cough.

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来源期刊
Engineering
Engineering Environmental Science-Environmental Engineering
自引率
1.60%
发文量
335
审稿时长
35 days
期刊介绍: Engineering, an international open-access journal initiated by the Chinese Academy of Engineering (CAE) in 2015, serves as a distinguished platform for disseminating cutting-edge advancements in engineering R&D, sharing major research outputs, and highlighting key achievements worldwide. The journal's objectives encompass reporting progress in engineering science, fostering discussions on hot topics, addressing areas of interest, challenges, and prospects in engineering development, while considering human and environmental well-being and ethics in engineering. It aims to inspire breakthroughs and innovations with profound economic and social significance, propelling them to advanced international standards and transforming them into a new productive force. Ultimately, this endeavor seeks to bring about positive changes globally, benefit humanity, and shape a new future.
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