医学
喉咙痛
临床终点
随机对照试验
安慰剂
肌痛
临床试验
不利影响
置信区间
寒冷
内科学
中期分析
外科
病理
替代医学
作者
Jinping Zheng,Yun Ling,L. L. Jiang,Piroon Mootsikapun,Hongzhou Lu,Methee Chayakulkeeree,Lixiu Zhang,Pureepat Arttawejkul,Fengyu Hu,Thérèse Truong,Roxan A. Perez,Xing Gu,Huimin Sun,Jun Jiang,Renjie Liu,Ding Zhang,Yangqing Zhan,Zifeng Yang,Weijun Guan,Nanshan Zhong
标识
DOI:10.1186/s12985-023-02144-6
摘要
Abstract Background In a randomized trial, Lianhuaqingwen (LHQW) capsule was effective for accelerating symptom recovery among patients with coronavirus disease 2019 (COVID-19). However, the lack of blinding and limited sample sizes decreased the level of clinical evidence. Objectives To evaluate the efficacy and safety of LHQW capsule in adults with mild-to-moderate COVID-19. Methods We conducted a double-blind randomized controlled trial in adults with mild-to-moderate COVID-19 (17 sites from China, Thailand, Philippine and Vietnam). Patients received standard-of-care alone or plus LHQW capsules (4 capsules, thrice daily) for 14 days. The primary endpoint was the median time to sustained clinical improvement or resolution of nine major symptoms. Results The full-analysis set consisted of 410 patients in LHQW capsules and 405 in placebo group. LHQW significantly shortened the primary endpoint in the full-analysis set (4.0 vs. 6.7 days, hazards ratio: 1.63, 95% confidence interval: 1.39-1.90). LHQW capsules shortened the median time to sustained clinical improvement or resolution of stuffy or runny nose (2.8 vs. 3.7 days), sore throat (2.0 vs. 2.6 days), cough (3.2 vs. 4.9 days), feeling hot or feverish (1.0 vs. 1.3 days), low energy or tiredness (1.3 vs. 1.9 days), and myalgia (1.5 vs. 2.0 days). The duration to sustained clinical improvement or resolution of shortness of breath, headache, and chills or shivering did not differ significantly between the two groups. Safety was comparable between the two groups. No serious adverse events were reported. Interpretation LHQW capsules promote recovery of mild-to-moderate COVID-19 via accelerating symptom resolution and were well tolerated. Trial registration ChiCTR2200056727 .
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