Efficacy and safety of Lianhuaqingwen capsules, a repurposed Chinese herb, in patients with coronavirus disease 2019: A multicenter, prospective, randomized controlled trial

医学 随机对照试验 不利影响 内科学 临床终点 前瞻性队列研究 临床试验 外科 胃肠病学
作者
Ke Hu,Wei‐jie Guan,Ying Bi,Wei Zhang,Lanjuan Li,Boli Zhang,Qingquan Liu,Yuanlin Song,Xingwang Li,Zhongping Duan,Qingshan Zheng,Zifeng Yang,Jingyi Liang,Mingfeng Han,Lianguo Ruan,Chaomin Wu,Yunting Zhang,Zhenhua Jia,Nanshan Zhong
出处
期刊:Phytomedicine [Elsevier]
卷期号:85: 153242-153242 被引量:370
标识
DOI:10.1016/j.phymed.2020.153242
摘要

Coronavirus disease 2019 (Covid-19) has resulted in a global outbreak. Few existing targeted medications are available. Lianhuaqingwen (LH) capsule, a repurposed marketed Chinese herb product, has been proven effective for influenza.To determine the safety and efficacy of LH capsule in patients with Covid-19.We did a prospective multicenter open-label randomized controlled trial on LH capsule in confirmed cases with Covid-19. Patients were randomized to receive usual treatment alone or in combination with LH capsules (4 capsules, thrice daily) for 14 days. The primary endpoint was the rate of symptom (fever, fatigue, coughing) recovery.We included 284 patients (142 each in treatment and control group) in the full-analysis set. The recovery rate was significantly higher in treatment group as compared with control group (91.5% vs. 82.4%, p = 0.022). The median time to symptom recovery was markedly shorter in treatment group (median: 7 vs. 10 days, p < 0.001). Time to recovery of fever (2 vs. 3 days), fatigue (3 vs. 6 days) and coughing (7 vs. 10 days) was also significantly shorter in treatment group (all p < 0.001). The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%, p < 0.001) and clinical cure (78.9% vs. 66.2%, p = 0.017) was also higher in treatment group. However, both groups did not differ in the rate of conversion to severe cases or viral assay findings (both p > 0.05). No serious adverse events were reported.In light of the safety and effectiveness profiles, LH capsules could be considered to ameliorate clinical symptoms of Covid-19.
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