连花清瘟胶囊治疗新型冠状病毒肺炎有效性和安全性的多中心前瞻性随机对照临床试验

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

机构信息

Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong Road No. 99, Wuhan 430060, Hubei province, China.

State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province, 510120 PR China.

出版信息

Phytomedicine. 2021 May;85:153242. doi: 10.1016/j.phymed.2020.153242. Epub 2020 May 16.

DOI:10.1016/j.phymed.2020.153242

PMID:33867046

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7229744/

Abstract

BACKGROUND

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.

PURPOSE

To determine the safety and efficacy of LH capsule in patients with Covid-19.

METHODS

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.

RESULTS

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.

CONCLUSION

In light of the safety and effectiveness profiles, LH capsules could be considered to ameliorate clinical symptoms of Covid-19.

摘要

背景

2019 年冠状病毒病（Covid-19）在全球范围内爆发。目前可用的针对性药物很少。连花清瘟（LH）胶囊是一种已上市的中药产品，已被证明对流感有效。

目的

确定 LH 胶囊在 Covid-19 患者中的安全性和疗效。

方法

我们对 LH 胶囊治疗确诊的 Covid-19 患者进行了前瞻性多中心开放标签随机对照试验。患者随机接受常规治疗或常规治疗加 LH 胶囊（4 粒，每日 3 次）治疗 14 天。主要终点是症状（发热、乏力、咳嗽）恢复率。

结果

我们将 284 例患者（每组 142 例）纳入全分析集。治疗组的恢复率明显高于对照组（91.5%比 82.4%，p=0.022）。治疗组症状恢复的中位时间明显缩短（中位数：7 天比 10 天，p<0.001）。发热（2 天比 3 天）、乏力（3 天比 6 天）和咳嗽（7 天比 10 天）恢复时间也明显缩短（均 p<0.001）。治疗组胸部 CT 表现改善率（83.8%比 64.1%，p<0.001）和临床治愈率（78.9%比 66.2%，p=0.017）也更高。但两组严重病例转化率或病毒检测结果无差异（均 p>0.05）。未报告严重不良事件。