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, postcode, PR China.
Kunming University of Science and Technology Library, Kunming, China.
J Ethnopharmacol. 2021 Oct 28;279:114367. doi: 10.1016/j.jep.2021.114367. Epub 2021 Jun 24.
Although the rapid emergence of coronavirus disease 2019 (COVID-19) poses a considerable threat to global public health, no specific treatment is available for COVID-19. ReDuNing injection (RDN) is a traditional Chinese medicine known to exert antibacterial, antiviral, antipyretic, and anti-inflammatory effects. In addition, RDN has been recommended in the diagnosis and treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-associated pneumonia by the National Health Council and the National Administration of Chinese Medicine. However, there is no information regarding its efficacy against COVID-19.
This study was designed to determine the clinical efficacy of RDN in patients with COVID-19 and characterize its antiviral activity against SARS-CoV-2 in vitro.
A total of 50 adults with COVID-19 were included in this study, and the primary endpoint was recovery from clinical symptoms following 14 days of treatment. General improvements were defined as the disappearance of the major symptoms of infection including fever, fatigue, and cough. The secondary endpoints included the proportion of patients who achieved clinical symptom amelioration on days 7 and 10, time to clinical recovery, time to a negative nucleic acid test result, duration of hospitalization, and time to defervescence. Plaque reduction and cytopathic effect assays were also performed in vitro, and reverse-transcription quantitative PCR was performed to evaluate the expression of inflammatory cytokines (TNF-α, IP-10, MCP-1, IL-6, IFN-α, IFN-γ, IL-2 and CCL-5) during SARS-CoV-2 infection.
The RDN group exhibited a shorter median time for the resolution of clinical symptoms (120 vs. 220 h, P < 0.0001), less time to a negative PCR test result (215 vs. 310 h, P = 0.0017), shorter hospitalization (14.8 vs. 18.5 days, P = 0.0002), and lower timeframe for defervescence (24.5 vs. 75 h, P = 0.0001) than the control group. In addition, time to improved imaging was also shorter in the RDN group than in the control group (6 vs.8.9 days, P = 0.0273); symptom resolution rates were higher in the RDN group than in the control group at 7 (96.30% vs. 39.13%, P < 0.0001) and 10 days (96.30% vs. 56.52%, P = 0.0008). No allergic reactions or anaphylactic responses were reported in this trial. RDN markedly inhibited SARS-CoV-2 proliferation and viral plaque formation in vitro. In addition, RDN significantly reduced inflammatory cytokine production in infected cells.
RDN relieves clinical symptoms in patients with COVID-19 and reduces SARS-CoV-2 infection by regulating inflammatory cytokine-related disorders, suggestion that this medication might be a safe and effective treatment for COVID-19.
虽然 2019 年冠状病毒病（COVID-19）的迅速出现对全球公共卫生构成了相当大的威胁，但目前尚无针对 COVID-19 的特定治疗方法。热毒宁注射液（RDN）是一种中药，具有抗菌、抗病毒、解热和抗炎作用。此外，国家卫生健康委员会和国家中医药管理局已将 RDN 推荐用于严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）相关肺炎的诊断和治疗。然而，目前尚无关于其对 COVID-19 疗效的信息。
本研究旨在确定 RDN 在 COVID-19 患者中的临床疗效，并研究其在体外对 SARS-CoV-2 的抗病毒活性。
本研究共纳入 50 例 COVID-19 成年患者，主要终点为治疗 14 天后临床症状的恢复情况。一般改善定义为感染的主要症状（发热、疲劳和咳嗽）消失。次要终点包括第 7 天和第 10 天临床症状改善的患者比例、临床症状缓解的时间、临床恢复的时间、核酸检测结果转为阴性的时间、住院时间和退热时间。还进行了体外蚀斑减少和细胞病变效应测定，以及逆转录定量 PCR 以评估 SARS-CoV-2 感染期间炎症细胞因子（TNF-α、IP-10、MCP-1、IL-6、IFN-α、IFN-γ、IL-2 和 CCL-5）的表达。
RDN 组的临床症状缓解中位时间更短（120 小时与 220 小时，P<0.0001），核酸检测结果转为阴性的时间更短（215 小时与 310 小时，P=0.0017），住院时间更短（14.8 天与 18.5 天，P=0.0002），退热时间更短（24.5 小时与 75 小时，P=0.0001），比对照组短。此外，RDN 组的影像学改善时间也短于对照组（6 天与 8.9 天，P=0.0273）；RDN 组在第 7 天（96.30%与 39.13%，P<0.0001）和第 10 天（96.30%与 56.52%，P=0.0008）的症状缓解率高于对照组。本试验中未报告过敏反应或过敏反应。RDN 可显著抑制 SARS-CoV-2 在体外的增殖和病毒蚀斑形成。此外，RDN 可显著减少感染细胞中炎症细胞因子的产生。
RDN 可缓解 COVID-19 患者的临床症状，通过调节炎症细胞因子相关紊乱降低 SARS-CoV-2 感染，提示该药可能是 COVID-19 的一种安全有效的治疗方法。
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