Efficacy and safety of ReDuNing injection as a treatment for COVID-19 and its inhibitory effect against SARS-CoV-2.

Efficacy and safety of ReDuNing injection as a treatment for COVID-19 and its inhibitory effect against SARS-CoV-2.
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DOI:
10.1016/j.jep.2021.114367
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发表时间:
2021-10-28
影响因子:
5.4
通讯作者:
Yang Z
Yang Z
中科院分区:
医学2区
文献类型:
--
作者:
Ma Q;Xie Y;Wang Z;Lei B;Chen R;Liu B;Jiang H;Wang Y;Liu Q;Yang Z

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尽管2019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。热毒宁注射液是一种具有抗菌、抗病毒、解热、抗炎作用的中药。此外,国家卫生理事会和国家中医药管理局已推荐RDN用于严重急性呼吸综合征冠状病毒2型(SARS-CoV-2)相关肺炎的诊断和治疗。然而,并无有关其对COVID-19的疗效的资料。本研究旨在确定RDN在COVID-19患者中的临床疗效,并表征其体外抗SARS-CoV-2的抗病毒活性。本研究共纳入了50名患有COVID-19的成年人,主要终点是治疗14天后从临床症状中恢复。一般改善定义为主要感染症状(包括发热、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、临床恢复时间、核酸检测结果阴性时间、住院时间和退热时间。采用体外空斑减少实验和细胞病变实验,逆转录定量PCR检测SARS-CoV-2感染后TNF-α、IP-10、MCP-1、IL-6、IFN-α、IFN-γ、IL-2和CCL-5的表达。RDN组临床症状缓解的中位时间较短(120 vs. 220 h,P < 0.0001),PCR检测结果阴性的时间更短(215 vs. 310 h,P = 0.0017),住院时间更短(14.8 vs. 18.5天,P = 0.0002),退热时间段(24.5 vs. 75 h,P = 0.0001)低于对照组。此外,RDN组的影像学改善时间也短于对照组(6天vs.8.9天,P = 0.0273); RDN组的症状缓解率高于对照组,术后10天(96.30% vs. 56.52%,P = 0.0008)。本试验中未报告过敏反应或速发过敏反应。RDN对SARS-CoV-2的增殖和病毒空斑的形成有明显的抑制作用。此外,RDN显着减少感染细胞中炎性细胞因子的产生。RDN可缓解COVID-19患者的临床症状,并通过调节炎性神经递质相关疾病来减少SARS-CoV-2感染,这表明这种药物可能是COVID-19的安全有效的治疗方法。
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.
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发表时间: 2020-03-26
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