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喜炎平注射液治疗 COVID-19 的疗效和安全性:一项多中心、前瞻性、开放标签、随机对照试验。

Efficacy and safety of Xiyanping injection in the treatment of COVID-19: A multicenter, prospective, open-label and randomized controlled trial.

机构信息

Department of Respiratory Diseases, The Second Affiliated Hospital of Nanchang University, Nanchang, China.

Department of Drug Research, State Key Laboratory of Innovative Natural Medicine and TCM Injections, Ganzhou, China.

出版信息

Phytother Res. 2021 Aug;35(8):4401-4410. doi: 10.1002/ptr.7141. Epub 2021 May 12.

Abstract

Xiyanping (XYP) is a Chinese herbal medicine used in the clinic to treat respiratory infection and pneumonia. Recent evidence identified XYP as a potential inhibitor of severe acute respiratory syndrome coronavirus 2, implying XYP as a possible treatment for the coronavirus disease 2019 (COVID-19). Here, we conducted a prospective, multicenter, open-label and randomized controlled trial to evaluate the safety and effectiveness of XYP injection in patients with mild to moderate COVID-19. We consecutively recruited 130 COVID-19 patients with mild to moderate symptoms from five study sites, and randomized them in 1:1 ratio to receive XYP injection in combination with standard therapy or receive standard supportive therapy alone. We found that XYP injection significantly reduced the time to cough relief, fever resolution and virus clearance. Less patients receiving XYP injection experienced disease progression to the severe stage during the treatment process. No severe adverse events were reported during the study. Taken together, XYP injection is safe and effective in improving the recovery of patients with mild to moderate COVID-19. However, further studies are warranted to evaluate the efficacy of XYP in an expanded cohort comprising COVID-19 patients at different disease stages.

摘要

喜炎平(XYP)是一种中药,临床上用于治疗呼吸道感染和肺炎。最近的证据表明,XYP 可能是严重急性呼吸综合征冠状病毒 2 的潜在抑制剂,这意味着 XYP 可能是治疗 2019 年冠状病毒病(COVID-19)的一种方法。在这里,我们进行了一项前瞻性、多中心、开放标签和随机对照试验,以评估 XYP 注射液在轻度至中度 COVID-19 患者中的安全性和有效性。我们连续从五个研究地点招募了 130 名有轻度至中度症状的 COVID-19 患者,并以 1:1 的比例随机分配他们接受 XYP 注射液联合标准治疗或仅接受标准支持治疗。我们发现 XYP 注射液显著缩短了咳嗽缓解、退热和病毒清除的时间。接受 XYP 注射液治疗的患者在治疗过程中病情进展为重症的比例较低。研究过程中未报告严重不良事件。总之,XYP 注射液在改善轻度至中度 COVID-19 患者的康复方面是安全有效的。然而,需要进一步的研究来评估 XYP 在包括不同疾病阶段的 COVID-19 患者在内的扩展队列中的疗效。

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