穿心莲内酯和法维吡韦与法维吡韦单药治疗轻度COVID-19感染患者的疗效和安全性对比:多中心随机对照试验

Thaninee Prasoppokakorn, Supachaya Sriphoosanaphan, Nutbordee Nalinthassanai, Thitaporn Roongrawee, P. Hanboonkunupakarn, P. Tangkijvanich, R. Rerknimitr
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摘要

报告显示,穿心莲内酯可抑制病毒复制并减轻 COVID-19 症状。本研究旨在确定穿心莲内酯对接受法非拉韦治疗的轻度COVID-19患者的额外疗效和安全性。2021 年 10 月至 2022 年 2 月期间进行了一项多中心、开放标签、随机对照试验。患者被随机分配接受穿心莲内酯和法非拉韦联合治疗或法非拉韦单药治疗。主要结果是重症肺炎的发生率。次要结果是症状改善、炎症生物标志物以及第7天和第14天的不良反应。82例轻度COVID-19患者接受了治疗,其中43例和39例分别接受了联合疗法或法非拉韦单药治疗。基线特征具有可比性。没有人出现严重肺炎,需要使用机械呼吸机。与对照组相比,穿心莲内酯组咳嗽明显减少;第7天为13(30.2%)对22(56.4%),P = 0.017;第14天为4(9.3%)对7(17.9%),P = 0.025。此外,穿心莲内酯组在第7天的炎症标志物水平明显降低,CRP(5.8 vs. 18.4 mg/L;p = 0.019)和IL-6(2.0 vs. 21.8 pg/mL;p = 0.001),但在第14天没有明显降低。关于安全性结果,穿心莲内酯组在第7天的AST水平(40.3 vs. 32.2 U/L;p = 0.030)以及第14天的AST和ALT水平(分别为55.3 vs. 32.0;p = 0.014和63.8 vs. 40.0;p = 0.022)均显著升高。在病情较轻的 COVID-19 患者中,在预防重症肺炎方面,穿心莲内酯和法非拉韦的联合治疗并未显示出比单独使用法非拉韦更多的益处。不过,穿心莲内酯能明显减轻咳嗽症状,尤其是在第一周。此外,尽管存在轻度转氨酶炎,但接受穿心莲内酯治疗的患者的炎症指标有所改善。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy and Safety of Andrographolide and Favipiravir Versus Favipiravir Monotherapy in Patients with Mild COVID-19 Infection: A Multicenter Randomized Controlled Trial
Reports indicate that Andrographolide inhibits viral replication and reduces COVID-19 symptoms. This study aimed to determine Andrographolide's additional effect and safety in mild COVID-19 patients treated with favipiravir. A multicenter, open-labeled, randomized controlled trial was conducted from October 2021 to February 2022. The patients were randomized to receive a combination of Andrographolide and favipiravir or favipiravir monotherapy. The primary outcome was the occurrence rate of severe pneumonia. The secondary outcomes were symptom improvement, inflammatory biomarkers, and adverse events on days 7 and 14. 82 mild COVID-19 patients were enrolled; 43 and 39 patients received either combination therapy or favipiravir alone. Baseline characteristics were comparable. None developed severe pneumonia, requiring a mechanical ventilator. The Andrographolide group had a significant reduction of cough compared to the controlled group; 13 (30.2%) vs. 22 (56.4%), p = 0.017 on day 7 and 4 (9.3%) vs. 7 (17.9%), p = 0.025 on day 14. Moreover, the Andrographolide group had significantly lower levels of inflammatory markers on day 7, CRP (5.8 vs. 18.4 mg/L; p = 0.019) and IL-6 (2.0 vs. 21.8 pg/mL; p = 0.001) but not on day 14. Regarding safety outcomes, the Andrographolide group had significantly higher AST levels on day 7 (40.3 vs. 32.2 U/L; p = 0.030) and both AST and ALT levels on day 14 (55.3 vs. 32.0; p = 0.014 and 63.8 vs. 40.0; p = 0.022, respectively). In mild COVID-19 patients, the combination of Andrographolide and favipiravir did not demonstrate additional benefits over favipiravir alone in preventing severe pneumonia. However, Andrographolide significantly reduced cough symptoms, especially during the first week. Furthermore, despite mild transaminitis, patients treated with Andrographolide showed improvements in inflammatory markers.
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