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金纽扣辅助治疗 COVID-19 轻症病毒性呼吸道感染的随机、安慰剂对照、开放标签临床试验:初步结果。

Achyrocline satureioides as an adjuvant therapy for the management of mild viral respiratory infections in the context of COVID-19: Preliminary results of a randomized, placebo-controlled, and open-label clinical trial.

机构信息

Programa de Pós-Graduação em Ciências Biológicas: Farmacologia e Terapêutica, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.

Programa de Pós-Graduação em Ciências Biológicas: Fisiologia, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.

出版信息

Phytother Res. 2023 Nov;37(11):5354-5365. doi: 10.1002/ptr.7976. Epub 2023 Aug 15.

Abstract

We evaluated the impact of an Achyrocline satureioides inflorescence infusion on the clinical outcomes of viral respiratory infections, including those caused by SARS-CoV-2, in a monocentric, randomized, open-label, placebo-controlled clinical trial. Patients with symptoms of viral respiratory infection, including suspected cases of COVID-19, were included and assigned to receive either A. satureioides (n = 57) or Malus domestica (n = 67) infusions twice a day for 14 days. All participants were included before the RT-PCR results, performed using a nasopharyngeal swab. The patients were further divided into subgroups according to real-time polymerase chain reaction results: SARS-CoV-2-positive and SARS-CoV-2-negative subgroups for statistical analyses. We assessed clinical outcomes, such as the latency to resolution of cough, dyspnea, fever, sore throat, chest pain, smell and taste dysfunctions, diarrhea, nausea, abdominal pain, and loss of appetite; hospitalization; and mortality with questionnaires and medical records. The subjects that received early A. satureioides infusion showed a significant reduction in the average number of days with respiratory and neurological symptoms compared with the control group (M. domestica infusion). We conclude that A. satureioides is a safe agent and, in combination with standard care, improves viral respiratory infection symptoms, especially those related to COVID-19.

摘要

我们在一项单中心、随机、开放标签、安慰剂对照临床试验中评估了糙叶南美蟛蜞菊花序浸剂对包括 SARS-CoV-2 在内的病毒呼吸道感染的临床结局的影响。入组了有病毒呼吸道感染症状的患者,包括疑似 COVID-19 的病例,并将其分为糙叶南美蟛蜞菊组(n=57)和苹果组(n=67),两组均接受每日两次、为期 14 天的治疗。所有患者在进行鼻咽拭子实时聚合酶链反应(RT-PCR)检测之前均入组。根据 RT-PCR 结果,将患者进一步分为亚组进行统计学分析:SARS-CoV-2 阳性和 SARS-CoV-2 阴性亚组。我们使用问卷和病历评估了临床结局,如咳嗽、呼吸困难、发热、咽痛、胸痛、嗅觉和味觉障碍、腹泻、恶心、腹痛和食欲不振的缓解潜伏期、住院和死亡率。与对照组(苹果组)相比,早期接受糙叶南美蟛蜞菊组治疗的患者呼吸道和神经系统症状的平均持续天数显著减少。我们的结论是,糙叶南美蟛蜞菊是一种安全的药物,与标准治疗相结合可以改善病毒呼吸道感染症状,特别是与 COVID-19 相关的症状。

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