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氟伏沙明可显著降低门诊症状性COVID-19患者的临床恶化风险
作者:小柯机器人 发布时间:2020/11/16 14:10:21

美国华盛顿大学医学院Eric J. Lenze团队比较了氟伏沙明与安慰剂治疗门诊症状性COVID-19患者的临床恶化风险。2020年11月12日,该研究发表在《美国医学会杂志》上。

COVID-19的过度免疫反应可能会导致严重疾病。氟伏沙明可通过刺激调节细胞因子产生的σ-1受体来预防临床恶化。

为了确定在轻度COVID-19疾病期间给予氟伏沙明是否可防止临床恶化并减轻疾病的严重程度,2020年4月10日至8月5日,研究组进行了一项氟伏沙明与安慰剂的双盲、随机、完全远程(非接触式)的临床试验。在圣路易斯大都市区招募了152例非住院、居住在社区、已证实新冠病毒感染、7天内出现COVID-19症状、血氧饱和度为92%及以上的成人患者。

将参与者随机分组,其中80例接受氟伏沙明治疗,72例接受安慰剂治疗,每日3次,持续15天。主要结局为随机分组后15天内出现临床恶化,定义为满足以下两个标准:(1)呼吸急促或因呼吸急促或肺炎而住院;(2)室内空气血氧饱和度低于92%或需要补充氧气才能达到92%及以上的氧饱和度。

152名患者的平均年龄为46岁,72%为女性,共有115名(76%)患者完成了试验。氟伏沙明组中没有一例患者发生临床恶化,安慰剂组中有6例,组间差异显著。氟伏沙明组发生1个严重不良事件和11个其他不良事件,而安慰剂组则发生6个严重不良事件和12个其他不良事件。

总之,对于有症状的COVID-19成人门诊患者,与安慰剂相比,氟伏沙明治疗可显著降低15天内临床恶化的风险。

附:英文原文

Title: Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19: A Randomized Clinical Trial

Author: Eric J. Lenze, Caline Mattar, Charles F. Zorumski, Angela Stevens, Julie Schweiger, Ginger E. Nicol, J. Philip Miller, Lei Yang, Michael Yingling, Michael S. Avidan, Angela M. Reiersen

Issue&Volume: 2020-11-12

Abstract:

Importance  Coronavirus disease 2019 (COVID-19) may lead to serious illness as a result of an excessive immune response. Fluvoxamine may prevent clinical deterioration by stimulating the σ-1 receptor, which regulates cytokine production.

Objective  To determine whether fluvoxamine, given during mild COVID-19 illness, prevents clinical deterioration and decreases the severity of disease.

Design, Setting, and Participants  Double-blind, randomized, fully remote (contactless) clinical trial of fluvoxamine vs placebo. Participants were community-living, nonhospitalized adults with confirmed severe acute respiratory syndrome coronavirus 2 infection, with COVID-19 symptom onset within 7 days and oxygen saturation of 92% or greater. One hundred fifty-two participants were enrolled from the St Louis metropolitan area (Missouri and Illinois) from April 10, 2020, to August 5, 2020. The final date of follow-up was September 19, 2020.

Interventions  Participants were randomly assigned to receive 100 mg of fluvoxamine (n=80) or placebo (n=72) 3 times daily for 15 days.

Main Outcomes and Measures  The primary outcome was clinical deterioration within 15 days of randomization defined by meeting both criteria of (1) shortness of breath or hospitalization for shortness of breath or pneumonia and (2) oxygen saturation less than 92% on room air or need for supplemental oxygen to achieve oxygen saturation of 92% or greater.

Results  Of 152 patients who were randomized (mean [SD] age, 46 [13] years; 109 [72%] women), 115 (76%) completed the trial. Clinical deterioration occurred in 0 of 80 patients in the fluvoxamine group and in 6 of 72 patients in the placebo group (absolute difference, 8.7% [95% CI, 1.8%-16.4%] from survival analysis; log-rank P=.009). The fluvoxamine group had 1 serious adverse event and 11 other adverse events, whereas the placebo group had 6 serious adverse events and 12 other adverse events.

Conclusions and Relevance  In this preliminary study of adult outpatients with symptomatic COVID-19, patients treated with fluvoxamine, compared with placebo, had a lower likelihood of clinical deterioration over 15 days. However, the study is limited by a small sample size and short follow-up duration, and determination of clinical efficacy would require larger randomized trials with more definitive outcome measures.

DOI: 10.1001/jama.2020.22760

Source: https://jamanetwork.com/journals/jama/fullarticle/2773108

期刊信息

JAMA-Journal of The American Medical Association:《美国医学会杂志》,创刊于1883年。隶属于美国医学协会,最新IF:51.273
官方网址:https://jamanetwork.com/
投稿链接:http://manuscripts.jama.com/cgi-bin/main.plex