英国伦敦大学学院医院Geoff Bellingan小组研究了静脉注射干扰素β-1a对中重度急性呼吸窘迫综合征患者死亡和无机械通气天数的影响。相关论文于2020年2月17日发表在《美国医学会杂志》上。

急性呼吸窘迫综合征（ARDS）与高死亡率有关。干扰素（IFN）β-1a可预防血管渗漏的发生。

为了探讨IFN-β-1a治疗中重度ARDS的疗效及不良反应，2015年12月至2017年12月，研究组在欧洲8个国家的74个重症监护室进行了一项多中心、随机、双盲、平行组试验，根据柏林定义，招募了296名中重度ARDS成人患者，平均年龄58岁。将其随机分组，其中144例接受静脉注射IFN-β-1a，152例接受安慰剂治疗，每日1次，连续6天。

28天时，IFN-β-1a组的死亡和无呼吸机天数的综合得分中位数为10天，安慰剂组为8.5天。IFN-β-1a组28天死亡率为26.4%，安慰剂组为23.0%，无显著差异。IFN-β-1a组中有28.5%的患者经历了与治疗有关的不良事件，安慰剂组中有21.7%。

总之，成人中重度ARDS患者静脉注射IFN-β-1a持续6天，与安慰剂组相比，其28天死亡和无呼吸机天数的综合评分并无显著差异。该结果不支持IFN-β-1a用于治疗ARDS。

附：英文原文

Title: Effect of Intravenous Interferon β-1a on Death and Days Free From Mechanical Ventilation Among Patients With Moderate to Severe Acute Respiratory Distress Syndrome: A Randomized Clinical Trial

Author: V. Marco Ranieri, Ville Pettil, Matti K. Karvonen, Juho Jalkanen, Peter Nightingale, David Brealey, Jordi Mancebo, Ricard Ferrer, Alain Mercat, Nicolò Patroniti, Michael Quintel, Jean-Louis Vincent, Marjatta Okkonen, Ferhat Meziani, Giacomo Bellani, Niall MacCallum, Jacques Creteur, Stefan Kluge, Antonio Artigas-Raventos, Mikael Maksimow, Ilse Piippo, Kati Elima, Sirpa Jalkanen, Markku Jalkanen, Geoff Bellingan

Issue&Volume: February 17, 2020

Abstract: Importance  Acute respiratory distress syndrome (ARDS) is associated with high mortality. Interferon (IFN) β-1a may prevent the underlying event of vascular leakage.Objective  To determine the efficacy and adverse events of IFN-β-1a in patients with moderate to severe ARDS.Design, Setting, and Participants  Multicenter, randomized, double-blind, parallel-group trial conducted at 74 intensive care units in 8 European countries (December 2015-December 2017) that included 301 adults with moderate to severe ARDS according to the Berlin definition. The radiological and partial pressure of oxygen, arterial (Pao2)/fraction of inspired oxygen (Fio2) criteria for ARDS had to be met within a 24-hour period, and the administration of the first dose of the study drug had to occur within 48 hours of the diagnosis of ARDS. The last patient visit was on March 6, 2018.Interventions  Patients were randomized to receive an intravenous injection of 10 μg of IFN-β-1a (144 patients) or placebo (152 patients) once daily for 6 days.Main Outcomes and Measures  The primary outcome was a score combining death and number of ventilator-free days at day 28 (score ranged from 1 for death to 27 if the patient was off ventilator on the first day). There were 16 secondary outcomes, including 28-day mortality, which were tested hierarchically to control type I error.Results  Among 301 patients who were randomized (mean age, 58 years; 103 women [34.2%]), 296 (98.3%) completed the trial and were included in the primary analysis. At 28 days, the median composite score of death and number of ventilator-free days at day 28 was 10 days (interquartile range, 1 to 20) in the IFN-β-1a group and 8.5 days (interquartile range, 0 to 20) in the placebo group (P=.82). There was no significant difference in 28-day mortality between the IFN-β-1a vs placebo groups (26.4% vs 23.0%; difference, 3.4% [95% CI, 8.1% to 14.8%]; P=.53). Seventy-four patients (25.0%) experienced adverse events considered to be related to treatment during the study (41 patients [28.5%] in the IFN-β-1a group and 33 [21.7%] in the placebo group).Conclusions and Relevance  Among adults with moderate or severe ARDS, intravenous IFN-β-1a administered for 6 days, compared with placebo, resulted in no significant difference in a composite score that included death and number of ventilator-free days over 28 days. These results do not support the use of IFN-β-1a in the management of ARDS.

DOI: 10.1001/jama.2019.22525

Source: https://jamanetwork.com/journals/jama/fullarticle/2761314