Low-dose whole-lung radiation for COVID-19 pneumonia: Planned day 7 interim analysis of a registered clinical trial.
Low-dose whole-lung radiation for COVID-19 pneumonia: Planned day 7 interim analysis of a registered clinical trial.
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Covid-19-19肺炎的低剂量全肺辐射：计划的第7天进行了注册临床试验的临时分析。
作者：
Hess CB;Buchwald ZS;Stokes W;Nasti TH;Switchenko JM;Weinberg BD;Steinberg JP;Godette KD;Murphy D;Ahmed R;Curran WJ Jr;Khan MK
患有合并症的高龄个体面临更高的2019冠状病毒病（COVID-19）死亡风险，特别是一旦他们依赖呼吸机。COVID-19患者的呼吸下降是由肺介导的异常免疫细胞因子风暴引起的。在抗生素出现之前，低剂量肺放射被用于治疗肺炎。放射免疫调节作用可能会改善部分COVID-19患者的预后。一项评估单次低剂量全肺放疗对COVID-19肺炎患者的安全性和有效性的单机构试验正在首次进行。本报告描述了计划的第7天中期分析的结局。符合条件的患者住院，影像学巩固，需要补充氧气，临床恶化。在筛选的9名患者中，5名在2020年4月24日至4月28日接受了全肺放射治疗，并随访了至少7天。中位年龄为90岁（范围：64-94岁），4例为疗养院居民，伴有多种合并症。在放射治疗的24小时内，3名患者（60%）从辅助供氧转为环境空气，4名患者（80%）显示影像学改善，中位格拉斯哥昏迷量表评分从10分改善至14分。第4例患者（总体恢复率80%）在96小时时断氧。至临床恢复的平均时间为35小时。无急性毒性。在一项针对5名患有COVID-19肺炎的氧依赖型老年患者的先导性试验中，低剂量全肺放疗导致临床状态、脑病和影像学实变迅速改善，且无急性毒性。低剂量全肺放疗似乎是安全的，显示出早期疗效的承诺，并值得进一步研究。·埃默里大学的研究人员报告了接受低剂量肺照射治疗2019冠状病毒病（COVID-19）肺炎患者的初步安全性结果。·五名疗养院或团体之家的居民在COVID-19检测呈阳性后住院。每个人都有肺炎可见的胸部X光片，需要补充氧气，并经历了临床下降的精神状态或工作的呼吸或延长或升级的补充氧气的需求。·在10至15分钟的过程中对两个肺进行低剂量（1.5-戈伊）辐射的单次治疗。没有急性毒性归因于放射治疗。在24小时内，4例患者呼吸迅速改善，平均1.5天（范围，3-96小时）恢复到室内空气。3例平均出院12天，1例准备出院。·血液检查和重复成像证实，低剂量全肺放射治疗对COVID-19肺炎似乎是安全的。还需要进行进一步的审判。
Individuals of advanced age with comorbidities face a higher risk of death from coronavirus disease 2019 (COVID-19), especially once they are ventilator-dependent. Respiratory decline in patients with COVID-19 is precipitated by a lung-mediated aberrant immune cytokine storm. Low-dose lung radiation was used to treat pneumonia in the pre-antibiotic era. Radiation immunomodulatory effects may improve outcomes for select patients with COVID-19. A single-institution trial evaluating the safety and efficacy of single-fraction, low-dose whole-lung radiation for patients with COVID-19 pneumonia is being performed for the first time. This report describes outcomes of a planned day 7 interim analysis. Eligible patients were hospitalized, had radiographic consolidation, required supplemental oxygen, and were clinically deteriorating. Of 9 patients screened, 5 were treated with whole-lung radiation on April 24 until April 28 2020, and they were followed for a minimum of 7 days. The median age was 90 years (range, 64-94 years), and 4 were nursing home residents with multiple comorbidities. Within 24 hours of radiation, 3 patients (60%) were weaned from supplemental oxygen to ambient air, 4 (80%) exhibited radiographic improvement, and the median Glasgow Coma Scale score improved from 10 to 14. A fourth patient (80% overall recovery) was weaned from oxygen at hour 96. The mean time to clinical recovery was 35 hours. There were no acute toxicities. In a pilot trial of 5 oxygen-dependent elderly patients with COVID-19 pneumonia, low-dose whole-lung radiation led to rapid improvements in clinical status, encephalopathy, and radiographic consolidation without acute toxicity. Low-dose whole-lung radiation appears to be safe, shows early promise of efficacy, and warrants further study. • Researchers at Emory University report preliminary safety outcomes for patients treated with low-dose lung irradiation for coronavirus disease 2019 (COVID-19) pneumonia. • Five residents of nursing or group homes were hospitalized after testing positive for COVID-19. Each had pneumonia visible on a chest x-ray, required supplemental oxygen, and experienced a clinical decline in mental status or in work of breathing or a prolonged or escalating supplemental oxygen requirement. • A single treatment of low-dose (1.5-Gy) radiation to both lungs was delivered over the course of 10 to 15 minutes. There was no acute toxicity attributable to radiation therapy. Within 24 hours, 4 patients had rapidly improved breathing, and they recovered to room air at an average of 1.5 days (range, 3-96 hours). Three were discharged at a mean time of 12 days, and 1 was preparing for discharge. • Blood tests and repeat imaging confirm that low-dose whole-lung radiation treatment appears safe for COVID-19 pneumonia. Further trials are warranted.
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