Reumatologia, Dipartimento di Medicina e Chirurgia, Università degli Studi di Perugia, Perugia, Italy.
Ospedale di Esine, ASST Valcamonica, Esine (BS).
Eur J Intern Med. 2023 Jan;107:30-36. doi: 10.1016/j.ejim.2022.10.016. Epub 2022 Oct 31.
To evaluate whether the addition of colchicine to standard of care (SOC) results in better outcomes in hospitalized patients with COVID-19.
This interventional, multicenter, randomized, phase 2 study, evaluated colchicine 1.5 mg/day added to SOC in hospitalized COVID-19 patients (COLVID-19 trial) and 227 patients were recruited. The primary outcome was the rate of critical disease in 30 days defined as need of mechanical ventilation, intensive care unit (ICU), or death.
152 non-anti-SARS-CoV-2-vaccinated patients (colchicine vs controls: 77vs75, mean age 69.1±13.1 vs 67.9±15 years, 39% vs 33.3% females, respectively) were analyzed. There was no difference in co-primary end-points between patients treated with colchicine compared to controls (mechanical ventilation 5.2% vs 4%, ICU 1.3% vs 5.3%, death 9.1% vs 6.7%, overall 11 (14.3%) vs 10 (13.3%) patients, P=ns, respectively). Mean time to discharge was similar (colchicine vs controls 14.1±10.4 vs 14.7±8.1 days). Older age (>60 years, P=0.025), P/F<275 mmHg (P=0.005), AST>40 U/L (P<0.001), pre-existent heart (P=0.02), lung (P=0.003), upper-gastrointestinal (P=0.014), lower-gastrointestinal diseases (P=0.009) and cancer (P=0.008) were predictive of achieving the primary outcome. Diarrhoea (9.1% vs 0%, p=0.0031) and increased levels of AST at 6 days (76.9±91.8 vs 33.5±20.7 U/l, P=0.016) were more frequent in the colchicine group.
Colchicine did not reduce the rate and the time to the critical stage. Colchicine was relatively safe although adverse hepatic effects require caution. We confirm that older (>60 years) patients with comorbidities are characterized by worse outcome.
评估在 COVID-19 住院患者中，秋水仙碱联合标准治疗（SOC）是否比 SOC 单独治疗有更好的结果。
这项干预性、多中心、随机、2 期研究评估了 COVID-19 住院患者中每天服用 1.5 毫克秋水仙碱联合 SOC（COLVID-19 试验）的效果，共招募了 227 名患者。主要结局是 30 天内发生危急疾病的发生率，定义为需要机械通气、重症监护病房（ICU）或死亡。
分析了 152 名未接种抗 SARS-CoV-2 疫苗的患者（秋水仙碱组 vs 对照组：77 例 vs 75 例，平均年龄 69.1±13.1 岁 vs 67.9±15 岁，分别为 39% vs 33.3%女性）。与对照组相比，接受秋水仙碱治疗的患者在联合主要终点方面没有差异（机械通气 5.2% vs 4%，ICU 1.3% vs 5.3%，死亡 9.1% vs 6.7%，总体 11（14.3%） vs 10（13.3%）患者，P=无统计学意义）。出院时间相似（秋水仙碱组 vs 对照组 14.1±10.4 天 vs 14.7±8.1 天）。年龄较大（>60 岁，P=0.025）、P/F<275mmHg（P=0.005）、AST>40U/L（P<0.001）、预先存在的心脏疾病（P=0.02）、肺部疾病（P=0.003）、上消化道疾病（P=0.014）、下消化道疾病（P=0.009）和癌症（P=0.008）是达到主要结局的预测因素。秋水仙碱组更常见腹泻（9.1% vs 0%，p=0.0031）和第 6 天 AST 水平升高（76.9±91.8 vs 33.5±20.7 U/l，P=0.016）。
秋水仙碱并没有降低危急阶段的发生率和时间。秋水仙碱相对安全，尽管肝不良反应需要谨慎。我们确认年龄较大（>60 岁）的合并症患者的结局更差。
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