在中度至重度COVID-19的住院患者中服用中间剂量的埃诺沙巴林:试点II期单臂研究,INHIXACOVID19
B Cosmi1,2, M Giannella3, G Fornaro4
1Angiology and Blood Coagulation Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Via Albertoni, 15, Bologna, Italy. benilde.cosmi@unibo.it.
BMC infectious diseases
|October 24, 2023
概括
与标准预防药物相比,中剂量氧巴林在住院COVID-19患者中显示出类似的安全性和潜在益处. 这种体重调整的肝素治疗方案与抗FXa监测似乎是安全的,并可能改善临床结果.
科学领域:
- 心脏病学 心脏病学
- 传染性疾病 传染性疾病
- 药理学 药理学是指药理学的学科.
背景情况:
- 治疗剂量氨酸在非危急病的COVID-19患者中改善了生存率,但增加了出血风险.
- 之前的试验表明,在COVID-19中使用肝素有好处,因此需要进一步评估安全性和有效性.
研究的目的:
- 评估中剂量埃诺沙巴林在中度至重度COVID-19住院患者的安全性和临床影响.
- 为了比较体重调整的中间剂量氧巴林与标准氧巴林预防的结果.
主要方法:
- 一个前性的,单臂的,二期研究中期剂量素 (60-100毫克每天) 与抗Xa因子监测.
- 与接受标准埃诺沙巴林 (每天40毫克) 的观察队列进行比较;90天的随访.
- 主要结局:严重出血;次要结局:死亡率,疾病严重程度,重症监护室入院和住院时间;倾向性得分匹配用于分析.
主要成果:
- 大型出血率较低,在中剂量埃诺沙巴林组 (1.02%) 和观察队列 (0%) 之间相似.
- 死亡率和疾病严重程度的综合结果显示,中间剂量组的后倾向性得分匹配趋势有所改善 (55.6%对62.2%).
- 在倾向性得分匹配之前,中间剂量组的住院时间明显较短 (p=0.001).
结论:
- 体重调整的中间剂量素与抗FXa监测对于住院的COVID-19患者是安全的.
- 这种方案显示了对COVID-19的临床过程产生积极影响的潜力.
- 进一步的研究可能会证实这种抗凝血策略的好处.
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