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高剂量维生素 D 对中重度 COVID-19 患者过度炎症状态疗效的证据:一项随机临床试验。

Evidence for the Efficacy of a High Dose of Vitamin D on the Hyperinflammation State in Moderate-to-Severe COVID-19 Patients: A Randomized Clinical Trial.

机构信息

Clinical Pharmacy Department, Faculty of Pharmacy, Misr International University, Cairo 11828, Egypt.

Clinical Pharmacy Department, Faculty of Pharmacy, October 6 University, P.O. Box 12585, Giza 12585, Egypt.

出版信息

Medicina (Kaunas). 2022 Sep 27;58(10):1358. doi: 10.3390/medicina58101358.

Abstract

Vitamin D supplementation plays a key effect in lowering cytokine storms among COVID-19 patients by influencing the activity of the renin-angiotensin system and the production of the angiotensin-2 converting enzyme. The study was conducted to explore the effect of high-dose intramuscular vitamin D in hospitalized adults infected with moderate-to-severe SARS-CoV-2 in comparison with the standard of care in the COVID-19 protocol. Two groups of patients were compared in this prospective randomized controlled trial as the vitamin D was administered orally to group 1 (alfacalcidol 1 mcg/day) and intramuscularly to group 2 (cholecalciferol 200,000 IU). One hundred and sixteen participants were recruited in total, with fifty-eight patients in each group. Following the Egyptian Ministry of Health's policy for COVID-19 management, all patients received the same treatment for a minimum of five days. A significant difference was recorded in the length of hospital stay (8.6 versus 6.8 days), need for high oxygen or non-invasive mechanical ventilator (67% versus 33%), need for a mechanical ventilator (25% versus 75%), clinical improvement (45% versus 55%), the occurrence of sepsis (35% versus 65%), and in the monitored laboratory parameters in favor of high-dose vitamin D. Moreover, clinical improvement was significantly associated with the need for low/high oxygen, an invasive/non-invasive mechanical ventilator (MV/NIMV), and diabetes, while mortality was associated with the need for MV, ICU admission, atrial fibrillation, chronic obstructive pulmonary disease, asthma, and the occurrence of secondary infection. Our study showed that high-dose vitamin D was considered a promising treatment in the suppression of cytokine storms among COVID-19 patients and was associated with better clinical improvement and fewer adverse outcomes compared to low-dose vitamin D.

摘要

维生素 D 补充剂通过影响肾素-血管紧张素系统的活性和血管紧张素转换酶的产生,在降低 COVID-19 患者的细胞因子风暴方面发挥关键作用。本研究旨在探讨与 COVID-19 方案中的标准治疗相比,大剂量肌肉内维生素 D 对住院的中度至重度 SARS-CoV-2 感染成人的影响。在这项前瞻性随机对照试验中,将患者分为两组,一组口服阿尔法骨化醇(1 微克/天),另一组肌肉内注射胆钙化醇(20 万国际单位)。总共招募了 116 名参与者,每组 58 名。根据埃及卫生部 COVID-19 管理政策,所有患者接受至少 5 天的相同治疗。住院时间(8.6 天与 6.8 天)、需要高氧或无创机械通气(67%与 33%)、需要机械通气(25%与 75%)、临床改善(45%与 55%)、脓毒症(35%与 65%)以及支持大剂量维生素 D 的监测实验室参数方面存在显著差异。此外,临床改善与需要低/高氧、有创/无创机械通气(MV/NIMV)和糖尿病显著相关,而死亡率与需要 MV、入住 ICU、心房颤动、慢性阻塞性肺疾病、哮喘和继发感染相关。我们的研究表明,与低剂量维生素 D 相比,大剂量维生素 D 被认为是 COVID-19 患者细胞因子风暴抑制的一种有前途的治疗方法,与更好的临床改善和更少的不良结局相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0161/9609310/e024714642e2/medicina-58-01358-g001.jpg

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