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单次大剂量维生素D3治疗并不能缩短中重度COVID-19患者的住院时间
作者:小柯机器人 发布时间:2021/2/19 15:17:06

巴西圣保罗大学Rosa Maria Rodrigues Pereira团队研究了单次服用大剂量维生素D3对中重度COVID-19患者住院时间的影响。2021年2月17日,《美国医学会杂志》发表了该成果。

补充维生素D3对COVID-19的疗效尚不明确。

为了探讨单次大剂量维生素D3对COVID-19患者住院时间的影响,研究组在巴西圣保罗的2个机构进行了一项多中心、双盲、随机、安慰剂对照试验,招募了240名在2020年6月2日至8月27日住院的COVID-19中重度患者。将其随机分组,其中120例接受单剂量口服200?000 IU维生素D3,120例口服安慰剂。主要结局为住院时间,定义为从随机分组到出院的时间。

240名患者中共有237名被纳入初步分析,平均年龄为56.2岁,其中43.9%为女性,25-羟基维生素D的平均基线水平为20.9 ng/mL。维生素D3组和安慰剂组的中位住院时间均为7.0天,差异不显著。维生素D3组和安慰剂组的住院死亡率分别为7.6%和5.1%,重症监护病房入住率分别为16.0%和21.2%,需要机械通气率分别为7.6%和14.4%,差异均不显著。单剂量维生素D3组的25-羟基维生素D的平均血清水平为44.4 ng/mL,显著高于安慰剂组(19.8 ng/mL)。没有不良反应发生,仅有一次与干预有关的呕吐。

研究结果表明,对于COVID-19住院患者,单次高剂量维生素D3治疗与安慰剂相比,并没有显著缩短住院时间。研究结果不支持使用大剂量维生素D3治疗中重度COVID-19。

附:英文原文

Title: Effect of a Single High Dose of Vitamin D3 on Hospital Length of Stay in Patients With Moderate to Severe COVID-19: A Randomized Clinical Trial

Author: Igor H. Murai, Alan L. Fernandes, Lucas P. Sales, Ana J. Pinto, Karla F. Goessler, Camila S. C. Duran, Carla B. R. Silva, André S. Franco, Marina B. Macedo, Henrique H. H. Dalmolin, Janaina Baggio, Guilherme G. M. Balbi, Bruna Z. Reis, Leila Antonangelo, Valeria F. Caparbo, Bruno Gualano, Rosa M. R. Pereira

Issue&Volume: 2021-02-17

Abstract:

Importance  The efficacy of vitamin D3 supplementation in coronavirus disease 2019 (COVID-19) remains unclear.

Objective  To investigate the effect of a single high dose of vitamin D3 on hospital length of stay in patients with COVID-19.

Design, Setting, and Participants  This was a multicenter, double-blind, randomized, placebo-controlled trial conducted in 2 sites in Sao Paulo, Brazil. The study included 240 hospitalized patients with COVID-19 who were moderately to severely ill at the time of enrollment from June 2, 2020, to August 27, 2020. The final follow-up was on October 7, 2020.

Interventions  Patients were randomly assigned to receive a single oral dose of 200000 IU of vitamin D3 (n=120) or placebo (n=120).

Main Outcomes and Measures  The primary outcome was length of stay, defined as the time from the date of randomization to hospital discharge. Prespecified secondary outcomes included mortality during hospitalization; the number of patients admitted to the intensive care unit; the number of patients who required mechanical ventilation and the duration of mechanical ventilation; and serum levels of 25-hydroxyvitamin D, total calcium, creatinine, and C-reactive protein.

Results  Of 240 randomized patients, 237 were included in the primary analysis (mean [SD] age, 56.2 [14.4] years; 104 [43.9%] women; mean [SD] baseline 25-hydroxyvitamin D level, 20.9 [9.2] ng/mL). Median (interquartile range) length of stay was not significantly different between the vitamin D3 (7.0 [4.0-10.0] days) and placebo groups (7.0 [5.0-13.0] days) (log-rank P=.59; unadjusted hazard ratio for hospital discharge, 1.07 [95% CI, 0.82-1.39]; P=.62). The difference between the vitamin D3 group and the placebo group was not significant for in-hospital mortality (7.6% vs 5.1%; difference, 2.5% [95% CI, –4.1% to 9.2%]; P=.43), admission to the intensive care unit (16.0% vs 21.2%; difference, –5.2% [95% CI, –15.1% to 4.7%]; P=.30), or need for mechanical ventilation (7.6% vs 14.4%; difference, –6.8% [95% CI, –15.1% to 1.2%]; P=.09). Mean serum levels of 25-hydroxyvitamin D significantly increased after a single dose of vitamin D3 vs placebo (44.4 ng/mL vs 19.8 ng/mL; difference, 24.1 ng/mL [95% CI, 19.5-28.7]; P<.001). There were no adverse events, but an episode of vomiting was associated with the intervention.

Conclusions and Relevance  Among hospitalized patients with COVID-19, a single high dose of vitamin D3, compared with placebo, did not significantly reduce hospital length of stay. The findings do not support the use of a high dose of vitamin D3 for treatment of moderate to severe COVID-19.

DOI: 10.1001/jama.2020.26848

Source: https://jamanetwork.com/journals/jama/fullarticle/2776738

期刊信息

JAMA-Journal of The American Medical Association:《美国医学会杂志》,创刊于1883年。隶属于美国医学协会,最新IF:51.273
官方网址:https://jamanetwork.com/
投稿链接:http://manuscripts.jama.com/cgi-bin/main.plex