早期高剂量维生素D3治疗危重病、维生素D缺乏患者并不优于安慰剂
作者：
小柯机器人 发布时间：2019/12/17 16:37:56
高剂量维生素D3早期治疗危重症、维生素D缺乏的患者，这一成果由美国科罗拉多大学医学院Adit Ginde团队取得。 2019年12月11日，《新英格兰医学杂志》发表了这项成果。
维生素D缺乏是危重病患者发病和死亡的一类常见、潜在的可逆因素。但急性危重病补充维生素D的潜在益处仍需进一步研究。
研究组进行了一项随机、双盲、安慰剂对照、临床3期试验，对高死亡风险的危重病、维生素D缺乏患者补充维生素D3。经测试检验，共招募了1078名基础维生素D缺乏的患者，进入重症监护病房后12小时内随机分组，分别接受单次肠内注射54万IU维生素D3或相匹配的安慰剂。
治疗3天后，维生素D组的25-羟基维生素D的平均水平为46.9±23.2ng/ml，安慰剂组为11.4±5.6ng/ml。维生素D组的90天死亡率为23.5%，安慰剂组为20.6%。两组间的其他临床观察指标均无显著性差异。
总之，早期采用大剂量维生素D3治疗危重病、维生素D缺乏的患者，90天死亡率或其他非致命性结局均不优于安慰剂。
附：英文原文
Title: Early High-Dose Vitamin D3 for Critically Ill, Vitamin D–Deficient Patients
Author: The National Heart, Lung, and Blood Institute PETAL Clinical Trials Network
Issue&Volume: 2019-12-11
Abstract:
Background
Vitamin D deficiency is a common, potentially reversible contributor to morbidity and mortality among critically ill patients. The potential benefits of vitamin D supplementation in acute critical illness require further study.
Methods
We conducted a randomized, double-blind, placebo-controlled, phase 3 trial of early vitamin D3 supplementation in critically ill, vitamin D–deficient patients who were at high risk for death. Randomization occurred within 12 hours after the decision to admit the patient to an intensive care unit. Eligible patients received a single enteral dose of 540,000 IU of vitamin D3 or matched placebo. The primary end point was 90-day all-cause, all-location mortality.
Results
A total of 1360 patients were found to be vitamin D–deficient during point-of-care screening and underwent randomization. Of these patients, 1078 had baseline vitamin D deficiency (25-hydroxyvitamin D level, <20 ng per milliliter [50 nmol per liter]) confirmed by subsequent testing and were included in the primary analysis population. The mean day 3 level of 25-hydroxyvitamin D was 46.9±23.2 ng per milliliter (117±58 nmol per liter) in the vitamin D group and 11.4±5.6 ng per milliliter (28±14 nmol per liter) in the placebo group (difference, 35.5 ng per milliliter; 95% confidence interval [CI], 31.5 to 39.6). The 90-day mortality was 23.5% in the vitamin D group (125 of 531 patients) and 20.6% in the placebo group (109 of 528 patients) (difference, 2.9 percentage points; 95% CI, ?2.1 to 7.9; P=0.26). There were no clinically important differences between the groups with respect to secondary clinical, physiological, or safety end points. The severity of vitamin D deficiency at baseline did not affect the association between the treatment assignment and mortality.
Conclusions
Early administration of high-dose enteral vitamin D3 did not provide an advantage over placebo with respect to 90-day mortality or other, nonfatal outcomes among critically ill, vitamin D–deficient patients. (Funded by the National Heart, Lung, and Blood Institute; VIOLET ClinicalTrials.gov number, NCT03096314.)
DOI: 10.1056/NEJMoa1911124
Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1911124
