维生素 D3 补充剂治疗呼吸道感染频繁发作的患者：一项随机、双盲干预研究。
Vitamin D3 supplementation in patients with frequent respiratory tract infections: a randomised and double-blind intervention study.
机构信息
Department of Laboratory Medicine, Clinical Microbiology, Karolinska Institutet, Stockholm, Sweden.
出版信息
BMJ Open. 2012 Dec 13;2(6). doi: 10.1136/bmjopen-2012-001663. Print 2012.
BACKGROUND
Low serum levels of 25-hydroxyvitamin D(3) are associated with an increased risk of respiratory tract infections (RTIs). Clinical trials with vitamin D(3) against various infections have been carried out but data are so far not conclusive. Thus, there is a need for additional randomised controlled trials of effects of vitamin D(3) on infections.
OBJECTIVE
To investigate if supplementation with vitamin D(3) could reduce infectious symptoms and antibiotic consumption among patients with antibody deficiency or frequent RTIs.
DESIGN
A double-blind randomised controlled trial.
SETTING
Karolinska University Hospital, Huddinge.
PARTICIPANTS
140 patients with antibody deficiency (selective IgA subclass deficiency, IgG subclass deficiency, common variable immune disorder) and patients with increased susceptibility to RTIs (>4 bacterial RTIs/year) but without immunological diagnosis.
INTERVENTION
Vitamin D(3) (4000 IU) or placebo was given daily for 1 year.
PRIMARY AND SECONDARY OUTCOME MEASURES
The primary endpoint was an infectious score based on five parameters: symptoms from respiratory tract, ears and sinuses, malaise and antibiotic consumption. Secondary endpoints were serum levels of 25-hydroxyvitamin D(3), microbiological findings and levels of antimicrobial peptides (LL-37, HNP1-3) in nasal fluid.
RESULTS
The overall infectious score was significantly reduced for patients allocated to the vitamin D group (202 points) compared with the placebo group (249 points; adjusted relative score 0.771, 95% CI 0.604 to 0.985, p=0.04).
LIMITATIONS
A single study centre, small sample size and a selected group of patients. The sample size calculation was performed using p=0.02 as the significance level whereas the primary and secondary endpoints were analysed using the conventional p=0.05 as the significance level.
CONCLUSIONS
Supplementation with vitamin D(3) may reduce disease burden in patients with frequent RTIs.
背景
血清 25-羟维生素 D(3) 水平低与呼吸道感染 (RTI) 风险增加有关。已经进行了维生素 D(3) 针对各种感染的临床试验，但到目前为止数据尚无定论。因此，需要进行更多的维生素 D(3) 对感染影响的随机对照试验。
目的
研究补充维生素 D(3) 是否可以减少抗体缺陷或经常发生 RTI 的患者的感染症状和抗生素消耗。
设计
双盲随机对照试验。
地点
卡罗林斯卡大学医院，胡丁厄。
参与者
140 名抗体缺陷患者（选择性 IgA 亚类缺陷、IgG 亚类缺陷、常见可变免疫障碍）和易患 RTI 增加的患者（>4 次细菌 RTI/年）但无免疫诊断。
干预措施
维生素 D(3)（4000 IU）或安慰剂每天服用 1 年。
主要和次要结果测量
主要终点是基于五个参数的感染评分：呼吸道、耳朵和鼻窦症状、不适和抗生素消耗。次要终点是血清 25-羟维生素 D(3) 水平、微生物学发现和鼻液中抗菌肽 (LL-37、HNP1-3) 水平。
结果
与安慰剂组（249 分）相比，分配给维生素 D 组的患者的整体感染评分显著降低（202 分；调整后的相对评分 0.771，95%CI 0.604 至 0.985，p=0.04）。
局限性
一个研究中心、样本量小和选择的患者群体。样本量计算使用 p=0.02 作为显著性水平进行，而主要和次要终点使用传统的 p=0.05 作为显著性水平进行分析。
结论
补充维生素 D(3) 可能会减轻经常发生 RTI 的患者的疾病负担。
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