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维生素 D 补充对儿童肺结核发热和咳嗽缓解的影响:印度尼西亚的一项随机双盲对照试验。

Effects of Vitamin D supplementation on resolution of fever and cough in children with pulmonary tuberculosis: A randomized double-blind controlled trial in Indonesia.

机构信息

Department of Child Health, Faculty of Medicine, Universitas Padjadjaran, Bandung, West Java, Indonesia.

Bethesda Serukam Hospital, Bengkayang, West Borneo, Indonesia.

出版信息

J Glob Health. 2022 Feb 18;12:04015. doi: 10.7189/jogh.12.04015. eCollection 2022.

DOI:10.7189/jogh.12.04015
PMID:35198149
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8855907/
Abstract

BACKGROUND

Various studies in adults have shown a strong association between vitamin D and tuberculosis (TB), both in terms of vitamin D status and the benefits of vitamin D in managing TB. Studies on vitamin D and its relationship with childhood TB still lack in Indonesia as a country with the second-highest TB incidence globally. This study evaluated the effect of vitamin D supplementation on resolution of cough and fever in Indonesian children with pulmonary TB.

METHODS

We conducted a randomized controlled trial of vitamin D supplementation in children with pulmonary TB and vitamin D insufficiency. Patients were randomly allocated with 1:1 ratio to receive either 1000 IU vitamin D or placebo daily after starting standard TB treatment. The primary outcome in this study was the resolution of fever and cough symptoms reviewed weekly after starting the treatment until the symptoms are resolved. The secondary outcome in this study was 25-hydroxyvitamin D serum level and nutritional status which was reviewed at the end of the trial. Intention to treat analyses were applied. Differences in clinical outcomes between two groups were calculated using Mann-Whitney U test or χ test, where appropriate.

FINDINGS

A total of 84 patients met the inclusion criteria, aged 6 to 18 years old, newly diagnosed with pulmonary TB and vitamin D insufficiency. Eighty patients (95,2%) completed the six months follow-up. Faster resolution of fever, cough, improved malnutrition status, and higher vitamin D level were found in the intervention group compared to the placebo group (all  < 0.001).

CONCLUSIONS

Vitamin D is beneficial in improving fever and cough resolution, and improving nutritional status in children with pulmonary TB and vitamin D insufficiency. Determination of adequate supplementation levels of more than 1000 IU requires further research to achieve normal vitamin D levels during the duration of treatment for pulmonary TB in children.

TRIAL REGISTRATION

ClinicalTrials.gov (NCT05073965).

摘要

背景

多项成人研究表明,维生素 D 状态与维生素 D 治疗结核病(TB)的益处之间均与结核病(TB)密切相关。在全球结核病发病率第二高的印度尼西亚,有关维生素 D 及其与儿童结核病关系的研究仍然缺乏。本研究评估了维生素 D 补充剂对印度尼西亚儿童肺结核患者咳嗽和发热消退的影响。

方法

我们对维生素 D 缺乏的肺结核儿童进行了维生素 D 补充的随机对照试验。患者在开始标准 TB 治疗后,按 1:1 的比例随机分配,每天接受 1000IU 维生素 D 或安慰剂。本研究的主要结局是治疗开始后每周评估一次发热和咳嗽症状的消退情况,直至症状消退。本研究的次要结局是 25-羟维生素 D 血清水平和营养状况,在试验结束时进行评估。采用意向治疗分析。使用 Mann-Whitney U 检验或 χ 检验(视情况而定)计算两组间临床结局的差异。

发现

共有 84 名符合纳入标准的患者,年龄在 6 至 18 岁之间,新诊断为肺结核且维生素 D 不足。80 名患者(95.2%)完成了 6 个月的随访。与安慰剂组相比,干预组发热、咳嗽更快消退,营养不良状况改善,维生素 D 水平更高(均<0.001)。

结论

维生素 D 可改善发热和咳嗽缓解,改善维生素 D 不足的肺结核儿童的营养状况。为了使儿童肺结核治疗期间的维生素 D 水平达到正常,需要进一步研究确定超过 1000IU 的充足补充量。

试验注册

ClinicalTrials.gov(NCT05073965)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c436/8855907/54b9db766bf5/jogh-12-04015-F1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c436/8855907/54b9db766bf5/jogh-12-04015-F1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c436/8855907/54b9db766bf5/jogh-12-04015-F1.jpg

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