一项产前维生素D平喘试验的六年随访
2020/10/14
摘要
背景：我们之前曾报道过一项产前补充维生素D预防幼儿哮喘和反复发作的喘息的试验结果，表明维生素D对3岁儿童具有保护作用。我们随访这些儿童到6岁，以确定哮喘和反复发作的喘息的病程。
方法：在该项随访研究中，研究者和参与者在孩子六岁生日时仍不知治疗任务。我们的目的是确定，当考虑到母亲体内25-羟基维生素D水平时，孕期每天摄入4400IU维生素D3的母亲(维生素D组)所生的孩子在6岁时是否会比每天摄入400IU维生素D3的母亲(对照组)所生的孩子在6岁时哮喘和反复发作的喘息的发病率更低。采用时间—事件分析法比较治疗组哮喘发作或反复喘息发作的时间。采用多变量分析方法比较治疗组间肺功能的纵向测量值。
结果：无论是意向治疗分析还是根据孕妇孕期25-羟基维生素D水平分层分析，母亲补充维生素D对哮喘和反复发作的喘息均无影响。产前补充维生素D对大多数预定的次要结局无影响。我们发现产前补充对肺活量指数无影响。尽管脉冲振荡法测量对气道阻力影响很小，但这一发现的意义尚不确定。
结论：单独在产前补充维生素D并不影响有哮喘风险的儿童6年内哮喘和反复发作的喘息的发生率。
Six-Year Follow-up of a Trial of Antenatal Vitamin D for Asthma Reduction
Augusto A Litonjua, Vincent J Carey, Nancy Laranjo, Benjamin J Stubbs, Hooman Mirzakhani, George T O'Connor, Megan Sandel, Avraham Beigelman, Leonard B Bacharier, Robert S Zeiger, Michael Schatz, Bruce W Hollis, Scott T Weiss.
Abstract
BACKGROUND:We previously reported the results of a trial of prenatal vitamin D supplementation to prevent asthma and recurrent wheeze in young children, which suggested that supplementation provided a protective effect at the age of 3 years. We followed the children through the age of 6 years to determine the course of asthma and recurrent wheeze.
METHODS:In this follow-up study, investigators and participants remained unaware of the treatment assignments through the children's sixth birthday. We aimed to determine whether, when maternal levels of 25-hydroxyvitamin D were taken into account, children born to mothers who had received 4400 IU of vitamin D3 per day during pregnancy (vitamin D group) would have a lower incidence of asthma and recurrent wheeze at the age of 6 years than would those born to mothers who had received 400 IU of vitamin D3 per day (control group). Time-to-event methods were used to compare the treatment groups with respect to time to the onset of asthma or recurrent wheeze. Multivariate methods were used to compare longitudinal measures of lung function between the treatment groups.
RESULTS:There was no effect of maternal vitamin D supplementation on asthma and recurrent wheeze in either an intention-to-treat analysis or an analysis with stratification according to the maternal 25-hydroxyvitamin D level during pregnancy. There was no effect of prenatal vitamin D supplementation on most of the prespecified secondary outcomes. We found no effects of prenatal supplementation on spirometric indexes. Although there was a very small effect on airway resistance as measured by impulse oscillometry, this finding was of uncertain significance.
CONCLUSIONS:Vitamin D supplementation during the prenatal period alone did not influence the 6-year incidence of asthma and recurrent wheeze among children who were at risk for asthma.
背景：我们之前曾报道过一项产前补充维生素D预防幼儿哮喘和反复发作的喘息的试验结果，表明维生素D对3岁儿童具有保护作用。我们随访这些儿童到6岁，以确定哮喘和反复发作的喘息的病程。
方法：在该项随访研究中，研究者和参与者在孩子六岁生日时仍不知治疗任务。我们的目的是确定，当考虑到母亲体内25-羟基维生素D水平时，孕期每天摄入4400IU维生素D3的母亲(维生素D组)所生的孩子在6岁时是否会比每天摄入400IU维生素D3的母亲(对照组)所生的孩子在6岁时哮喘和反复发作的喘息的发病率更低。采用时间—事件分析法比较治疗组哮喘发作或反复喘息发作的时间。采用多变量分析方法比较治疗组间肺功能的纵向测量值。
结果：无论是意向治疗分析还是根据孕妇孕期25-羟基维生素D水平分层分析，母亲补充维生素D对哮喘和反复发作的喘息均无影响。产前补充维生素D对大多数预定的次要结局无影响。我们发现产前补充对肺活量指数无影响。尽管脉冲振荡法测量对气道阻力影响很小，但这一发现的意义尚不确定。
结论：单独在产前补充维生素D并不影响有哮喘风险的儿童6年内哮喘和反复发作的喘息的发生率。
(中日友好医院呼吸与危重症医学科 王静茹 摘译 林江涛 审校)
(N Engl J Med.2020,382(6):525-533.doi: 10.1056/NEJMoa1906137.)
(N Engl J Med.2020,382(6):525-533.doi: 10.1056/NEJMoa1906137.)
Six-Year Follow-up of a Trial of Antenatal Vitamin D for Asthma Reduction
Augusto A Litonjua, Vincent J Carey, Nancy Laranjo, Benjamin J Stubbs, Hooman Mirzakhani, George T O'Connor, Megan Sandel, Avraham Beigelman, Leonard B Bacharier, Robert S Zeiger, Michael Schatz, Bruce W Hollis, Scott T Weiss.
Abstract
BACKGROUND:We previously reported the results of a trial of prenatal vitamin D supplementation to prevent asthma and recurrent wheeze in young children, which suggested that supplementation provided a protective effect at the age of 3 years. We followed the children through the age of 6 years to determine the course of asthma and recurrent wheeze.
METHODS:In this follow-up study, investigators and participants remained unaware of the treatment assignments through the children's sixth birthday. We aimed to determine whether, when maternal levels of 25-hydroxyvitamin D were taken into account, children born to mothers who had received 4400 IU of vitamin D3 per day during pregnancy (vitamin D group) would have a lower incidence of asthma and recurrent wheeze at the age of 6 years than would those born to mothers who had received 400 IU of vitamin D3 per day (control group). Time-to-event methods were used to compare the treatment groups with respect to time to the onset of asthma or recurrent wheeze. Multivariate methods were used to compare longitudinal measures of lung function between the treatment groups.
RESULTS:There was no effect of maternal vitamin D supplementation on asthma and recurrent wheeze in either an intention-to-treat analysis or an analysis with stratification according to the maternal 25-hydroxyvitamin D level during pregnancy. There was no effect of prenatal vitamin D supplementation on most of the prespecified secondary outcomes. We found no effects of prenatal supplementation on spirometric indexes. Although there was a very small effect on airway resistance as measured by impulse oscillometry, this finding was of uncertain significance.
CONCLUSIONS:Vitamin D supplementation during the prenatal period alone did not influence the 6-year incidence of asthma and recurrent wheeze among children who were at risk for asthma.
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