Effect of a soy isoflavone supplement on lung function and clinical outcomes in patients with poorly controlled asthma: a randomized clinical trial.
Effect of a soy isoflavone supplement on lung function and clinical outcomes in patients with poorly controlled asthma: a randomized clinical trial.
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DOI：
10.1001/jama.2015.5024
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发表时间：
2015-05-26
期刊：
影响因子：
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通讯作者：
American Lung Association Asthma Clinical Research Centers
中科院分区：
文献类型：
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作者：
Smith LJ;Kalhan R;Wise RA;Sugar EA;Lima JJ;Irvin CG;Dozor AJ;Holbrook JT;American Lung Association Asthma Clinical Research Centers
大豆异黄酮补充剂被用于治疗几种慢性疾病，尽管支持其使用的数据有限。一些数据表明，补充大豆异黄酮可能是治疗哮喘控制不佳患者的有效方法。确定大豆异黄酮补充剂是否能改善疾病控制不佳的青少年和成人哮喘患者的控制。多中心、随机、双盲、安慰剂对照试验于2010年5月至2012年8月在美国肺脏协会哮喘临床研究中心网络的19个成人和儿童肺部和过敏中心进行。386名患有哮喘症状的成人和12岁以上儿童在服用对照药物和低大豆饮食摄入时被随机分组，345人（89%）在第24周完成肺活量测定。参与者被随机分配接受含有100毫克总异黄酮的大豆异黄酮补充剂（n=193）或相匹配的安慰剂（n=193），每天分两次服用，持续24周。主要结局指标是24周时第一秒用力呼气量（FEV1）的变化。次要结局指标为症状、哮喘控制不良发作、哮喘控制测试评分（范围5-25分，评分越高表明控制越好）以及全身和气道炎症生物标志物。24周内，安慰剂组支气管扩张剂前FEV1平均变化为0.03 L (95% CI,−0.01 ~ 0.08 L)，大豆异黄酮组为0.01 L (95% CI,−0.07 ~ 0.07 L)，差异无统计学意义（P = 0.36）。哮喘控制试验中症状评分的平均变化(安慰剂，1.98 [95% CI, 1.42-2.54] vs大豆异黄酮，2.20 [95% CI, 1.53-2.87]；阳性值表明症状减轻)，哮喘控制不良发作次数（安慰剂，3.3 [95% CI, 2.7-4.1] vs大豆异黄酮，3.0 [95% CI, 2.4-3.7]）和呼出一氧化氮的变化（安慰剂，- 3.48 ppb [95% CI, - 5.99至- 0.97 ppb] vs大豆异黄酮，1.39 ppb [95% CI, - 1.73至4.51 ppb]）与大豆异黄酮补充剂相比，大豆异黄酮补充剂没有显著改善。在接受补充剂的参与者中，平均血浆染料木素水平从4.87 ng/mL增加到37.67 ng/mL （P < 0.001）。在哮喘控制不佳的成人和12岁以上儿童中，与安慰剂相比，使用大豆异黄酮补充剂并没有改善肺功能或临床结果。这些发现表明，这种补充剂不应用于控制不良的哮喘患者。
Soy isoflavone supplements are used to treat several chronic diseases, although the data supporting their use are limited. Some data suggest that supplementation with soy isoflavone may be an effective treatment for patients with poor asthma control. To determine whether a soy isoflavone supplement improves asthma control in adolescent and adult patients with poorly controlled disease. Multicenter, randomized, double-blind, placebo-controlled trial conducted between May 2010 and August 2012 at 19 adult and pediatric pulmonary and allergy centers in the American Lung Association Asthma Clinical Research Centers network. Three hundred eighty-six adults and children aged 12 years or older with symptomatic asthma while taking a controller medicine and low dietary soy intake were randomized, and 345 (89%) completed spirometry at week 24. Participants were randomly assigned to receive soy isoflavone supplement containing 100 mg of total isoflavones (n=193) or matching placebo (n=193) in 2 divided doses administered daily for 24 weeks. The primary outcome measure was change in forced expiratory volume in the first second (FEV1) at 24 weeks. Secondary outcome measures were symptoms, episodes of poor asthma control, Asthma Control Test score (range, 5–25; higher scores indicate better control), and systemic and airway biomarkers of inflammation. Mean changes in prebronchodilator FEV1 over 24 weeks were 0.03 L (95% CI, −0.01 to 0.08 L) in the placebo group and 0.01 L (95% CI, −0.07 to 0.07 L) in the soy isoflavone group, which were not significantly different (P = .36). Mean changes in symptom scores on the Asthma Control Test (placebo, 1.98 [95% CI, 1.42–2.54] vs soy isoflavones, 2.20 [95% CI, 1.53–2.87]; positive values indicate a reduction in symptoms), number of episodes of poor asthma control (placebo, 3.3 [95% CI, 2.7–4.1] vs soy isoflavones, 3.0 [95% CI, 2.4–3.7]), and changes in exhaled nitric oxide (placebo, −3.48 ppb [95% CI, −5.99 to −0.97 ppb] vs soy isoflavones, 1.39 ppb [95% CI, −1.73 to 4.51 ppb]) did not significantly improve more with the soy isoflavone supplement than with placebo. Mean plasma genistein level increased from 4.87 ng/mL to 37.67 ng/mL (P < .001) in participants receiving the supplement. Among adults and children aged 12 years or older with poorly controlled asthma while taking a controller medication, use of a soy isoflavone supplement, compared with placebo, did not result in improved lung function or clinical outcomes. These findings suggest that this supplement should not be used for patients with poorly controlled asthma.