Papas Konstantinos A, Sontag Marci K, Pardee Churee, Sokol Ronald J, Sagel Scott D, Accurso Frank J, Wagener Jeffrey S
Yasoo Health, Johnson City, TN, USA.
J Cyst Fibros. 2008 Jan;7(1):60-7. doi: 10.1016/j.jcf.2007.05.001. Epub 2007 Jun 13.
Pancreatic insufficiency and a diminished bile acid pool cause malabsorption of important essential nutrients and other dietary components in cystic fibrosis (CF). Of particular significance is the malabsorption of fat-soluble antioxidants such as carotenoids, tocopherols and coenzyme Q(10) (CoQ(10)). Despite supplementation, CF patients are often deficient in these compounds, resulting in increased oxidative stress, which may contribute to adverse health effects. This pilot study was designed to evaluate the safety of a novel micellar formulation (CF-1) of fat-soluble nutrients and antioxidants and to determine its efficacy in improving plasma levels of these compounds and reducing inflammatory markers in induced sputum.
Ten CF subjects, ages 8 to 45 years old, were given orally 10 ml of the CF-1 formulation daily for 56 days after a 21-day washout period in which subjects stopped supplemental vitamin use except for a standard multivitamin. Plasma obtained at -3, 0 (baseline), 1, 2, 4, and 8 weeks was assayed for beta-carotene, gamma-tocopherol, retinol, and CoQ(10) as well as for safety parameters (comprehensive metabolic panel and complete blood count). In addition, pulmonary function was measured and induced sputum was assayed for markers of inflammation and quantitative bacterial counts both prior and during dosing.
No serious adverse effects, laboratory abnormalities or elevated nutrient levels (above normal) were identified as related to CF-1. Supplementation with CF-1 significantly increased beta-carotene levels at all dosing time points when compared to screening and baseline. In addition, gamma-tocopherol and CoQ(10) significantly increased from baseline in all subjects. Induced sputum myeloperoxidase significantly decreased and there was a trend toward decreases in PMN elastase and total cell counts with CF-1. There was a significant inverse correlation between the antioxidant levels and induced sputum changes in IL-8 and total neutrophils. Lung function and sputum bacterial counts were unchanged.
The novel CF-1 formulation safely and effectively increased plasma levels of important fat-soluble nutrients and antioxidants. In addition, improvements in antioxidant plasma levels were associated with reductions in airway inflammation in CF patients.
胰腺功能不全和胆汁酸池减少会导致囊性纤维化（CF）患者对重要必需营养素和其他饮食成分的吸收不良。脂溶性抗氧化剂如类胡萝卜素、生育酚和辅酶Q10（CoQ10）的吸收不良尤为显著。尽管进行了补充，但CF患者往往缺乏这些化合物，导致氧化应激增加，这可能对健康产生不利影响。这项初步研究旨在评估一种新型脂溶性营养素和抗氧化剂胶束制剂（CF-1）的安全性，并确定其在提高这些化合物的血浆水平和降低诱导痰中炎症标志物方面的疗效。
10名年龄在8至45岁之间的CF受试者，在21天的洗脱期后，每天口服10毫升CF-1制剂，持续56天。洗脱期内，受试者除服用标准多种维生素外，停止使用补充维生素。在第-3、0（基线）、1、2、4和8周采集血浆，检测β-胡萝卜素、γ-生育酚、视黄醇和CoQ10以及安全参数（综合代谢指标和全血细胞计数）。此外，在给药前和给药期间测量肺功能，并检测诱导痰中的炎症标志物和定量细菌计数。
未发现与CF-1相关的严重不良反应、实验室异常或营养素水平升高（高于正常）。与筛查和基线相比，补充CF-1在所有给药时间点均显著提高了β-胡萝卜素水平。此外，所有受试者的γ-生育酚和CoQ10均较基线显著增加。CF-1使诱导痰髓过氧化物酶显著降低，PMN弹性蛋白酶和总细胞计数有下降趋势。抗氧化剂水平与诱导痰中IL-8和总中性粒细胞的变化之间存在显著负相关。肺功能和痰细菌计数未改变。
新型CF-1制剂安全有效地提高了重要脂溶性营养素和抗氧化剂的血浆水平。此外，抗氧化剂血浆水平的改善与CF患者气道炎症的减轻有关。
