BACKGROUND: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. METHODS: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. RESULTS: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. CONCLUSION: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.

译文

背景:胰腺功能不全和胆汁酸池减少导致囊性纤维化(CF)中重要的必需营养素和其他饮食成分吸收不良。特别重要的是脂溶性抗氧化剂,如类胡萝卜素,生育酚和辅酶Q(10)(CoQ(10))的吸收不良。尽管进行了补充,但CF患者通常缺乏这些化合物,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脂溶性营养物质和抗氧化剂的新型胶束制剂(CF-1)的安全性,并确定其在改善这些化合物的血浆水平和减少诱导痰中的炎性标志物方面的功效。
方法:在21天的清除期后的56天内,每天对10位年龄在8至45岁的CF受试者口服10 ml的CF-1制剂,持续56天,在此期间受试者停止补充维生素的使用,但标准的多种维生素除外。测定在-3、0(基准),1、2、4和8周时获得的血浆中的β-胡萝卜素,γ-生育酚,视黄醇和CoQ(10)以及安全性参数(全面的代谢检查和完整血球计数)。另外,在给药之前和给药期间,测量肺功能并测定诱导痰中的炎症标志物和定量细菌计数。
结果:未发现与CF-1相关的严重不良反应,实验室异常或营养水平升高(高于正常水平)。与筛选和基线相比,在所有给药时间点补充CF-1都会显着增加β-胡萝卜素的水平。此外,所有受试者的γ-生育酚和辅酶Q(10)均较基线显着增加。诱导的痰髓过氧化物酶显着减少,并且CFN导致PMN弹性蛋白酶和总细胞数减少。 IL-8和总中性粒细胞的抗氧化剂水平与诱导的痰液变化之间存在显着的负相关。肺功能和痰细菌计数不变。
结论:新型CF-1制剂可安全有效地增加血浆中重要脂溶性营养素和抗氧化剂的含量。另外,抗氧化剂血浆水平的改善与CF患者气道炎症的减轻有关。

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