Department of Pediatrics, The Children's Hospital, University of Colorado Denver School of Medicine, Aurora, CO, USA.
J Cyst Fibros. 2011 Jan;10(1):31-6. doi: 10.1016/j.jcf.2010.09.005. Epub 2010 Oct 20.
Despite supplementation with standard multivitamins and pancreatic enzymes, deficiencies of vitamins D and K and antioxidants are common in cystic fibrosis (CF).
In this non-randomized, open-label study, AquADEKs® softgels were given daily over 12 weeks to 14 CF subjects (mean age 15 years, range 10-23) without a preceding wash-out period. Both pancreatic sufficient and insufficient subjects were enrolled. Plasma vitamin and antioxidant levels, urine 8-isoprostane levels, anthropometric measures, and pulmonary function were determined at baseline, 6 and 12 weeks.
Daily supplementation significantly increased plasma beta(β)-carotene, coenzyme Q10, and γ-tocopherol concentrations, decreased proteins induced in vitamin K absence (PIVKA-II) levels, but did not normalize vitamin D and K status in all subjects. Vitamin A levels did not exceed the normal range for any subject during the entire study period. Modest improvements in weight percentile and pulmonary function were observed. Change in plasma β-carotene concentrations weakly correlated with changes in weight and body mass index percentiles.
In this study, AquADEKs® increased systemic antioxidant levels, while maintaining vitamin A levels in the normal range, and improved but did not completely normalize vitamin D and K status. Increased β-carotene levels were associated with improved growth parameters. These results warrant further clinical evaluation in CF.
尽管补充了标准的多种维生素和胰腺酶,囊性纤维化(CF)患者仍普遍存在维生素 D 和 K 以及抗氧化剂缺乏。
在这项非随机、开放标签研究中,14 名 CF 患者(平均年龄 15 岁,范围 10-23 岁)在没有洗脱期的情况下,每日服用 AquADEKs®软胶囊,持续 12 周。纳入了胰腺功能充分和不足的患者。在基线、6 周和 12 周时,测定血浆维生素和抗氧化剂水平、尿 8-异前列腺素水平、人体测量指标和肺功能。
每日补充显著增加了血浆 β-胡萝卜素、辅酶 Q10 和 γ-生育酚浓度,降低了维生素 K 缺乏诱导的蛋白质(PIVKA-II)水平,但并未使所有患者的维生素 D 和 K 状态正常化。在整个研究期间,没有任何患者的维生素 A 水平超过正常值。观察到体重百分位数和肺功能有适度改善。血浆 β-胡萝卜素浓度的变化与体重和体重指数百分位数的变化呈弱相关。
在这项研究中,AquADEKs®增加了全身抗氧化剂水平,同时使维生素 A 水平保持在正常范围内,并改善了但并未完全使维生素 D 和 K 状态正常化。β-胡萝卜素水平的增加与生长参数的改善相关。这些结果值得在 CF 中进一步临床评估。