González Jiménez David, Bousoño García Carlos, Díaz Martin Juan Jose, Jiménez Treviño Santiago
Sección de Gastroenterología, Hepatología y Nutrición Pediátrica, AGC de Pediatría, Hospital Universitario Central de Asturias, Oviedo. España..
Nutr Hosp. 2015 Apr 1;31(4):1625-32. doi: 10.3305/nh.2015.31.4.8281.
Evaluate the safety and efficacy of a novel polyvitaminic (Aquadek's®) in patients with Cystic Fibrosis (CF).
Prospective, longitudinal and non-randomized study. CF patients with pancreatic insufficiency and clinically stable were given Aquadek's® (two chewable tablets) daily for 12 months. Serum levels of retinol, beta-carotene, 25 OH vitamin D and α-tocopherol were evaluated twelve months before, at baseline and 12 months after.
paired t tests.
28 patients aged 6 to 39 years (median 18.5 years) were included. Aquadek's® supplementation led to an increase in vitamin A dose and a decrease in the number of tablets administered. At baseline, 89% had at least one vitamin deficiency (61% pro-Vitamin A and 54% vitamin D). After one year, serum beta-carotene levels were increases 160 (95% CI 98-222) mcg/l (p <0.001) and decreased the percentage of patients with pro-vitamin A deficiency 46% (95% CI 22-64) (p <0.001). The proportion of patients with vitamin D insuficiency increased 18%(95% CI 2-32) (p =0.025). In any case serum levels exceeded the upper limits used to assess the risk of toxicity.Conclusions: Two daily Aquadek's® chewable tablets are safe and effective for maintaining vitamin A and E status of CF patients older than 6 years, although it is insufficient to normalize serum 25OHvitaminD according to the current recommendations for this disease.
评估一种新型多种维生素制剂(Aquadek's®)对囊性纤维化(CF)患者的安全性和有效性。
前瞻性、纵向、非随机研究。给予胰腺功能不全且临床稳定的CF患者每日服用Aquadek's®(两片咀嚼片),持续12个月。在给药前12个月、基线期及给药后12个月评估血清视黄醇、β-胡萝卜素、25-羟基维生素D和α-生育酚水平。
配对t检验。
纳入28例年龄在6至39岁(中位数18.5岁)的患者。补充Aquadek's®导致维生素A剂量增加,且服用片数减少。基线时,89%的患者至少存在一种维生素缺乏(61%为维生素A原缺乏,54%为维生素D缺乏)。一年后,血清β-胡萝卜素水平升高160(95%可信区间98 - 222)mcg/l(p<0.001),维生素A原缺乏患者的比例降低46%(95%可信区间22 - 64)(p<0.001)。维生素D不足患者的比例增加18%(95%可信区间2 - 32)(p = 0.025)。无论如何,血清水平均超过用于评估毒性风险的上限。结论:每日两片Aquadek's®咀嚼片对于维持6岁以上CF患者的维生素A和E水平是安全有效的,尽管根据针对该疾病的当前建议,它不足以使血清25-羟基维生素D恢复正常。