一项针对7岁以上苯丙酮尿症儿童的特殊食品“比非尼兰”的临床研究结果

T. P. Zhukova, S. Ratnikova, N. A. Irinina, E.S. Zaytseva, N.B. Sedova
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引用次数: 0

摘要

目标。评价一种专门用于膳食治疗营养的食品“比非尼兰”对7岁以上苯丙酮尿症儿童的疗效、安全性和耐受性。患者和方法。在门诊临床环境中进行了一项开放标签前瞻性研究。17例8 ~ 15岁的苯丙酮尿症患儿(女孩12例,男孩5例),接受专用产品“比非尼兰”治疗30±2天。在研究开始和结束时评估临床和记忆特征、荧光法测定的血液苯丙氨酸水平。结果。在研究期间,血液中苯丙氨酸水平显著下降,并在参考范围内(研究前中位数为9.11 mg/dL,研究结束时中位数为6.17 mg/dL, p < 0.05)。同时,在苯丙氨酸水平最初升高的儿童中,苯丙氨酸水平下降到可接受的范围内,在苯丙氨酸水平正常的儿童中,苯丙氨酸水平保持在相同的范围内。患者、他们的父母和医生对该产品的使用完全满意,该产品耐受性良好,过渡到该产品后没有适应期。结论。一种专门用于膳食治疗营养的食品“比非尼兰”对7岁以上苯丙酮尿症儿童的有效性、安全性和良好的耐受性得到了证实。关键词:儿童,食疗营养专用食品,苯丙氨酸,苯丙酮尿症
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Results of a clinical study of a specialized food product for dietary therapeutic nutrition “Bifinilan” for children over seven years of age with phenylketonuria
Objective. To evaluate the efficacy, safety, and tolerability of a specialized food product for dietary therapeutic nutrition “Bifinilan” in children over 7 years of age with phenylketonuria. Patients and methods. An open-label prospective study was conducted in outpatient clinical settings. It included 17 children with phenylketonuria aged between 8 and 15 years (12 girls and 5 boys), who received a specialized product “Bifinilan” for 30 ± 2 days. Clinical and anamnestic characteristics, blood phenylalanine levels determined by the fluorescent method were assessed at the beginning and at the end of the study. Results. During the study, blood phenylalanine levels decreased significantly and were within the reference range (median before the study was 9.11 mg/dL, at the end of the study – 6.17 mg/dL, p < 0.05). At the same time, in children with initially elevated phenylalanine level, it decreased to an acceptable range, and in children with a normal phenylalanine level, it remained within the same range. Patients, their parents, and physicians were completely satisfied with the use of the product, which was well tolerated and the transition to which was not followed by an adaptation period. Conclusion. The efficacy, safety, and good tolerability of a specialized food product for dietary therapeutic nutrition “Bifinilan” in children over 7 years of age with phenylketonuria was demonstrated. Key words: children, specialized food product for dietary therapeutic nutrition, phenylalanine, phenylketonuria
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来源期刊
Voprosy Detskoi Dietologii
Voprosy Detskoi Dietologii Medicine-Pediatrics, Perinatology and Child Health
CiteScore
1.20
自引率
0.00%
发文量
17
期刊介绍: The scientific journal Voprosy Detskoi Dietologii is included in the Scopus database. Publisher country is RU. The main subject areas of published articles are Food Science, Pediatrics, Perinatology, and Child Health, Nutrition and Dietetics, Клиническая медицина.
期刊最新文献
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