Haschke Ferdinand, Steenhout Philipp, Grathwohl Dominik, Haschke-Becher Elisabeth
Nestle Nutrition Institute, Vevey, Switzerland.
World Rev Nutr Diet. 2013;106:33-8. doi: 10.1159/000342559. Epub 2013 Feb 11.
Growth studies are necessary to prove safety and efficacy of new or renovated infant formulas. Healthy infants need to be followed in randomized clinical trials until 4-6 months of age. Breastfed reference groups should be included in such studies, because growth of formula-fed infants may deviate from breastfed infants. The WHO growth standard describes growth of exclusively or predominantly breastfed infants and is frequently used as reference. However, the limitations of the standard must be known because weight-for-age until 6 months is higher than in all international growth references. Meta-analyses indicate that both weight and BMI of breastfed reference groups in clinical trials and of infants fed a low protein formula are somehow lower than the WHO standard. Infants of overweight and obese mothers or at risk for malnutrition are considered as at-risk populations. Any infant formula trial in those populations should use the WHO standard to document safety.
生长研究对于证明新的或改良的婴儿配方奶粉的安全性和有效性是必要的。健康婴儿需要在随机临床试验中随访至4至6个月龄。此类研究应纳入母乳喂养参考组，因为配方奶喂养婴儿的生长情况可能与母乳喂养婴儿不同。世界卫生组织生长标准描述了纯母乳喂养或主要母乳喂养婴儿的生长情况，常被用作参考。然而，必须了解该标准的局限性，因为6个月龄前的年龄别体重高于所有国际生长参考标准。荟萃分析表明，临床试验中母乳喂养参考组以及喂养低蛋白配方奶粉婴儿的体重和体重指数均略低于世界卫生组织标准。超重和肥胖母亲的婴儿或有营养不良风险的婴儿被视为高危人群。在这些人群中进行的任何婴儿配方奶粉试验都应使用世界卫生组织标准来证明安全性。
