Hossain Md Monir, Jones Jennifer M, Dey Swatee, Carr Gregory J, Visscher Marty O
Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA.
Skin Sciences Program, Division of Pediatric Plastic Surgery, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA.
Food Chem Toxicol. 2015 Oct;84:106-14. doi: 10.1016/j.fct.2015.08.014. Epub 2015 Aug 15.
Exposure to topically applied substances occurs routinely in premature and hospitalized infant care. Safety determinations are most accurate when exposures are based on appropriately designed studies to capture variations in practice patterns and population heterogeneity. Current safety assessments may not reflect actual practice resulting in overly conservative or understated default assumptions for toxicological determinations. We quantified the amount of baby wipes lotion transferred to premature and term neonatal skin as grams/kg body weight/day. We observed the soil type and number of wipes used for skin cleansing and measured lotion transfer from one wipe applied to freshly clean, dry skin. A Bayesian imputation approach was applied to compute lotion exposure and produce summary statistics. Model covariates were age and weight at evaluation, gender, soil type, soil amount, and number of diaper changes per day. Lotion transfer was measured for 66 premature and 55 term neonates with 449 and 254 evaluations, respectively. The wipes per day was 12.52 overall (all infants and soils), 12.78 for premature and 12.21 for term neonates. Lotion transfer was 0.20 g/kg/day (95th percentile) overall, 0.21 for premature and 0.19 for term neonates. The statistical and experimental methodology represents an effective strategy for determining exposure and assessing risk.
在早产儿和住院婴儿护理中，经常会接触到局部应用的物质。当暴露情况基于适当设计的研究以捕捉实践模式的变化和人群异质性时，安全性判定最为准确。当前的安全性评估可能无法反映实际情况，从而导致毒理学判定的默认假设过于保守或低估。我们将婴儿湿巾乳液转移到早产和足月新生儿皮肤上的量量化为克/千克体重/天。我们观察了用于皮肤清洁的湿巾类型和数量，并测量了应用于刚清洁干燥皮肤的一张湿巾的乳液转移量。采用贝叶斯插补方法计算乳液暴露量并生成汇总统计数据。模型协变量包括评估时的年龄和体重、性别、湿巾类型、湿巾用量以及每天更换尿布的次数。分别对66名早产儿和55名足月新生儿进行了乳液转移量测量，评估次数分别为449次和254次。总体而言，每天使用的湿巾数量为12.52张（所有婴儿和所有湿巾类型），早产儿为12.78张，足月新生儿为12.21张。乳液转移量总体为0.20克/千克/天（第95百分位数），早产儿为0.21克/千克/天，足月新生儿为0.19克/千克/天。该统计和实验方法是确定暴露量和评估风险的有效策略。
