Novosanis, Bijkhoevelaan 32c, BE-2110 Wijnegem, Belgium; Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, BE-2610 Wilrijk, Belgium.
Department of Biomedical Sciences, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, BE-2610 Wilrijk, Belgium.
Vaccine. 2020 Jan 22;38(4):763-768. doi: 10.1016/j.vaccine.2019.11.002. Epub 2019 Nov 22.
In the context of precision medicine and in response to the highly needed capacity of rapid interventions towards new infectious diseases and pandemic outbreaks, intradermal immunization is gaining increased attention. However, the currently used Mantoux technique for ID injection is difficult to standardize and requires training, especially when used in children. To allow determining the maximum penetration depth and needle characteristics for the development of a platform of medical devices suited for intradermal injection, VAX-ID® and to ensure an accurate ID injection in children, the epidermal and dermal thickness at the proximal ventral and dorsal forearm (PVF & PDF) and at the deltoid region in children aged 8 weeks to 18 years were assessed. The lateral part of the upper leg was assessed as well in children aged 8 weeks to 2 years since it is a commonly used injection site in this population.
MATERIALS & METHODS: Mean thickness of the PVF, PDF, lateral part of the upper leg and deltoid were measured using high-frequency ultrasound. Association with gender, age and BMI was assessed using Mann-Whitney U Test, Spearman correlation and Wilcoxon Signed Ranks Test, respectively.
Results showed an overall mean skin thickness of 0.99 mm (SD: 0.14 mm) at the PVF, 1.20 mm (SD: 0.17) at the PDF, 1.28 mm (SD: 0.16) at the lateral part of the upper leg and increasing to 1.32 mm (0.25) at the deltoid region. Age and BMI correlated significantly (p < 0.001) with skin thickness at all investigated body sites. Gender did not affect skin thickness in the investigated population.
Significant differences in skin thickness at the PVF, PDF and deltoid region were seen according to age and BMI. An optimal needle length of 0.7 mm is advised to guarantee intradermal injection in children at all investigated injection sites. (NCT02727114).
在精准医学的背景下，为了应对新传染病和大流行病爆发时对快速干预措施的迫切需求，皮内免疫受到了越来越多的关注。然而，目前用于皮内注射的 Mantoux 技术难以标准化，需要进行专门培训，尤其是在儿童中使用时。为了确定可用于皮内注射的医疗器械平台的最大穿透深度和针具特性，并确保在儿童中进行准确的皮内注射，我们评估了 8 周至 18 岁儿童近侧掌侧和背侧前臂（PVF 和 PDF）以及三角肌区域的表皮和真皮厚度。还评估了 8 周至 2 岁儿童的小腿外侧部分，因为这是该人群中常用的注射部位。
使用高频超声测量 PVF、PDF、小腿外侧和三角肌的平均厚度。使用曼-惠特尼 U 检验、Spearman 相关分析和 Wilcoxon 符号秩检验分别评估性别、年龄和 BMI 与厚度的相关性。
结果显示，PVF 的平均皮肤厚度为 0.99mm（标准差：0.14mm），PDF 为 1.20mm（标准差：0.17mm），小腿外侧为 1.28mm（标准差：0.16mm），三角肌区域逐渐增加至 1.32mm（0.25mm）。年龄和 BMI 与所有研究部位的皮肤厚度均呈显著相关（p<0.001）。性别在研究人群中对皮肤厚度无影响。
在 PVF、PDF 和三角肌区域，根据年龄和 BMI 观察到皮肤厚度存在显著差异。建议使用 0.7mm 的最佳针长，以保证在所有研究的注射部位对儿童进行皮内注射。（NCT02727114）。
