在人类受试者中,压电微针电波器的耐受性
Chao-Yi Lu1, Pankaj Rohilla2, Eric I Felner2,3
1Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University, Georgia Institute of Technology Atlanta Georgia USA.
Bioengineering & translational medicine
|July 22, 2024
概括
使用微针电穿孔的ePatch设备在人体试验中显示出出色的患者耐受性和最小的疼痛. 这种手持设备为DNA和mRNA疫苗的输送提供了一个舒适的替代方案.
科学领域:
- 生物医学工程 生物医学工程
- 免疫学 免疫学 免疫学
- 皮肤病学 皮肤病学
背景情况:
- 电穿孔增强了DNA/mRNA疫苗的免疫性,但面临临临床翻译障碍.
- 传统的电阻器是昂贵的,重的,复杂的,由于神经刺激,耐受性很差.
- ePatch是一个新的,低成本的,手持式电穿孔器,使用微针来改善细胞内输送.
研究的目的:
- 为了评估ePatch设备在人类中的耐受性和患者舒适性.
- 为了测试ePatch的微针阵列将神经刺激降到最低,并提高舒适度的假设.
- 与传统方法相比,评估与ePatch电穿孔相关的不良影响.
主要方法:
- 进行了一项涉及14名健康成年人的试验,以评估ePatch的耐受性.
- 在ePatch应用后,对疼痛感知和不良反应 (红血,胀) 进行了监测.
- 使用安慰剂ePatch来控制与电穿孔无关的效应.
主要成果:
- 应用ePatch比传统的皮下注射针插入要少痛苦.
- 副作用是最小的,短暂的,在ePatch和安慰剂之间统计学上相似.
- 在实验组和安慰剂组之间没有观察到疼痛,疼痛,红疹或胀的显著差异.
结论:
- ePatch在人类中表现出良好的耐受性概况.
- 微针阵列将电场定位,减少神经刺激,提高舒适度.
- ePatch具有在DNA和mRNA疫苗接种和治疗中安全和舒适的临床使用的潜力.
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