Clinical administration of microneedles: skin puncture, pain and sensation
Clinical administration of microneedles: skin puncture, pain and sensation
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DOI：
10.1007/s10544-008-9208-1
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发表时间：
2009-02-01
影响因子：
2.8
通讯作者：
Birchall, J. C.
中科院分区：
文献类型：
--
作者：
Haq, M. I.;Smith, E.;Birchall, J. C.
使用皮下注射针头进行注射会引起疼痛、不适、局部创伤和恐惧。此外，需要小心使用和处置针头，以避免传播血液传播的病原体。作为替代方案，微针可以促进药物递送，而不会显著影响位于皮肤外层下方的疼痛感受器或血管。在这项研究中，我们的目的是确定应用湿蚀刻硅微针时的疼痛和感觉反应，以可靠地穿透皮肤的方式使用，并提供皮肤如何随着时间的推移对微针损伤的反应的初步指示。12名受试者接受了25-G皮下注射针和两个微针阵列（36个180和280 μ m高的针）的单盲插入。微针应用的最佳方法在试点研究中确定。使用视觉模拟量表（VAS）对疼痛强度进行评分，并使用改良的麦吉尔疼痛问卷简表确定感觉。通过外部染色和测量经表皮水分损失（TEWL）来确定皮肤渗透。平均VAS评分、口头描述和问卷回答显示，180和280 μ m微针在参与者中引起的疼痛和不适感明显低于皮下注射针。亚甲基蓝染色和TEWL分析证实，微针应用后，在皮肤中形成微通道。微通道修复和再密封的证据在应用后8-24小时是明显的。总之，这项研究表明，金字塔形湿法蚀刻微针可以穿透人体皮肤，疼痛和感觉不适最小，为潜在的药物，疫苗和DNA递送创造短暂的途径。
Injections using hypodermic needles cause pain, discomfort, localised trauma and apprehension. Additionally, careful use and disposal of needles is required to avoid transmission of blood-borne pathogens. As an alternative, microneedles can facilitate drug delivery without significantly impacting on pain receptors or blood vessels that reside beneath the skin outer layers. In this study we aim to determine the pain and sensory response to the application of wet-etch silicon microneedles, when used in such a way as to reliably penetrate skin, and provide a preliminary indication of how skin responds to microneedle injury with time. Twelve subjects received single-blinded insertions of a 25-G hypodermic needle and two microneedle arrays (36 needles of 180 and 280 mu m height). The optimal method for microneedle application was determined in a pilot study. Pain intensity was scored using a visual analogue scale (VAS) and sensory perception determined using an adapted McGill Pain Questionnaire Short Form. Skin penetration was determined by external staining and measurement of trans-epidermal water loss (TEWL). Mean VAS scores, verbal descriptions and questionnaire responses showed that the 180 and 280 mu m microneedles caused significantly less pain and discomforting sensation in participants than the hypodermic needle. Methylene blue staining and TEWL analysis confirmed that microchannels were formed in the skin following microneedle application. Evidence of microchannel repair and resealing was apparent at 8-24 h post-application. In summary, this study shows that pyramidal wet-etch microneedles can penetrate human skin with minimal pain and sensory discomfort, creating transient pathways for potential drug, vaccine and DNA delivery.