Effect of microneedle design on pain in human volunteers.
Effect of microneedle design on pain in human volunteers.
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DOI：
10.1097/ajp.0b013e31816778f9
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发表时间：
2008-09
期刊：
影响因子：
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通讯作者：
Prausnitz MR
中科院分区：
文献类型：
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作者：
Gill HS;Denson DD;Burris BA;Prausnitz MR
为了设计将疼痛降至最低的微针，这项研究测试了这样一种假设，即微针引起的疼痛显著低于26号皮下注射针，并且减少微针长度和微针数量可以减少正常人的疼痛。在一项双盲随机研究中，将长度为480~1450μm、宽度为160~465μm、厚度为30~100μm、尖角为20°~90°的单根微针以及包含5根或50根微针的阵列植入10名健康受试者的前臂掌侧。视觉模拟评分疼痛评分被记录下来，并相互比较，并与26号皮下注射针的疼痛进行比较。所有研究的微针都明显比皮下注射针疼痛要轻，微针疼痛分数从皮下注射针的5%到40%不等。微针长度对疼痛的影响最大，长度增加三倍，疼痛评分增加七倍。微针的数量也影响了疼痛评分，其中微针数量增加10倍会使疼痛增加两倍多。微针顶端角度、厚度和宽度对疼痛无显著影响。在所研究的维度范围内，微针明显比26号皮下注射针疼痛更少。减少微针长度和微针数量可以减轻疼痛。
To design microneedles that minimize pain, this study tested the hypothesis that microneedles cause significantly less pain than a 26-gage hypodermic needle, and that decreasing microneedle length and the number of microneedles reduces pain in normal human subjects. Single microneedles with lengths ranging from 480 to 1450 μm, widths from 160 to 465 μm, thicknesses from 30 to 100 μm and tip angles from 20° to 90°; and arrays containing 5 or 50 microneedles were inserted into the volar forearms of ten healthy, human subjects in a double-blinded, randomized study. Visual analog scale pain scores were recorded and compared to each other and to the pain from a 26-gage hypodermic needle. All microneedles investigated were significantly less painful than the hypodermic needle with microneedle pain scores varying from 5 to 40% of the hypodermic needle. Microneedle length had the strongest effect on pain, where a three-fold increase in length increased the pain score by seven fold. The number of microneedles also affected the pain score, where a 10-fold increase in the number of microneedles increased pain just over two-fold. Microneedle tip angle, thickness and width did not significantly influence pain. Microneedles are significantly less painful than a 26-gage hypodermic needle over the range of dimensions investigated. Decreasing microneedle length and number of microneedles reduces pain.