首例人体试验：纳米电化学消融治疗基底细胞癌——方法验证。
First-in-human trial of nanoelectroablation therapy for basal cell carcinoma: proof of method.
机构信息
BioElectroMed Corp., Burlingame, CA, USA.
出版信息
Exp Dermatol. 2014 Feb;23(2):135-7. doi: 10.1111/exd.12303. Epub 2014 Jan 23.
Abstract
This nanoelectroablation therapy effectively treats subdermal murine allograft tumors, autochthonous basal cell carcinoma (BCC) tumors in Ptch1+/-K14-Cre-ER p53 fl/fl mice, and UV-induced melanomas in C57/BL6 HGF/SF mice. Here, we described the first human trial of this modality. We treated 10 BCCs on three subjects with 100-1000 electric pulses 100 ns in duration, 30 kV/cm in amplitude, applied at 2 pulses per second. Seven of the 10 treated lesions were completely free of basaloid cells when biopsied and two partially regressed. Two of the 7 exhibited seborrheic keratosis in the absence of basaloid cells. One of the 10 treated lesions recurred by week 10 and histologically had the appearance of a squamous cell carcinoma. No scars were visible at the healed sites of any of the successfully ablated lesions. One hundred pulses were sufficient for complete ablation of BCCs with a single, 1-min nanoelectroablation treatment.
摘要
这种纳米电消融疗法可有效治疗皮下鼠异体移植物肿瘤、Ptch1+/-K14-Cre-ER p53fl/fl 小鼠中的自发性基底细胞癌 (BCC) 肿瘤，以及 C57/BL6 HGF/SF 小鼠中的 UV 诱导黑素瘤。在此，我们描述了该方法的首次人体试验。我们对 3 名受试者的 10 个 BCC 进行了治疗，每个病变部位施加 100-1000 个持续 100ns、幅度为 30kV/cm 的电脉冲，每秒施加 2 个脉冲。在活检时，10 个治疗病变中有 7 个完全没有基底层细胞，2 个部分消退。7 个中有 2 个表现为脂溢性角化病，没有基底层细胞。在 10 个治疗病变中有 1 个在第 10 周复发，组织学上表现为鳞状细胞癌。在任何成功消融的病变的愈合部位均看不到疤痕。单次 1 分钟的纳米电消融治疗即可用 100 个脉冲完成 BCC 的完全消融。
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