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分激光介导的光动力疗法治疗高危基底细胞癌——一项随机临床试验。

Fractional laser-mediated photodynamic therapy of high-risk basal cell carcinomas--a randomized clinical trial.

机构信息

Department of Dermatology, D-92, Bispebjerg Hospital, University of Copenhagen, Bispebjerg Bakke 23, DK-2400, Copenhagen NV, Denmark; Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, U.S.A.

出版信息

Br J Dermatol. 2015 Jan;172(1):215-22. doi: 10.1111/bjd.13166. Epub 2014 Nov 30.

DOI:10.1111/bjd.13166
PMID:24903544
Abstract

BACKGROUND

Photodynamic therapy (PDT) is approved for selected nodular basal cell carcinomas (nBCC) but efficacy is reduced for large and thick tumours. Ablative fractional lasers (AFXL) facilitate uptake of methyl aminolaevulinate (MAL) and may thus improve PDT outcome.

OBJECTIVES

To evaluate efficacy and safety of AFXL-mediated PDT (AFXL-PDT) compared with conventional PDT of high-risk nBCC.

METHODS

Patients with histologically verified facial nBCC (n = 32) defined as high-risk tumours were included; diameter > 15 mm, tumours located in high-risk zones, or on severely sun-damaged skin. Tumours were debulked and patients randomized to either AFXL-PDT (n = 16) or PDT (n = 16). Fractional CO2 laser treatment was applied at 5% density and 1000 μm (80 mJ) ablation depth. MAL was applied under occlusion for 3 h and illuminated with a 633-nm light-emitting diode source, 37 J cm(-2) . Clinical assessments were performed at 3, 6, 9 and 12 months and biopsies were taken at 12 months.

RESULTS

Clinical cure rates at 3 months were 100% (16 of 16 AFXL-PDT) and 88% (14 of 16 PDT, P = 0·484). Recurrences tended to occur later and in lower numbers after AFXL-PDT at 6, 9 and 12 months (6%, 19%, 19%) than PDT (25%, 38%, 44%) (P = 0·114). Histology at 12 months documented equal tumour clearance after AFXL-PDT (63%, 10 of 16) and PDT (56%, 9 of 16). Cosmetic outcomes were highly satisfactory after both treatments (P > 0·090).

CONCLUSIONS

Long-term efficacy was similar after PDT and AFXL-PDT with a trend for a favourable short-term cure rate after AFXL-PDT. AFXL-PDT needs further refinement for nBCC and at present is not recommended over PDT.

摘要

背景

光动力疗法(PDT)已被批准用于治疗某些结节性基底细胞癌(nBCC),但对于大型和厚型肿瘤,疗效降低。消融性分数激光(AFXL)可促进甲氨基酮戊酸(MAL)的吸收,从而可能改善 PDT 效果。

目的

评估 AFXL 介导的 PDT(AFXL-PDT)与高危 nBCC 的常规 PDT 相比的疗效和安全性。

方法

纳入经组织学证实的面部 nBCC(n=32)患者;直径>15mm,肿瘤位于高危区域,或位于严重日光损伤的皮肤。肿瘤被切除,患者随机分为 AFXL-PDT(n=16)或 PDT(n=16)组。应用 5%密度和 1000μm(80mJ)消融深度的分数 CO2 激光治疗。MAL 经闭塞 3 小时应用,并以 633nm 发光二极管光源,37J/cm2 进行光照。在 3、6、9 和 12 个月进行临床评估,并在 12 个月进行活检。

结果

3 个月时的临床治愈率为 100%(16/16AFXL-PDT)和 88%(14/16PDT,P=0.484)。AFXL-PDT 后 6、9 和 12 个月的复发率较低(6%、19%、19%),而 PDT 后(25%、38%、44%)(P=0.114)。12 个月的组织学显示,AFXL-PDT(63%,16/16)和 PDT(56%,16/16)的肿瘤清除率相等。两种治疗方法的美容效果均非常满意(P>0.090)。

结论

PDT 和 AFXL-PDT 的长期疗效相似,AFXL-PDT 有短期治愈率高的趋势。AFXL-PDT 尚需进一步改进,目前不推荐用于治疗 nBCC。

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