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激光辅助光动力疗法治疗浅表基底细胞癌和 Bowen 病:连续和分数性消融 CO2 激光模式的患者内随机对照比较。

Laser-assisted photodynamic therapy for superficial basal cell carcinoma and Bowen's disease: a randomized intrapatient comparison between a continuous and a fractional ablative CO laser mode.

机构信息

Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.

Department of Dermatology, Ghent University Hospital, Ghent, Belgium.

出版信息

J Eur Acad Dermatol Venereol. 2018 Nov;32(11):1897-1905. doi: 10.1111/jdv.14989. Epub 2018 Jul 17.

DOI:10.1111/jdv.14989
PMID:29633367
Abstract

BACKGROUND

Laser-assisted photodynamic therapy is being explored as a method to enhance efficacy of photodynamic therapy (PDT).

OBJECTIVE

To compare a continuous (CL) and a fractional (FL) ablative CO laser-assisted methyl aminolevulinate (MAL) PDT in the management of superficial basal cell carcinoma (sBCC) and Bowen's disease (BD).

METHODS

Thirty treatment areas in fifteen patients with inoperable, histologically verified sBCC or BD received CL or FL after intrapatient randomization. Laser treatment was followed by MAL application and illumination occurred 3 h later. This treatment was repeated after 2 weeks. An equivalence analysis was performed on the primary endpoint efficacy, while secondary endpoints pain, side-effects and aesthetics were evaluated using paired samples tests. Patients were also asked for their preferred treatment.

RESULTS

An excellent efficacy of 92.9% (sBCC, 100%; BD, 80%) was found in both CL + PDT and FL + PDT after 12 months. Equivalence could not be established. Little pain was perceived in most patients during PDT illumination. PDT treatment in FL + PDT was less painful, significantly during the second treatment (P = 0.026). Side-effects were mild to moderate with erythema being the most frequent immediate side-effect, followed by oedema, crusting and burning sensation. Pigmentary changes occurred in 21% (CL + PDT) to 29% (FL + PDT), and aesthetics were good to excellent in all patients. CL + PDT and FL + PDT did not significantly differ in side-effects (P = 0.219-1.000) or aesthetics (P = 0.157-1.000).

CONCLUSIONS

Results in this pilot study support the promising role of laser-assisted PDT. Both treatment arms demonstrated the same efficacy as well as comparable side-effects and aesthetics. PDT illumination was significantly less painful in the FL + PDT group, suggesting a preference for FL + PDT. The authors recommend further investigation with a larger sample size, a subgroup analysis between sBCC and BD and comparison of different treatment protocols before one technique could be preferred to another.

摘要

背景

激光辅助光动力疗法正被探索用于提高光动力疗法(PDT)的疗效。

目的

比较连续(CL)和分数(FL)消融 CO2 激光辅助甲氨基酮戊酸(MAL)PDT 治疗浅表基底细胞癌(sBCC)和 Bowen 病(BD)的疗效。

方法

将 15 例不可手术的组织学证实的 sBCC 或 BD 患者的 30 个治疗区域进行患者内随机分组,分别接受 CL 或 FL 治疗。激光治疗后立即应用 MAL,3 小时后进行光照。2 周后重复该治疗。对主要终点疗效进行等效性分析,同时采用配对样本检验评估次要终点疼痛、副作用和美学效果。患者还被要求选择他们更喜欢的治疗方法。

结果

12 个月后,CL+PDT 和 FL+PDT 的疗效均达到 92.9%(sBCC 为 100%,BD 为 80%),但等效性无法建立。大多数患者在 PDT 光照过程中仅感到轻度疼痛。在 FL+PDT 中,治疗过程中的疼痛明显较轻,第二次治疗时差异具有统计学意义(P=0.026)。副作用为轻度至中度,最常见的即刻副作用为红斑,其次为水肿、结痂和烧灼感。色素沉着改变发生在 21%(CL+PDT)至 29%(FL+PDT)之间,所有患者的美学效果均良好至极好。CL+PDT 和 FL+PDT 在副作用(P=0.219-1.000)或美学效果(P=0.157-1.000)方面无显著差异。

结论

本初步研究结果支持激光辅助 PDT 的良好作用,两种治疗方法均具有相同的疗效,且副作用和美学效果相当。在 FL+PDT 组中,PDT 光照的疼痛明显较轻,提示患者更倾向于 FL+PDT。作者建议进一步开展更大样本量的研究,对 sBCC 和 BD 进行亚组分析,并比较不同的治疗方案,然后再确定一种优于另一种技术。

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