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轻度分割显著提高浅层基底细胞癌对氨基酮戊酸光动力疗法的反应:一项随机、前瞻性试验的 5 年随访。

Light fractionation significantly improves the response of superficial basal cell carcinoma to aminolaevulinic acid photodynamic therapy: five-year follow-up of a randomized, prospective trial.

机构信息

Department of Dermatology, Erasmus MC, PO box 2040, 3000 CA Rotterdam, The Netherlands.

出版信息

Acta Derm Venereol. 2012 Nov;92(6):641-7. doi: 10.2340/00015555-1448.

DOI:10.2340/00015555-1448
PMID:22964973
Abstract

Photodynamic therapy (PDT) using topical porphyrin-precursors is a promising treatment for superficial basal cell carcinoma (sBCC), but it needs further optimization. The aim of this study was to compare 5-year lesion (complete) response rates of sBCC treated with topical aminolaevulinic acid (ALA)-PDT using a single illumination vs. ALA-PDT using a 2-fold illumination scheme. A prospective, randomized study was performed, in which 91 patients with 299 lesions were treated with a 2-fold illumination scheme with 2 light fractions of 20 and 80 J/cm2 delivered 4 and 6 h after a single application of 20% ALA, and 106 patients with 274 lesions were treated with a single illumination of 75 J/cm2 4 h after a single application of 20% ALA. All lesions were treated at a fluence rate of 50 mW/cm2. An interim time to event analysis of complete response (CR) rates at 12 months showed encouraging results, and therefore lesions were followed for 5 years post-therapy. A third group of 50 patients with 172 lesions treated with 2-fold illumination were included after the initial period and analysed separately. The CR rate was significantly greater following the 2-fold illumination than the single illumination (p = 0.0002, log-rank test). Five years after therapy the CR rate after 2-fold illumination was 88%, whereas the CR rate after single illumination was 75%. The CR rate in the third group of lesions, treated with 2-fold illumination was 97% and 88% at 12 months and 5 years after therapy, respectively. Long-term follow-up indicates superior efficacy in sBCC of ALA-PDT with 2-fold illumination compared with ALA-PDT with single illumination.

摘要

光动力疗法(PDT)使用局部卟啉前体是治疗浅表基底细胞癌(sBCC)的一种很有前途的方法,但需要进一步优化。本研究的目的是比较局部 5-氨基酮戊酸(ALA)-PDT 单次照射与 ALA-PDT 两次照射方案治疗 sBCC 的 5 年病变(完全)反应率。进行了一项前瞻性、随机研究,91 例 299 处病变患者采用 2 倍光照射方案治疗,在单次应用 20%ALA 后 4 和 6 小时分别给予 20 和 80 J/cm2 两个光剂量,106 例 274 处病变患者采用单次 75 J/cm2 照射,在单次应用 20%ALA 后 4 小时进行照射。所有病变的辐照率均为 50 mW/cm2。12 个月时完全反应(CR)率的中间时间事件分析结果令人鼓舞,因此在治疗后 5 年对病变进行了随访。在初始阶段后,又纳入了第三组 50 例 172 处病变患者,采用 2 倍光照射,单独进行分析。2 倍光照射组的 CR 率明显高于单次光照射组(p=0.0002,对数秩检验)。治疗 5 年后,2 倍光照射组的 CR 率为 88%,而单次光照射组的 CR 率为 75%。第三组病变(2 倍光照射)的 CR 率在治疗后 12 个月和 5 年时分别为 97%和 88%。长期随访表明,与单次光照射相比,2 倍光照射的 ALA-PDT 治疗 sBCC 的疗效更优。

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