Fowler Joseph F, Zax Robert H
University of Louisville School of Medicine, Kentucky, USA.
Cutis. 2002 Jun;69(6 Suppl):2-7.
The safety and efficacy of treating individuals who presented with multiple actinic keratosis (AK) lesions with 5-aminolevulinic acid (ALA) in combination with photodynamic therapy (PDT) were documented in a phase III trial. This report highlights results of this phase III trial and reviews 4 specific cases of sustained AK lesion clearance 4 years after treatment with ALA/PDT Long-term recurrence data were collected from patients who participated in clinical trials of ALA/PDT Long-term evaluation extended to 36 to 48 months (4 years) supports primary efficacy findings of the phase III pivotal trial, with a low incidence of AK recurrence in patients treated with ALA/PDT
一项III期试验记录了用5-氨基酮戊酸(ALA)联合光动力疗法(PDT)治疗患有多发性光化性角化病(AK)皮损个体的安全性和有效性。本报告重点介绍了该III期试验的结果,并回顾了4例ALA/PDT治疗4年后AK皮损持续清除的具体病例。从参与ALA/PDT临床试验的患者中收集长期复发数据。长达36至48个月(4年)的长期评估支持了III期关键试验的主要疗效结果,接受ALA/PDT治疗的患者中AK复发率较低