Jessica S Johnson, Jackson Hanna, Amy S Nowacki, Sanjay Anand, Alan S Shen, Edward V Maytin
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引用次数: 0
摘要
背景：传统的红光光动力疗法治疗光化性角化病（AK）会在光照下引起明显的疼痛。目的：评价短潜伏期红光PDT新方案的疼痛和疗效特点。方法：面部AK患者（n = 30例）采用10% ALA凝胶（无遮挡）加红光（635 nm）治疗，随机分组后如下[潜伏期、光照时间（光照强度）]:A组[10 min、20 min (74 J/cm2)]；B组[20 min， 10 min (37 J/cm2)]；C组[1小时，10分钟（37 J/cm2）]。在间隔8周的两次PDT治疗期间记录疼痛和AK病变计数。最终病变计数在3-6个月。结果：在两次就诊时，A组和B组患者的疼痛可忽略不计，统计学上小于C组患者。两种PDT治疗后的AK清除率在三个治疗组中是稳健且相似的（A组76%，B组74%，C组82%）。使用15%的非劣效裕度，在一次PDT治疗后，a组的病变减少在统计学上不逊于C组。局限性：新的短孵育方案（无遮挡）的有效率没有直接与fda批准的长孵育方案（3小时）进行比较。结论：短接触红光PDT方案基本上是无痛的，似乎提供了非常好的AK病变清除。临床试验注册：NCT06027619（试验注册日期：2023年8月31日）。
Painless PDT using 10% aminolevulinate gel and red light: A pilot clinical trial of short-contact protocols to reduce discomfort during illumination.
Background: Traditional red light photodynamic therapy for actinic keratoses (AK) causes significant pain during illumination.
Objective: To evaluate new short-incubation red light PDT regimens for their pain and efficacy characteristics.
Methods: Patients (n = 30) with facial AK were treated with 10% ALA gel (no occlusion) and red light (635 nm), after randomization as follows [incubation time, illumination time (fluence)]: Group A [10 min, 20 min (74 J/cm2)]; Group B [20 min, 10 min (37 J/cm2)]; Group C [1 hour, 10 min (37 J/cm2)]. Pain and AK lesion counts were recorded during two PDT treatments spaced 8 weeks apart. Final lesion counts were at 3-6 months.
Results: At both treatment visits, Group A and B patients experienced negligible pain that was statistically less than that of Group C patients. AK clearance after two PDT treatments was robust and similar amongst the three treatment groups (76% for Group A, 74% for Group B, and 82% for Group C). Using a non-inferiority margin of 15%, lesion reduction in Group A was statistically non-inferior to Group C after one PDT treatment.
Limitations: Efficacy rates of the new short incubation protocols (done without occlusion) were not compared directly with the long (3-hour) FDA-approved protocol that is done with occlusion.
Conclusion: Short-contact red light PDT regimens are essentially painless and appear to provide very good AK lesion clearance.
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