Wang I, Bendsoe N, Klinteberg C A, Enejder A M, Andersson-Engels S, Svanberg S, Svanberg K
Departments of Oncology and Dermatology and Venereology, Lund University Hospital, SE-221 85 Lund, Sweden.
Br J Dermatol. 2001 Apr;144(4):832-40. doi: 10.1046/j.1365-2133.2001.04141.x.
A previously reported randomized clinical trial showed treatment of Bowen's disease using photodynamic therapy (PDT) with topically applied delta-aminolaevulinic acid (ALA) to be at least as effective as cryosurgery and to be associated with fewer adverse effects.
To compare ALA-PDT and cryotherapy in the treatment of histopathologically verified basal cell carcinomas (BCCs) in a non-blinded, prospective phase III clinical trial.
One lesion from each of 88 patients was included. The BCCs were divided into superficial and nodular lesions. The follow-up period was restricted to 1 year with close follow-up for the first 3 months. Efficacy was assessed as the recurrence rate 12 months after the first treatment session, verified by histopathology. Tolerability was evaluated as the time of healing, pain and discomfort during and after the treatment, and final cosmetic outcome.
Histopathologically verified recurrence rates in the two groups were statistically comparable and were 25% (11 of 44) for ALA-PDT and 15% (six of 39) for cryosurgery. However, clinical recurrence rates were only 5% (two of 44) for PDT and 13% (five of 39) for cryosurgery. Additional treatments, usually one, had to be performed in 30% of the lesions in the PDT group. The healing time was considerably shorter and the cosmetic outcome significantly better with PDT. Pain and discomfort during the treatment session and in the following week were low, and were equivalent with the two treatment modalities.
In terms of efficacy, ALA-PDT is comparable with cryosurgery as a treatment modality for BCCs. Retreatments are more often required with PDT than with cryosurgery. This can easily be performed due to the shorter healing time, less scarring and better cosmetic outcome that follows ALA-PDT.
先前一项随机临床试验表明，使用外用δ-氨基乙酰丙酸（ALA）的光动力疗法（PDT）治疗鲍恩病至少与冷冻手术效果相当，且不良反应更少。
在一项非盲法前瞻性III期临床试验中比较ALA-PDT与冷冻疗法治疗经组织病理学证实的基底细胞癌（BCC）的效果。
纳入88例患者，每个患者的一个病灶。将BCC分为浅表性和结节性病变。随访期限制为1年，前3个月密切随访。疗效评估为首次治疗后12个月的复发率，通过组织病理学验证。耐受性评估为愈合时间、治疗期间及之后的疼痛和不适，以及最终的美容效果。
两组经组织病理学证实的复发率在统计学上具有可比性，ALA-PDT组为25%（44例中的11例），冷冻手术组为15%（39例中的6例）。然而，PDT组的临床复发率仅为5%（44例中的2例），冷冻手术组为13%（39例中的5例）。PDT组30%的病灶需要进行额外治疗，通常为一次。PDT的愈合时间明显更短，美容效果显著更好。治疗期间及随后一周的疼痛和不适程度较低，两种治疗方式相当。
在疗效方面，ALA-PDT作为BCC的一种治疗方式与冷冻手术相当。与冷冻手术相比，PDT更常需要再次治疗。由于ALA-PDT后的愈合时间更短、瘢痕更少且美容效果更好，再次治疗很容易进行。
