Stender I M, Na R, Fogh H, Gluud C, Wulf H C
Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark.
Lancet. 2000 Mar 18;355(9208):963-6. doi: 10.1016/S0140-6736(00)90013-8.
Photodynamic therapy (PDT) with topical 5-aminolaevulinic acid (ALA) followed by irradiation with incoherent light (ALA-PDT) for recalcitrant warts have had beneficial results. Therefore, we undertook a randomised, parallel, double-blind clinical trial of ALA-PDT versus placeboPDT for recalcitrant foot and hand warts.
Recalcitrant foot and hand warts were randomly assigned to six repetitive ALA-PDT or placebo-PDT interventions combined with standard treatment encompassing paring followed by a keratolytic (Verucid). Standardised photographs of each wart were taken before, during (week 7) and after treatment (weeks 14 and 18). The area of each wart compared with entry area was the primary outcome variable, measured from photographs by an evaluator unaware of treatment allocation for intervention. Pain intensity immediately and 24 h after each intervention was assessed by a five-point scale.
A total of 232 foot and hand warts in 45 patients were entered into the trial: 117 warts were allocated to ALA-PDT and 115 warts to placebo-PDT. In week 14, the median relative reduction in wart area was 98% in the ALA-PDT group (interquartile range 100%, 55%) versus 52% (100%, 0) in the placebo group (p=0.0006). In week 18, the median relative reduction in wart area was 100% in the ALA-PDT group (100%, 57%) versus 71% (100%, 0) in the placebo-PDT arm (p=0.008). Both the number of vanishing warts and the difference in relative wart area of persisting warts at week 14 and 18 were significant (p<0.05) in favour of ALA-PDT. Significantly more ALA-PDT warts were graded at a higher pain intensity after treatment than placebo-PDT warts.
ALA-PDT is superior to placebo-PDT when both wart area and number of vanishing warts are considered.
采用外用5-氨基酮戊酸（ALA）进行光动力疗法（PDT），随后用非相干光照射（ALA-PDT）治疗顽固性疣已取得了有益的效果。因此，我们开展了一项关于ALA-PDT与安慰剂PDT治疗顽固性手足疣的随机、平行、双盲临床试验。
顽固性手足疣被随机分配接受6次重复的ALA-PDT或安慰剂-PDT干预，并结合包括削除术随后使用角质剥脱剂（Verucid）的标准治疗。在治疗前、治疗期间（第7周）以及治疗后（第14周和第18周）拍摄每个疣的标准化照片。将每个疣与初始面积相比的面积作为主要结局变量，由一名不知道治疗分配情况的评估者根据照片进行测量。每次干预后立即以及24小时后的疼痛强度采用五点量表进行评估。
45例患者共232个手足疣纳入试验：117个疣分配至ALA-PDT组，115个疣分配至安慰剂-PDT组。在第14周，ALA-PDT组疣面积的中位相对减少率为98%（四分位间距为100%，55%），而安慰剂组为52%（100%，0）（p=0.0006）。在第18周，ALA-PDT组疣面积的中位相对减少率为100%（100%，57%），而安慰剂-PDT组为71%（100%，0）（p=0.008）。在第14周和第18周，消失的疣的数量以及持续存在的疣的相对面积差异均具有统计学意义（p<0.05），支持ALA-PDT。治疗后，ALA-PDT组的疣疼痛强度分级显著高于安慰剂-PDT组。
当同时考虑疣面积和消失的疣的数量时，ALA-PDT优于安慰剂-PDT。
