Humanitas San Pio X Clinic, Milan, Italy.
Cantabria Labs Difa Cooper Medical Direction, Viale Milano 160, Caronno Pertusella, VA, Italy.
Photodiagnosis Photodyn Ther. 2020 Jun;30:101758. doi: 10.1016/j.pdpdt.2020.101758. Epub 2020 Apr 12.
Conventional photodynamic therapy (cPDT) is considered a very effective treatment of actinic keratosis (AK) lesions. However, its use is limited by the fact that this procedure could be very painful. The use of topical anesthetics such as tetracaine or lignocaine/prilocaine has shown disappointing results in term of pain reduction. A self-occlusive topical 7% lidocaine/7% tetracaine anesthetic cream (LT-C) approved by the FDA to provide local topical anesthesia in adults undergoing superficial dermatological procedures is available. There are no data regarding its pain reducing effect during cPDT. We perform a prospective, randomized, single-blind, two-center trial (The 3P-Trial) to assess the pain reduction effect of LT-C versus vehicle in subjects with AK undergoing cPDT.
Fifty AK subjects (74 ± 10 years, 32 men, 18 women) with on average 17 lesions were enrolled after their written informed consent. Eight subjects presented also a total of 16 basal cell carcinoma lesions. Twenty-five were randomized to LT-cream, applied 1 h before the Methyl amino levulinate (MAL)-cPDT session and 25 to cream vehicle. The main outcome was the patient-assessed evaluation of pain score during and just after the conclusion of cPDT session (mean of the two values) using a 10-point visual analog scale (VAS). The cPDT session (LED Red light 630 nm) was performed with a duration of 6 ± 2 min with a standard fluence of 37 J/cm2. All treated lesions were prepared by gentle superficial curettage.
All the randomized subjects concluded the trial. The mean ± SD of VAS score in vehicle group was 6.2 ± 2.7 (95 % CI of the mean: 5.0-7.5). In the group treated with LT-cream the VAS score was 3.3 ± 1.9 (95 % CI of the mean: 2.5-4.1). The active cream reduced the VAS score by 47 %. Median values of pain VAS score in the active group was reduced by 60 % in comparison with vehicle group (3.0 vs 7.5). The difference between the two groups was statistically significant (p = 0.0009; Mann-Whitney test).
The 3P-trial has demonstrated that the preventive application of the self-occlusive lidocaine 7%-tetracaine 7% cream is very effective in reducing the procedure-associated pain during MAL-cPDT for the treatment of AK lesions.
传统光动力疗法（cPDT）被认为是治疗光化性角化病（AK）病变的非常有效的方法。然而，其使用受到这样一个事实的限制，即该过程可能非常痛苦。局部麻醉剂如丁卡因或利多卡因/丙胺卡因的使用在减轻疼痛方面的效果并不理想。FDA 批准的一种自闭塞性 7%利多卡因/7%丁卡因麻醉乳膏（LT-C）可用于在接受浅表皮肤手术的成年人中提供局部局部麻醉。目前尚无关于其在 cPDT 中减轻疼痛效果的数据。我们进行了一项前瞻性、随机、单盲、双中心试验（3P 试验），以评估 AK 患者接受 cPDT 治疗时，LT-C 与载体相比减轻疼痛的效果。
50 名 AK 受试者（74±10 岁，32 名男性，18 名女性）在书面知情同意后纳入研究，平均有 17 个病变。8 名受试者还共出现了 16 个基底细胞癌病变。25 名随机分为 LT-乳膏组，在 Methyl amino levulinate（MAL）-cPDT 治疗前 1 小时应用，并将 25 名受试者随机分为乳膏载体组。主要结局是使用 10 分视觉模拟量表（VAS）评估患者在 cPDT 治疗期间和治疗结束后即刻的疼痛评分（两个值的平均值）。cPDT 治疗（630nm LED 红光）持续 6±2 分钟，标准剂量为 37J/cm2。所有治疗的病变均采用温和的浅表刮除术进行准备。
所有随机入组的受试者均完成了试验。载体组的 VAS 评分平均值为 6.2±2.7（均值的 95%置信区间：5.0-7.5）。在接受 LT-乳膏治疗的组中，VAS 评分为 3.3±1.9（均值的 95%置信区间：2.5-4.1）。活性乳膏可使 VAS 评分降低 47%。与载体组相比，活性组的疼痛 VAS 评分中位数降低了 60%（3.0 与 7.5）。两组间差异具有统计学意义（p=0.0009；Mann-Whitney 检验）。
3P 试验表明，预防性应用自闭塞性 7%利多卡因/7%丁卡因乳膏可有效减轻 MAL-cPDT 治疗 AK 病变过程中的相关疼痛。
