利多卡因2.5%与丙胺卡因2.5% eutetic混合物用于广泛头皮光化性角化病的5-氨基酮戊酸光动力疗法局部麻醉疗效的随机、双盲、安慰剂对照前瞻性研究。

Randomized, double-blind, placebo-controlled prospective study of the efficacy of topical anaesthesia with a eutetic mixture of lignocaine 2.5% and prilocaine 2.5% for topical 5-aminolaevulinic acid-photodynamic therapy for extensive scalp actinic keratoses.

作者信息

Langan S M, Collins P

机构信息

City of Dublin Skin and Cancer Hospital, Dublin 2, Ireland.

出版信息

Br J Dermatol. 2006 Jan;154(1):146-9. doi: 10.1111/j.1365-2133.2005.06991.x.

DOI:10.1111/j.1365-2133.2005.06991.x

PMID:16403108

Abstract

BACKGROUND

Photodynamic therapy (PDT) is an effective treatment modality for the treatment of extensive scalp actinic keratoses (AKs), but pain is a significant drawback when treating large areas with topical PDT using 5-aminolaevulinic acid (ALA) as sensitizer. A recent study has shown that use of tetracaine gel (Ametop) did not significantly reduce pain associated with PDT.

OBJECTIVES

To assess the benefit of a eutetic mixture of lignocaine 2.5% and prilocaine 2.5% (Emla) on pain during topical ALA-PDT treatment of scalp AKs.

METHODS

Fourteen men aged 59-83 years with extensive scalp AKs were recruited into a double-blind placebo-controlled study. Two treatment fields were defined (right and left frontal scalp) and were treated 2 weeks apart. These fields were randomized to receive either Emla or Aqueous cream as first or second treatment. ALA 20% cream was applied for 4 h. Topical anaesthesia or Aqueous cream was applied for 2 h. Pain was assessed using a visual analogue scale (0-100 mm) at 3, 6, 12 and 16 min. The instrument used for this was a blinded counter with one side reading 'no pain' to 'worst pain ever' with a numerical scale (0-100) on the reverse side. Pain scores were assessed looking at median and interquartile range and confidence intervals and calculating differences between treatment groups and analysing them using a paired t-test.

RESULTS

Thirteen patients received treatment to both fields. No significant difference in mean pain scores was seen with the use of Emla cream compared with placebo during treatment of scalp AKs (P = 0.328). There was no significant difference in requirement for oral analgesia following PDT between the two groups (P = 0.06).

CONCLUSIONS

Our data do not support the routine use of topical anaesthesia with Emla for topical PDT.

摘要

背景

光动力疗法（PDT）是治疗广泛头皮光化性角化病（AK）的一种有效治疗方式，但在使用5-氨基酮戊酸（ALA）作为敏化剂进行局部PDT治疗大面积病变时，疼痛是一个显著缺点。最近一项研究表明，使用丁卡因凝胶（Ametop）并不能显著减轻与PDT相关的疼痛。

目的

评估2.5%利多卡因与2.5%丙胺卡因的 eutetic 混合物（复方利多卡因乳膏）在局部ALA-PDT治疗头皮AK期间对疼痛的缓解作用。

方法

招募了14名年龄在59至83岁之间患有广泛头皮AK的男性，进行一项双盲安慰剂对照研究。定义了两个治疗区域（右和左额部头皮），并相隔2周进行治疗。这些区域随机接受复方利多卡因乳膏或水性乳膏作为第一次或第二次治疗。涂抹20%ALA乳膏4小时。涂抹局部麻醉剂或水性乳膏2小时。在3、6、12和16分钟时使用视觉模拟量表（0-100毫米）评估疼痛。用于此目的的仪器是一个盲法计数器，一侧标有“无疼痛”至“有史以来最严重的疼痛”，另一侧有数字量表（0-100）。通过查看中位数、四分位数间距和置信区间评估疼痛评分，并计算治疗组之间的差异，使用配对t检验进行分析。