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比较利多卡因/ 丁卡因乳膏和利多卡因/ 布比卡因乳膏在激光治疗头部瘢痕性脱发和纹身去除术中的局部麻醉效果:两项随机对照试验的结果。

Comparison of lidocaine/tetracaine cream and lidocaine/prilocaine cream for local anaesthesia during laser treatment of acne keloidalis nuchae and tattoo removal: results of two randomized controlled trials.

机构信息

Department of Dermatology, Erasmus MC University Medical Centre Rotterdam, Rotterdam, the Netherlands.

出版信息

Br J Dermatol. 2017 Jan;176(1):81-86. doi: 10.1111/bjd.14848. Epub 2016 Dec 10.

Abstract

BACKGROUND

Pain is a common adverse effect of dermatological laser procedures. Currently, no standard topical anaesthetic cream exists for deeper dermal laser procedures.

OBJECTIVES

To compare the efficacy of lidocaine/tetracaine cream and lidocaine/prilocaine cream in reducing self-reported pain during deeper dermal laser treatment of acne keloidalis nuchae (AKN) and tattoos.

METHODS

We conducted two randomized, double-blind, controlled clinical trials with intrapatient, split-lesion designs: study A included patients with AKN (n = 15); study B included patients with black tattoos (n = 15). The primary end point was the patients' self-reported pain on a 10-cm visual analogue scale (VAS). Secondary objectives were the percentage of patients with adequate pain relief, willingness to pay €25 for the cream that provided the best pain relief and safety of the creams.

RESULTS

In both studies, VAS scores were lower for lidocaine/prilocaine cream, with a mean VAS difference in study A of 1·9 [95% confidence interval (CI) 1·0-2·8] and in study B of 0·6 (95% CI -0·7 to 1·9). In study A, adequate pain relief was achieved in 13% (n = 2) with lidocaine/tetracaine cream vs. 73% (n = 11) with lidocaine/prilocaine cream (P = 0·004), and in study B in 53% (n = 8) vs. 80% (n = 12), respectively (P = 0·289). In study A, 47% (n = 7) were willing to pay an additional €25 vs. 73% (n = 11) in study B. No serious adverse events occurred.

CONCLUSIONS

Lidocaine/prilocaine cream under plastic occlusion is the preferred topical anaesthetic during painful laser procedures targeting dermal chromophores.

摘要

背景

疼痛是皮肤科激光治疗的常见不良反应。目前,对于较深层的真皮激光治疗,还没有标准的局部麻醉乳膏。

目的

比较利多卡因/丁卡因乳膏和利多卡因/丙胺卡因乳膏在减轻脱发性瘢痕性毛囊炎(AKN)和纹身患者接受较深层真皮激光治疗时自我报告疼痛的效果。

方法

我们进行了两项随机、双盲、对照临床试验,采用患者自身对照、皮损内对照设计:研究 A 纳入 AKN 患者(n=15);研究 B 纳入黑色纹身患者(n=15)。主要终点是患者在 10cm 视觉模拟量表(VAS)上的自我报告疼痛。次要目标是评估有足够疼痛缓解的患者比例、愿意为提供最佳疼痛缓解的乳膏支付 25 欧元的患者比例,以及乳膏的安全性。

结果

在两项研究中,利多卡因/丙胺卡因乳膏的 VAS 评分均较低,研究 A 的平均 VAS 差值为 1.9(95%置信区间[CI] 1.0-2.8),研究 B 的平均 VAS 差值为 0.6(95% CI -0.7 至 1.9)。在研究 A 中,利多卡因/丁卡因乳膏组有 13%(n=2)的患者获得足够的疼痛缓解,而利多卡因/丙胺卡因乳膏组有 73%(n=11)的患者获得足够的疼痛缓解(P=0.004);在研究 B 中,利多卡因/丁卡因乳膏组有 53%(n=8)的患者获得足够的疼痛缓解,而利多卡因/丙胺卡因乳膏组有 80%(n=12)的患者获得足够的疼痛缓解(P=0.289)。在研究 A 中,47%(n=7)的患者愿意额外支付 25 欧元,而在研究 B 中,73%(n=11)的患者愿意额外支付 25 欧元。未发生严重不良事件。

结论

利多卡因/丙胺卡因乳膏加用塑料膜封闭是针对真皮色素的疼痛性激光治疗的首选局部麻醉乳膏。

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