两项随机、双盲、安慰剂对照研究，评估S-Caine Peel在长脉冲Nd:YAG激光治疗腿部静脉前诱导局部麻醉的效果。

Two randomized, double-blind, placebo-controlled studies evaluating the S-Caine Peel for induction of local anesthesia before long-pulsed Nd:YAG laser therapy for leg veins.

作者信息

Chen John Z S, Alexiades-Armenakas Macrene R, Bernstein Leonard J, Jacobson Laurie G, Friedman Paul M, Geronemus Roy G

机构信息

Laser and Skin Surgery Center of New York, New York 10016, USA.

出版信息

Dermatol Surg. 2003 Oct;29(10):1012-8. doi: 10.1046/j.1524-4725.2003.29293.x.

DOI:10.1046/j.1524-4725.2003.29293.x

PMID:12974697

Abstract

BACKGROUND

Topical anesthetics are valuable tools for many dermatologic procedures.

OBJECTIVE

To evaluate the efficacy and safety of S-Caine Peel composed of 1:1 (wt:wt) mixture of 7% lidocaine and 7% tetracaine in the induction of local anesthesia before long-pulsed Nd:YAG laser therapy for leg veins.

METHODS

Two randomized, double-blinded, placebo-controlled trials were performed. In study 1, 60 adults received S-Caine Peel and placebo cream for 30 or 60 minutes. Efficacy was evaluated by a patient visual analog scale and impression. The pain scale and impression were evaluated by the investigator and an independent observer. In study 2, 40 adults received 60- and 90-minute applications.

RESULTS

In study 1, the 30- and 60-minute application times were grouped: Patients had adequate pain relief in 48% of S-Caine sites versus 23% of placebo sites (P<0.001). Investigators reported none-to-mild pain in 50% of active sites versus 33% of placebo sites (P=0.007), with adequate anesthesia in 65% of active sites versus 43% of placebo sites (P=0.002). The independent witness assessed none-to-mild pain in 52% of active sites versus 37% of placebo sites (P=0.067). In study 2, investigators rated none-to-mild pain in 75% of 60-minute and 85% of 90-minute S-Caine sites versus 30% and 50% of placebo sites (P=0.012 and P=0.002, respectively), with adequate anesthesia in 70% and 85% of 60- and 90-minute of active sites versus 25% and 20% of placebo sites (P=0.029 and P=0.001, respectively). The independent witness rated none to mild pain in 80% and 85% of 60 and 90 minute of S-Caine sites versus 35% and 50% of placebo sites (P=0.008 and P=0.004).

CONCLUSION

The S-Caine Peel provides safe and highly effective local anesthesia when applied for at least 60 minutes for laser therapy of leg veins. Facile removal of the peel provides a unique advantage and ease in administration.

摘要

背景

局部麻醉剂是许多皮肤科手术中很有价值的工具。

目的

评估由7%利多卡因和7%丁卡因按1:1（重量比）混合组成的S-Caine Peel在长脉冲Nd:YAG激光治疗腿部静脉前诱导局部麻醉的有效性和安全性。

方法

进行了两项随机、双盲、安慰剂对照试验。在研究1中，60名成年人接受S-Caine Peel和安慰剂乳膏涂抹30或60分钟。通过患者视觉模拟量表和印象评估疗效。疼痛量表和印象由研究者和独立观察者评估。在研究2中，40名成年人接受60分钟和90分钟的涂抹。

结果

在研究1中，将30分钟和60分钟的涂抹时间分组：S-Caine涂抹部位有48%的患者疼痛得到充分缓解，而安慰剂部位为23%（P<0.001）。研究者报告活性部位50%无至轻度疼痛，安慰剂部位为33%（P=0.007），活性部位65%有充分麻醉，安慰剂部位为43%（P=0.002）。独立观察者评估活性部位52%无至轻度疼痛，安慰剂部位为37%（P=0.067）。在研究2中，研究者对60分钟S-Caine涂抹部位的75%和90分钟S-Caine涂抹部位的85%评定为无至轻度疼痛，而安慰剂部位分别为30%和50%（P分别为0.012和0.002），60分钟和90分钟活性部位分别有70%和85%有充分麻醉，安慰剂部位分别为25%和20%（P分别为0.029和0.001）。独立观察者对60分钟和90分钟S-Caine涂抹部位的80%和85%评定为无至轻度疼痛，而安慰剂部位分别为35%和50%（P分别为0.008和0.004）。