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595纳米脉冲染料激光治疗病毒疣:与安慰剂对照的单盲随机比较研究

[595 nm pulse dye laser therapy for viral warts: a single-blind randomized comparative study versus placebo].

作者信息

Passeron T, Sebban K, Mantoux F, Fontas E, Lacour J-P, Ortonne J-P

机构信息

Service de Dermatologie, CHU de Nice.

出版信息

Ann Dermatol Venereol. 2007 Feb;134(2):135-9. doi: 10.1016/s0151-9638(07)91604-x.

Abstract

INTRODUCTION

Pulse dye laser (PDL) appears an attractive method to treat warts. However, data concerning the efficacy of this approach are based chiefly upon open clinical studies or case reports and results vary widely from one study to another. The purpose of this study was to compare the efficacy and safety of PDL with a placebo in the treatment of a homogeneous group of patients presenting palmoplantar warts.

METHODS

This was a randomized, prospective, placebo-controlled, single-blind study conducted between December 2004 and July 2005 in patients consulting for palmoplantar warts at the Dermatology Department of the University Teaching Hospital of Nice. The treatment settings used for the 595-nm PDL were as follows: spot diameter 5 mm, pulse duration 0.45 ms, fluence 9 J/cm2 with 5 passes at a frequency of 1 Hz. Cryogen spray cooling (system incorporated in the machine) was given at a rate of 50 spurts of 40 ms prior to each laser pulse. In patients in the placebo group, cooling pulses alone were given. For the plantar warts (in both groups), hyperkeratosis was removed manually with a scalpel before each session. A maximum of three sessions was administered at 3-week intervals. The type and number of warts was counted and recorded in a treatment schedule before the start of therapy, at each session and 5 weeks after the final session. The global safety of the treatment was evaluated using a visual analog scale between 0 (intolerable) and 10 (completely safe).

RESULTS

Nineteen patients were included in the laser group and 16 were included in the placebo group. Sixty-four per cent (48/75) of warts in the laser group resolved completely compared with 13% (4/30) in the placebo group (p<0.001). In the PDL group, 6 of 19 patients (31.5%) no longer had warts by the end of the study compared with 3 of 16 patients (18.75%) in the placebo group (p=0.46). The global safety score of the treatment as assessed by the patients themselves was 8.31 in the laser group and 9.81 in the placebo group.

DISCUSSION

Pulse dye laser appears to be an effective treatment in palmoplantar warts but the efficacy of this method seems to be only equivalent to that of standard treatments (cryotherapy or salicylic acid preparations). Safety is excellent and constitutes one of the major advantages of this technique. The absence of any proven superiority over the standard treatments in terms of efficacy, coupled with the high costs involved, means that PDL should only be used second-line therapy in patients wishing to avoid constraints affecting their professional activity.

摘要

引言

脉冲染料激光(PDL)似乎是一种治疗疣的有吸引力的方法。然而,关于这种方法疗效的数据主要基于开放性临床研究或病例报告,且不同研究结果差异很大。本研究的目的是比较PDL与安慰剂治疗一组患有掌跖疣患者的疗效和安全性。

方法

这是一项随机、前瞻性、安慰剂对照、单盲研究,于2004年12月至2005年7月在尼斯大学教学医院皮肤科对因掌跖疣前来咨询的患者中进行。用于595纳米PDL的治疗参数如下:光斑直径5毫米,脉冲持续时间0.45毫秒,能量密度9焦/平方厘米,以1赫兹频率照射5次。在每次激光脉冲前,以40毫秒的速率进行50次喷射的冷冻剂喷雾冷却(机器内置系统)。安慰剂组患者仅给予冷却脉冲。对于跖疣(两组均如此),每次治疗前用手术刀手动去除角化过度。每隔3周最多进行3次治疗。在治疗开始前、每次治疗时以及最后一次治疗后5周,在治疗记录中对疣的类型和数量进行计数和记录。使用0(无法忍受)至10(完全安全)的视觉模拟量表评估治疗的总体安全性。

结果

激光组纳入19例患者,安慰剂组纳入16例患者。激光组64%(48/75)的疣完全消退,而安慰剂组为13%(4/30)(p<0.001)。在PDL组中,19例患者中有6例(31.5%)在研究结束时不再有疣,而安慰剂组16例患者中有3例(18.75%)(p = 0.46)。患者自身评估的治疗总体安全评分为:激光组8.31,安慰剂组9.81。

讨论

脉冲染料激光似乎是治疗掌跖疣的有效方法,但这种方法的疗效似乎仅等同于标准治疗方法(冷冻疗法或水杨酸制剂)。安全性极佳,是该技术的主要优点之一。在疗效方面没有任何证据表明优于标准治疗方法,再加上成本高昂,这意味着PDL仅应作为希望避免影响其职业活动限制的患者的二线治疗方法。

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