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削除术联合强脉冲光与单纯削除术治疗顽固性手足疣:一项结局评估设盲的随机临床试验

Paring and intense pulsed light versus paring alone for recalcitrant hand and foot warts: a randomized clinical trial with blinded outcome evaluation.

作者信息

Togsverd-Bo Katrine, Gluud Christian, Winkel Per, Larsen Helle K, Lomholt Hans B, Cramers Marie, Bjerring Peter, Haedersdal Merete

机构信息

Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Bispebjerg Bakke 23, 2400 Copenhagen, Denmark.

出版信息

Lasers Surg Med. 2010 Feb;42(2):179-84. doi: 10.1002/lsm.20852.

DOI:10.1002/lsm.20852
PMID:20166158
Abstract

BACKGROUND AND OBJECTIVES

Treatment of recalcitrant viral warts remains a therapeutic challenge. Intense pulsed light (IPL) has been suggested effective to clear wart tissue. The objective was in a randomized controlled trial to assess the efficacy of paring followed by IPL versus paring alone for recalcitrant hand and foot warts.

MATERIALS AND METHODS

Eighty-nine patients with recalcitrant hand and foot warts were included and randomized (1:1) to three treatments at 3-week intervals with either paring of warts followed by IPL or paring of warts alone. IPL was given with the Ellipse Flex IPL system (Danish Dermatologic Development A/S, Hørsholm, Denmark, 400-950 nm, 5.5 millisecond pulse duration in double pulses with a 2 millisecond interval, 26.0-32.5 J/cm(2) repetitive passes). The primary outcome was complete and partial clearance of warts evaluated by blinded photo assessment at 6 weeks after final treatment. Secondary outcomes were treatment related pain and adverse reactions.

RESULTS

We found no significant difference in clearance of warts between the two intervention groups (OR 1.64, 95% confidence interval 0.62-4.38). Paring followed by IPL resulted in complete or partial clearance of wart tissue in nine (22%) and five patients (12.2%) versus five (13.5%) and four patients (10.8%) from paring alone. Mostly plantar warts were treated (92.1%). The pain intensity after paring and IPL was moderate and significantly higher than the pain intensity after paring alone (P<0.0005). No adverse reactions were observed from the two interventions.

CONCLUSION

Paring followed by IPL did not differ significantly from paring alone in clearance of recalcitrant hand and foot warts but caused significantly more pain.

摘要

背景与目的

顽固性病毒疣的治疗仍是一项治疗挑战。已有研究表明强脉冲光(IPL)对清除疣体组织有效。本研究的目的是通过一项随机对照试验,评估疣体削除联合IPL与单纯疣体削除治疗顽固性手足疣的疗效。

材料与方法

纳入89例顽固性手足疣患者,随机(1:1)分为两组,每组间隔3周接受3次治疗,一组先进行疣体削除,随后接受IPL治疗,另一组仅进行疣体削除。IPL治疗采用Ellipse Flex IPL系统(丹麦皮肤病学发展有限公司,丹麦霍斯霍尔姆,波长400 - 950 nm,双脉冲模式,脉冲持续时间5.5毫秒,间隔2毫秒,重复照射剂量26.0 - 32.5 J/cm²)。主要结局指标为末次治疗后6周通过盲法照片评估疣体的完全清除和部分清除情况。次要结局指标为治疗相关疼痛和不良反应。

结果

我们发现两组干预措施在疣体清除率上无显著差异(比值比1.64,95%置信区间0.62 - 4.38)。疣体削除联合IPL治疗后,疣体组织完全或部分清除的患者有9例(22%)和5例(12.2%),而单纯疣体削除组分别为5例(13.5%)和4例(10.8%)。大部分为跖疣(92.1%)。疣体削除联合IPL治疗后的疼痛强度为中度,且显著高于单纯疣体削除后的疼痛强度(P < 0.0005)。两种干预措施均未观察到不良反应。

结论

疣体削除联合IPL与单纯疣体削除在顽固性手足疣的清除效果上无显著差异,但前者引起的疼痛明显更剧烈。

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