Pilot Study Examining the Combined Use of Pulsed Dye Laser and Topical Imiquimod Versus Laser Alone for Treatment of Port Wine Stain Birthmarks
Pilot Study Examining the Combined Use of Pulsed Dye Laser and Topical Imiquimod Versus Laser Alone for Treatment of Port Wine Stain Birthmarks
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DOI：
10.1002/lsm.20716
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发表时间：
2008-11-01
影响因子：
2.4
通讯作者：
Nelson, J. Stuart
中科院分区：
文献类型：
--
作者：
Chang, Cheng-Jen;Hsiao, Yen-Chang;Nelson, J. Stuart
背景与目的：本研究的目的是改善葡萄酒染色（PWS）在激光治疗后的治疗效果。我们的具体目的是确定脉冲染料激光（PDL）治疗和局部咪喹莫特联合使用与单独使用PDL是否可以改善PWS的治疗结果。研究设计/材料和方法：本初步研究纳入20名PWS患者，均为亚洲人。受试者年龄在3至56岁之间。入组后，在每个受试者上前瞻性地确定三个试验点，以分配以下治疗方案：(A) PDL+咪喹莫特；(B)单独PDL；(C)单独使用咪喹莫特。PDL试验点接受585 nm波长的单次处理；脉冲持续时间1.5毫秒；光斑大小为7mm，使用10j /cm(2)的轻剂量，并使用冷冻剂喷雾冷却。对于PE)L+咪喹莫特和咪喹莫特单独试验点，受试者被指示在PDL暴露后1个月内每天局部使用咪喹莫特一次。受试者在PDL暴露后1、3、6和12个月进行随访，以评估三个测试点。主要的疗效测量是定量评估白化反应，通过皮肤光谱仪测量，计算PDL暴露后1、3、6和12个月每个部位的血红蛋白指数。受试者也被密切监测是否有任何不良反应。结果：基于配对样本检验分析，与单独使用PDL或咪喹莫特相比，PWS接受PDL+咪喹莫特治疗的患者的漂白反应随时间的变化具有临床统计学意义（P < 0.05）。在12个月时，应该注意的是，有一些证据表明PDL+咪喹莫特和单独PDL治疗PWS试验部位再变暗，可能是由于血管血运重建。然而，根据PDL暴露后1个月和12个月测定的血红蛋白指数的比较，与单独PDL相比，PI)L+咪喹莫特治疗的PWS试验点血运重建较少（P < 0.05）。在PDL+咪喹莫特和PDL单独试验点，分别有10% （n = 2）和40% （n = 8）的受试者出现短暂性色素沉着。所有部位的色素沉着均在6个月内自行消退，无需医疗干预。在任何测试部位均未观察到永久性色素沉着或瘢痕形成。结论：根据这项初步研究的结果，随着时间的推移，与单独使用PDL相比，PDL+咪喹莫特对PWS病变试验点的治疗效果更好。虽然PDL+咪喹莫特方法很有趣，但需要在大量PWS患者样本中进行临床验证。激光外科杂志，2008。(c) 2008 Wiley-Liss, Inc。
Background and Objective: The objective of this study was to improve port wine stain (PWS) therapeutic outcome in response to laser therapy. Our specific aim was to determine whether the combined use of pulsed dye laser (PDL) therapy and topical Imiquimod versus PDL alone can improve PWS therapeutic outcome.Study Design/Materials and Methods: This pilot study involved a retrospective review of 20 subjects, all Asian, with PWS. Subject ages ranged between 3 and 56 years. Upon enrollment, three test sites were prospectively identified on each subject for treatment assignments to the following regimens: (A) PDL+Imiquimod; (B) PDL alone; and (C) Imiquimod alone. PDL test sites received a single treatment with a 585 nm wavelength; 1.5 milliseconds pulse duration; spot size 7 mm using a light dosage of 10 J/cm(2) with cryogen spray cooling. For the PE)L+Imiquimod and Imiquimod alone test sites, subjects were instructed to apply Imiquimod topically to the sites once daily for 1 month after PDL exposure. Subjects were followed-up at 1, 3, 6, and 12 months after PDL exposure to evaluate each of the three test sites. The primary efficacy measurement was the quantitative assessment of blanching responses as measured by a DermoSpectrometer to calculate the hemoglobin-index of each site at 1, 3, 6, and 12 months after PDL exposure. Subjects were also closely monitored for any adverse effects.Results: Based on paired sample test analysis, there were clinically, and statistically significant, differences in blanching responses over time favoring PWS receiving PDL+Imiquimod as compared to either PDL or Imiquimod alone (P < 0.05). At 12 months, it should be noted that there was some evidence of redarkening of PWS test sites treated by PDL+Imiquimod and PDL alone, presumably due to revascularization of blood vessels. However, based on comparison of the hemoglobin-indices determined at 1 and 12 months after PDL exposure, there was less revascularization of PWS test sites treated with PI)L+Imiquimod as compared to PDL alone (P < 0.05). Transient hyperpigmentation was noted in 10% (n = 2) and 40% (n = 8) of subjects on the PDL+Imiquimod and PDL alone test sites, respectively. On all sites, hyperpigmentation resolved spontaneously without medical intervention within 6 months. Permanent hypopigmentation or scarring was not observed on any test site.Conclusion: Based on the results of this pilot study, PDL+Imiquimod resulted in superior blanching responses over time as compared to PDL alone for treatment of test sites on PWS lesions. Although the PDL+Imiquimod approach is intriguing, clinical validation in large PWS patient samples is required. Lasers Surg. Med. 40:605610, 2008. (c) 2008 Wiley-Liss, Inc.