Using 5-Aminolevulinic Acid and Pulsed Dye Laser for Photodynamic Treatment of Oral Leukoplakia
Using 5-Aminolevulinic Acid and Pulsed Dye Laser for Photodynamic Treatment of Oral Leukoplakia
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DOI：
10.1001/archoto.2011.178
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发表时间：
2011-11-01
影响因子：
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通讯作者：
Suen, James Y.
中科院分区：
文献类型：
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作者：
Shafirstein, Gal;Friedman, Adva;Suen, James Y.
目的：确定5-氨基乙酰丙酸和脉冲染料激光光动力疗法治疗口腔白斑的安全性和有效性。设计：非随机、单臂、单中心1/2期初步研究。设置：学术转诊中心。患者：共23例患者，年龄37至79岁，确诊白斑伴或不伴直径至少10 mm的异型增生。干预措施：应用5-氨基乙酰丙酸治疗损伤，然后用高功率585-nm脉冲染料激光激活。激光的最大耐受剂量、术后并发症、治疗的客观反应以及治疗组织的免疫组织化学变化。未发生显著不良事件;在研究的安全性阶段，在光动力治疗期间和之后观察到轻微的局部不良反应。最大耐受剂量为8 J/cm（2）。在17例患者中，7例（41%）消退超过75%（显著缓解），9例（53%）消退超过25%（部分缓解），90天时的总缓解率为94%。该应答率远高于该研究具有效力的零假设20%应答率（P < 10（-10））和替代假设50%应答率（P = .0001）。与基线水平相比，p53表达在11例有效样本中有8例（73%）升高，Ki-67表达在12例有效样本中有7例（58%）降低。结论：5-氨基乙酰丙酸联合脉冲染料激光光动力疗法可使口腔白斑消退。治疗是安全的，耐受性良好。在本研究中，发现1.5小时的应用时间和8 J/cm（2）的激光辐射暴露与1.5 ms的脉冲时间是最佳设置。本研究中使用的高功率激光可以在1至3分钟内完成激光治疗。进一步的研究是必要的，以确定最佳的激光辐射暴露和药物应用，以最大限度地提高响应率。
Objective: To determine the safety and efficacy of photodynamic therapy in the treatment of oral leukoplakia with 5-aminolevulinic acid and pulsed dye laser.Design: Nonrandomized, single-arm, single-site phase 1/2 pilot study.Setting: Academic referral center.Patients: A total of 23 patients, aged 37 to 79 years, having a confirmed diagnosis of leukoplakia with or without dysplasia measuring at least 10 mm in diameter.Interventions: Application of 5-aminolevulinic acid to lesions followed by activation with high-power 585-nm pulsed dye laser.Main Outcome Measures: Maximum tolerated dose of laser, postprocedure complications, objective response to treatment, and immunohistochemical changes in treated tissue.Results: No significant adverse events occurred; minor local adverse effects were observed during and following photodynamic therapy in the safety phase of the study. The maximum tolerated dose was 8 J/cm(2). Of 17 patients, 7 (41%) had more than 75% regression (significant response) and 9 (53%) had more than 25% regression (partial response), for an overall response rate of 94% at 90 days. This response rate was far higher than the null-hypothesis 20% rate (P < 10(-10)) and the alternative-hypothesis 50% rate (P = .0001) for which the study was powered. When compared with baseline levels immunohistochemically, p53 expression was increased in 8 of 11 available samples (73%) and Ki-67 expression was decreased in 7 of 12 available samples (58%).Conclusions: Photodynamic therapy with 5-aminolevulinic acid and pulsed dye laser could be used to achieve regression of oral leukoplakia. The treatment is safe and well tolerated. An application time of 1.5 hours and laser radiant exposure of 8 J/cm(2) with 1.5-ms pulse time were found to be the optimal settings in this study. The high-power laser used in this study allows completion of laser therapy within 1 to 3 minutes. Further studies are necessary to determine the optimal laser radiant exposure and drug application to maximize the response rate.