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消融性微剥脱激光辅助光动力疗法与消融性微剥脱激光治疗口腔白斑病的随机对照初步研究。

Ablative fractional laser-assisted photodynamic therapy vs. ablative fractional laser for oral leukoplakia treatment: A randomized, controlled pilot study.

机构信息

Department of Oral Mucosal disease, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China; National Clinical Research Center for Oral Diseases, Shanghai 200011, China; Shanghai Key Laboratory of Stomatology, Shanghai 200011, China.

Department of Oral Mucosal disease, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China; College of Stomatology, Shanghai Jiao Tong University, Shanghai 200011, China; National Center for Stomatology, Shanghai 200011, China.

出版信息

Photodiagnosis Photodyn Ther. 2021 Dec;36:102523. doi: 10.1016/j.pdpdt.2021.102523. Epub 2021 Sep 4.

DOI:10.1016/j.pdpdt.2021.102523
PMID:34487871
Abstract

BACKGROUND

Ablative fractional laser-assisted photodynamic therapy (AFL-PDT) is explored as an effective method in some premalignant diseases, whereas the effect of AFL-PDT on oral leukoplakia (OL), the best-known precursor of oral squamous cell carcinoma, remains undetermined.

METHODS

Forty-eight patients, histologically diagnosed with OL, were randomized (1:1) to receive either AFL-PDT or ablative fractional laser (AFL) treatment. All patients were followed up at 1, 3, 6 and 12 months postoperatively. The primary endpoints of efficacy and clinical recurrence and the secondary endpoint of side effects were assessed.

RESULTS

Forty-four patients completed the study. The 100% effective cure rate in the AFL-PDT group was higher than that in AFL group (80.9%, P<0.05) with 19.1% difference (95%CI: 0.7-40.0%). Compared to AFL group, recurrence observed at 6 and 12 months post-treatment tended to occur in fewer patients in the AFL-PDT group (P<0.05). No severe adverse events or systemic side effects were observed in either group.

CONCLUSIONS

AFL-PDT may effectively reduce recurrence of OL with high clinical efficacy and good tolerability, suggesting it may be a promising treatment for OL.

摘要

背景

光消融术辅助光动力疗法(AFL-PDT)在某些癌前病变中被探索为一种有效方法,而光消融术对口腔白斑病(OL)的疗效,OL 是口腔鳞状细胞癌最著名的前体,仍不确定。

方法

48 例经组织学诊断为 OL 的患者被随机(1:1)分为 AFL-PDT 或光消融术(AFL)治疗组。所有患者均在术后 1、3、6 和 12 个月进行随访。评估疗效和临床复发的主要终点以及不良反应的次要终点。

结果

44 例患者完成了研究。AFL-PDT 组的 100%有效治愈率高于 AFL 组(80.9%,P<0.05),差异为 19.1%(95%CI:0.7-40.0%)。与 AFL 组相比,AFL-PDT 组在治疗后 6 个月和 12 个月观察到的复发患者人数较少(P<0.05)。两组均未观察到严重不良事件或全身不良反应。

结论

AFL-PDT 可能有效降低 OL 的复发率,具有较高的临床疗效和良好的耐受性,表明其可能是 OL 的一种有前途的治疗方法。

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