口腔疾病防治 ›› 2022, Vol. 30 ›› Issue (5): 330-337.DOI: 10.12016/j.issn.2096-1456.2022.05.004

• 临床研究 • 上一篇    下一篇

用德尔菲法确定5-氨基酮戊酸光动力疗法治疗口腔潜在恶性疾患专家共识的临床问题及结局指标

刘子建(), 王兴, 韩莹, 刘宏伟()   

  1. 北京大学口腔医学院·口腔医院口腔黏膜科,国家口腔医学中心 国家口腔疾病临床医学研究中心 口腔数字化医疗技术和材料国家工程实验室,北京(100081)
  • 收稿日期:2021-10-15 修回日期:2021-11-26 出版日期:2022-05-20 发布日期:2022-02-17
  • 通讯作者: 刘宏伟
  • 作者简介:刘子建,住院医师,博士,Email: pkuliuzj@pku.edu.cn
  • 基金资助:
    国家自然科学基金项目(81771071);国家自然科学基金项目(U19A2005)

Clinical problems and outcome indicators in the expert consensus determined by the Delphi method of 5-aminolevulinic acid photodynamic therapy for the treatment of oral potential malignant diseases

LIU Zijian(), WANG Xing, HAN Ying, LIU Hongwei()   

  1. Department of Oral Mucosa, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing 100081, China
  • Received:2021-10-15 Revised:2021-11-26 Online:2022-05-20 Published:2022-02-17
  • Contact: LIU Hongwei
  • Supported by:
    National Natural Science Foundation of China(81771071);National Natural Science Foundation of China(U19A2005)

摘要:

目的 确定需要纳入5-氨基酮戊酸(5-aminolevulinic acid,ALA)光动力疗法治疗口腔潜在恶性疾患专家共识的临床问题与结局指标。方法 在查阅相关文献的基础上,通过会议形成了临床问题与结局指标初稿,应用德尔菲法进行专家咨询,收集专家意见,并计算投票结果的平均值、标准差确定指标的重要程度,计算积极系数、变异系数、协调系数等进行质量控制。结果 第一轮德尔菲法根据参考文献及专家讨论共纳入8个临床问题(光动力照射剂量主要参考要素、具体参数、光源选择、疗效的评价标准、不良反应的预防方案、给药浓度、对角化增厚的病损是否需要预处理和给药方式)的12个结局指标(主要参考要素包括光子积分通量、功率密度、照光时间和光斑直径;具体参数为光子积分通量为100 J/cm2,功率密度为100~600 mW/cm2、光源选择(630 ± 5)nm波长的二极管激光器;以病损大小变化作为评价标准;以局部麻醉为主,辅以低温及间歇性激光照射的方法作为治疗前的镇痛方案;对角化增厚的病损需要预处理;ALA的给药浓度定为20%)。第二轮共89位专家填写问卷,对6个临床问题(光动力照射剂量主要参考要素、具体参数、光源选择、疗效的评价标准、给药浓度和给药方式)的9个结局指标(主要参考要素包括光子积分通量、功率密度、照光时间;具体参数为光子积分通量为100 J/cm 2,功率密度为100~600 mW/cm2;光源选择(630 ± 5)nm波长的二极管激光器;以病损大小变化作为评价标准;光敏剂ALA给药浓度定为20%),均给予非常重要的评定,其余3个予重要的评定,一致性较好。结论 本研究通过德尔菲法确定ALA光动力疗法治疗口腔潜在恶性疾患的照射剂量、给药方式及浓度、疗效的评价标准、不良反应的预防及预处理方案,专家意见具有较好的一致性,达成共识。

关键词: 德尔菲法, 5-氨基酮戊酸光动力疗法, 活性氧, 自由基, 口腔潜在恶性疾患, 照射剂量, 疗效评价, 不良反应

Abstract:

Objective To determine the clinical problems and outcome indicators that need to be included in the expert consensus of 5-aminolevulinic acid (ALA) photodynamic therapy in the treatment of oral potential malignant diseases. Methods Based on the relevant literature, the clinical problems and outcome indicators were drafted during the meeting. The Delphi method was used for expert consultation and expert opinion collection. The average and standard deviation of the voting results were calculated to determine the importance of the indicators, and the positive coefficient, variation coefficient and coordination coefficient were calculated for quality control. Results In the first round of the Delphi method, 12 outcome indicators (the main reference elements include photon integral flux, power density, illumination time, and spot diameter were identified; the specific parameters are photon integral flux of 100 J/cm2 and power density of 100-600 mW/cm2. A diode laser of (630 ± 5) nm wavelength should be chosen. The analgesic regimen is local anesthesia supplemented by hypothermia and intermittent laser irradiation before treatment. Lesions with hyperkeratotic require pretreatment. The concentration of ALA administered was set at 20%. Eight clinical problems (main reference elements of photodynamic irradiation dose, specific parameters, choice of light source, evaluation criteria of efficacy, prevention of adverse effects, dosing concentration, whether oral potentially malignant diseases with hyperkeratosis should be pretreated, administration of photosensitizers) were included according to the literature and expert discussion. In the second round, 89 experts completed the questionnaire and gave very important evaluations of 9 outcome indicators (the main reference elements included photon integral flux, power density and illumination time; the specific parameters were a photon integral flux of 100 J/cm 2 and a power density of 100-600 mW/cm2). A diode laser of (630 ± 5)nm wavelength should be chosen. The concentration of ALA administered was set at 20%. Six clinical problems (main reference elements of photodynamic irradiation dose, specific parameters, choice of light source, evaluation criteria of efficacy, dosing concentration, administration of photosensitizers), and the remaining 3 were given important evaluations, with good consistency. Conclusion In this study, the irradiation dose, mode of administration and concentration, evaluation criteria of efficacy, prevention of adverse effects and pretreatment regimen of ALA photodynamic therapy for oral potentially malignant diseases determined by the Delphi method had good agreement among experts.

Key words: Delphi method, 5-aminolevulinic acid photodynamic therapy, active oxygen, free radicals, potential malignant oral diseases, irradiation dose, efficacy evaluation, adverse reactions

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