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北京大学学报（医学版） ›› 2025, Vol. 57 ›› Issue (1): 91-96. doi: 10.19723/j.issn.1671-167X.2025.01.014

• 论著 • 上一篇    下一篇

细针扣刺预处理联合光动力疗法治疗口腔白斑

韩莹, 赵璞, 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，口腔生物材料和数字诊疗装备国家工程研究中心，国家药品监督管理局口腔材料重点实验室，北京 100081
  • 收稿日期:2024-09-30 出版日期:2025-02-18 发布日期:2025-01-25
  • 通讯作者: 刘宏伟 E-mail:hongweil@126.com
  • 基金资助:
    北京大学口腔医院临床研究专项(PKUSS-2023CRF304);北京大学口腔医院临床新技术新疗法项目(PKUSSNCT-21A13)

Microneedle combined with photodynamic therapy in the treatment of oral leukoplakia

Ying HAN, Pu ZHAO, Hongwei LIU*()   

  1. Department of Oral Medicine, Peking University School and Hospital of Stomatology & National Center for Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Research Center of Oral Biomaterials and Digital Medical Devices & NMPA Key Laboratory for Dental Materials, Beijing 100081, China
  • Received:2024-09-30 Online:2025-02-18 Published:2025-01-25
  • Contact: Hongwei LIU E-mail:hongweil@126.com
  • Supported by:
    Clinical Research Foundation of Peking University School and Hospital of Stomatology(PKUSS-2023CRF304);Program for New Clinical Techniques and Therapies of Peking University School and Hospital of Stomatology(PKUSSNCT-21A13)

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摘要：

目的: 探索进行细针扣刺预处理是否能显著提高常规5-氨基酮戊酸(5-aminolevulinic acid，ALA)-光动力疗法(photodynamic therapy，PDT)治疗口腔白斑的效率及其安全性。方法: 采用非随机对照临床试验方法，收集就诊于北京大学口腔医院口腔黏膜科，临床及病理均诊断为口腔白斑的患者，将患者分为试验组和对照组。对照组采用传统的ALA-PDT治疗，试验组先在利多卡因表面麻醉下进行细针扣刺预处理，再接受常规ALA-PDT治疗。记录两组患者的临床分型，测量病损面积，评价临床疗效，分析单位面积病损治疗时间和治疗次数等，并通过视觉模拟评分法对患者治疗后的疼痛情况进行评价, 对两组的上述数据进行统计学分析。结果: 试验组共纳入患者11例，对照组共纳入患者19例。试验组与对照组的病损完全缓解率分别为45.5%和36.8%，部分缓解率分别为54.5%和57.9%，无缓解率分别为0%和5%；总有效率(包括完全缓解及部分缓解)分别为100%和95%，两组间差异无统计学意义(Z=-1.031，P=0.456)。试验组和对照组单位面积病损平均治疗时间分别为(9.05±5.74) min/cm2和(21.38±15.44) min/cm2，平均治疗次数分别为(2.36±0.67)次和(3.58±1.57)次，两组间差异均有统计学意义(t=-3.125，P < 0.05；t=-2.932，P < 0.05)。进一步的多元线性回归分析也再次证实预处理能够显著缩短治疗时间(P < 0.05)。此外，两组患者治疗后疼痛评分(视觉模拟评分法)差异无统计学意义，细针扣刺预处理并没有增加ALA-PDT治疗的不良反应。结论: 细针扣刺预处理后行常规ALA-PDT对于口腔白斑显示出良好的临床疗效，可以显著缩短临床治疗时间，减少患者就诊次数，节约医疗成本。

关键词: 口腔白斑, 光动力治疗, 细针扣刺预处理

Abstract:

Objective: To explore whether microneedle pretreatment can significantly improve the efficacy and safety of 5-aminolevulinic acid (ALA)-photodynamic therapy (PDT) in the treatment of oral leukoplakia. Methods: A non-randomized controlled clinical trial was conducted. Patients with clinical and pathological diagnosis of oral leukoplakia in the Department of Oral Mucosa, Peking University School and Hospital of Stomatology were divided into experimental group and control group. The control group was treated with conventional ALA-PDT, and the experimental group was pretreated with micro- needle buckling under superficial anesthesia with lidocaine before conventional ALA-PDT. The clinical manifestations of the two groups were recorded, the lesion area was measured, the clinical efficacy was evaluated, the number of treatment sessions and treatment unit duration were analyzed, and the pain after treatment was evaluated by visual analogue scale. The above data of the two groups were statistically analyzed. Results: A total of 11 patients were included in the experimental group and 19 patients were included in the control group. The complete remission rate of the experimental group and the control group was 45.5% and 36.8%, the partial remission rate was 54.5% and 57.9%, and the no remission rate was 0% and 5%, respectively. There was no significant difference in the treatment effect between the two groups. Meanwhile, the treatment unit duration of the experimental group and the control group were (9.05±5.74) min/cm2 and (21.38±15.44) min/cm2, respectively, and the number of treatment sessions were (2.36±0.67) times and (3.58±1.57) times, respectively. These differences between the two groups were statistically significant (t=-3.125, P < 0.05; t=-2.932, P < 0.05). Similarly, multiple linear regression analysis with 7 factors including age, dysplastic pathology, lesion classification, etc., also confirmed that pretreatment could significantly shorten the treatment unit duration (P < 0.05). In addition, there was no significant difference in pain score (visual analogue scale) between the two groups after treatment, and the microneedle puncture pretreatment did not increase the adverse reactions of ALA-PDT treatment. Conclusion: Microneedle pretreatment followed by conventional ALA-PDT shows a good clinical effect on oral leukoplakia, which can significantly shorten the clinical treatment time, reduce the number of visits, and save medical costs.

Key words: Oral leukoplakia, Photodynamic therapy, Microneedle pretreatment

中图分类号: 

  • R781.5

图1

进行激光照射  图 2  敷用ALA之前的预处理(A为使用细针扣刺，B为完成扣刺后局部见红)"

表1

试验组和对照组口腔白斑患者人口学资料、临床和病理分型"

ItemsExperimental group (n=11)Control group (n=19)
Age/years, ${\bar x}$±s57.36±15.3756.37±12.20
Sex, n(%)
  Male10 (90.9)7 (36.8)
  Female1 (9.1)12 (63.2)
Oral leukoplakia history/month, ${\bar x}$±s42.47±52.583±22.10
Smoke history, n(%)
  Yes3 (27.3)2 (10.5)
  No8 (72.7)17 (89.5)
Total lesion area/cm2, ${\bar x}$±s5.21±4.602.65±2.35
Lesions location, n(%)
  Keratinized1 (9.1)44(21.1)
  Non-keratinized10 (90.9)15(78.9)
Lesion classification, n(%)
  Non-homogenous6 (54.5)15 (78.9)
  Homogenous5 (45.5)4 (21.1)
Dysplastic pathology, n(%)
  Non-dysplastic3 (27.3)4 (21.1)
  Mildly dysplastic2 (18.2)5 (26.3)
  Moderately to severely dysplastic6 (54.5)10 (52.6)

表2

试验组和对照组ALA-PDT的临床疗效"

ItemExperimental group (n=11)Control group (n=19)StatisticsP
Response to ALA-PDT, n(%)Z=-1.0310.456
  Complete remission and partial remission11 (100)18 (95)
  No remission01 (5)
Treatment unit duration (min/cm2), ${\bar x}$±s9.06±5.7421.38±15.44t=-3.125< 0.05
Number of treatment sessions, ${\bar x}$±s2.36±0.673.58±1.57t=-2.932< 0.05

图3

试验组口腔白斑患者治疗前后病损变化情况"

表3

不同病理分型口腔白斑的单位面积病损治疗时间"

Dysplastic pathologyTreatment unit duration/(min/cm2)
Experimental group (n=11)Control group (n=19)
Non-dysplastic4.68±2.8922.51±18.55
Mildly dysplastic6.37±4.3815.05±4.93
Moderately to severely dysplastic12.14±5.7324.09±16.65

表4

口腔白斑单位面积病损ALA-PDT治疗时间的多元线性回归分析"

Independent variablesBSEβtP
Constant4.91426.5620.1850.855
Age-0.0250.206-0.024-0.1220.904
Oral leukoplakia history0.0020.0590.0070.0330.974
Pretreatment13.0995.9430.0462.2040.038
Smoking55.2397.453-0.142-0.7030.489
Dysplastic pathology2.8023.5830.1680.7820.443
Lesions location-4.5777.683-0.124-0.5960.557
lesion classification2.6656.1840.0890.4310.671
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ISSN 1671-167X
CN 11-4691/R
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