国际口腔医学杂志

国际口腔医学杂志 ›› 2022, Vol. 49 ›› Issue (6): 633-640.doi: 10.7518/gjkq.2022099

• 论著 • 上一篇    下一篇

口服β-胡萝卜素治疗非糜烂型口腔扁平苔藓的随机对照试验研究

张沈懿1(),王翔剑1,2,石黎冉1,石佳鸿1,汪玉红1,3(),周红梅1   

  1. 1.口腔疾病研究国家重点实验室;国家口腔医学中心 国家口腔疾病临床医学研究中心;口腔医学+前沿医学创新中心 四川大学华西口腔医院口腔黏膜病科 成都 610041
    2.浙江大学医学院附属第二医院口腔内科 杭州 310009
    3.空军军医大学口腔医院口腔黏膜病科 西安 710032
  • 收稿日期:2022-02-05 修回日期:2022-06-02 出版日期:2022-11-01 发布日期:2022-11-03
  • 通讯作者: 汪玉红
  • 作者简介:张沈懿，硕士，Email：2019224035147@stu.scu.edu.cn
  • 基金资助:
    国家自然科学基金(82071124)

Oral beta-carotene in the treatment of non-erosive oral lichen planus: a randomized controlled trial

Zhang Shenyi1(),Wang Xiangjian1,2,Shi Liran1,Shi Jiahong1,Wang Yuhong1,3(),Zhou Hongmei1   

  1. 1.State Key Laboratory of Oral Diseases & National Center of Stomatology & National Clinical Research Center for Oral Diseases & Frontier Innovation Center for Dental Medicine Plus & Dept. of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China
    2.Dept. of Oral Medicine, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310009, China
    3.Dept. of Oral Medicine, School of Stomatology, The Air Force Medical University, Xi’an 710032, China
  • Received:2022-02-05 Revised:2022-06-02 Online:2022-11-01 Published:2022-11-03
  • Contact: Yuhong Wang
  • Supported by:
    National Natural Science Foundation of China(82071124)

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摘要：

目的 设计并实施一项随机对照临床试验，以明确口服β-胡萝卜素治疗非糜烂型口腔扁平苔藓（OLP）的疗效及安全性。 方法 将74例临床表现为广泛白色病损的非糜烂型OLP患者随机分为2组。试验组（38例）口服β-胡萝卜素软胶囊，每次6 mg，每天1次；对照组（36例）口服维生素E软胶囊，每次100 mg，每天1次。2组的疗程均为6个月。于治疗前、用药3个月、用药6个月分别记录白色病损面积、角化程度、疼痛指数及不良反应。白色病损基本消退者进入复发观察阶段。 结果 用药3个月和6个月后，β-胡萝卜素组在改善白纹面积（3个月和6个月均P<0.001）及角化程度（3个月时P=0.018，6个月时P=0.001）方面均优于维生素E组，但在改善疼痛方面差异无统计学意义（P>0.05）。2组均未发生严重不良反应。2组复发率的差异无统计学意义（P>0.05）。 结论 β-胡萝卜素可以作为一种安全有效的替代药物治疗非糜烂型OLP。

关键词: 口腔扁平苔藓, β-胡萝卜素, 维生素E, 白纹病损, 非糜烂型

Abstract:

Objective This study aims to illustrate the efficacy and safety of oral beta-carotene in the treatment of non-erosive oral lichen planus (OLP) by designing and conducting a randomized controlled clinical trial. Methods A total of 74 patients with non-erosive OLP and widespread white lesions were randomized into the experimental group (n=38) who received oral beta-carotene soft capsules (6 mg p.o. q.d.) or the control group (n=36) who received oral vitamin E soft capsules (100 mg p.o. q.d.) for 6 months continuously. Then, the white area, keratotic degree, pain level, and adverse effects were recorded at the first visit and after 3 and 6 months of treatment. If the white lesions disappeared, any recurrence du-ring the follow-up period was recorded. Results The final diminution in white lesion areas (both P<0.001) and keratotic degree scores (P=0.018, P=0.001) were significantly greater with beta-carotene than with vitamin E after 3 and 6 months of treatment, respectively. However, the intergroup differences in the reduction of pain level were not significant (P>0.05). No severe adverse reactions were found in both groups. Recurrence rates did not significantly differ between groups (P>0.05). Conclusion Oral beta-carotene is an effective and safe alternative for the treatment of non-erosive OLP.

Key words: oral lichen planus, beta-carotene, vitamin E, white lesions, non-erosive type

中图分类号: 

  • R 781.5

图 1

OLP白色病损角化程度的图像化半定量评分系统0：正常（口腔黏膜正常，无白色病损）；1：角化程度轻度增高（白色病损稀疏浅淡）；2：角化程度中度增高（白色病损相对密集）；3：角化程度高（白色病损密集）。"

图 2

试验过程流程图"

表 1

入组受试者基线特征的比较"

测量项目试验组（n=38）对照组（n=36）P值
年龄/岁xˉ±s40.6±12.741.2±11.10.824
范围18.0~60.021.0~60.0
性别/例（%）男17（44.7）15（41.7）0.790
女21（55.3）21（58.3）
病程/月xˉ±s16.6±7.917.0±10.80.825
范围2.0~36.02.0~48.0
白色病损面积/cm2xˉ±s11.6±6.39.8±5.30.252
角化程度评分xˉ±s2.2±0.62.4±0.50.404
NRS评分xˉ±s1.9±1.02.0±1.10.421

表 2

完成试验者白色病损面积、角化程度及NRS评分的比较"

测量项目观察期分组例数下四分位数中位数上四分位数Z值P值
白色病损面积/cm2治疗前

试验组

对照组

33

34

6.4

5.2

10.0

8.7

14.9

12.5

-1.186a0.236
治疗3个月后

试验组

对照组

33

34

0.8

2.5

2.2

4.8

5.3

11.1

-4.918b

-4.623b

0.000

0.000

3个月内差值

试验组

对照组

33

34

3.8

0.5

6.1

1.4

11.0

4.8

-3.903a0.000
治疗6个月后

试验组

对照组

33

34

0.0

0.0

0.0

2.5

0.6

8.3

-5.012b

-5.087b

0.000

0.000

6个月内差值

试验组

对照组

33

34

5.9

2.6

9.1

4.1

14.3

8.2

-3.945a0.000
角化程度评分治疗前

试验组

对照组

33

34

2.0

2.0

2.0

2.0

3.0

3.0

-0.860a0.390
治疗3个月后

试验组

对照组

33

34

1.0

1.0

1.0

1.0

1.0

2.0

-5.248b

-5.488b

0.000

0.000

3个月内差值

试验组

对照组

33

34

1.0

1.0

1.0

1.0

1.0

1.0

-2.358a0.018
治疗6个月后

试验组

对照组

33

34

0.0

0.0

0.0

1.0

1.0

2.0

-5.143b

-4.466b

0.000

0.000

6个月内差值

试验组

对照组

33

34

1.5

0.0

2.0

1.0

2.0

2.0

-3.295a0.001
NRS评分治疗前

试验组

对照组

33

34

1.0

2.0

2.0

2.0

3.0

3.0

-0.762a0.446
治疗3个月后

试验组

对照组

33

34

1.0

1.0

2.0

2.0

3.0

3.0

-0.046b

-1.547b

0.963

0.122

3个月内差值

试验组

对照组

33

34

-1.0

0.0

0.0

0.0

1.0

1.0

-1.082a0.279
治疗6个月后

试验组

对照组

33

34

1.0

1.8

2.0

2.0

2.0

3.0

-0.778b

-0.688b

0.437

0.491

6个月内差值

试验组

对照组

33

34

-0.5

0.0

0.0

0.0

1.0

1.0

-0.162a0.871

图 3

口服β-胡萝卜素治疗3个月和6个月后疗效展示A、B：初诊时，双颊黏膜广泛白色病损（网纹型和丘疹型），白色病损总面积25.17 cm2，角化程度评分2分；C、D：治疗3个月后，双颊白色病损部分消退、色泽变淡，总面积降低为10 cm2，角化程度评分1分；E、F：治疗6个月后，双颊白色病损基本消退。图中黑色虚线示白纹范围；黑色箭头示角化程度较高病损。"

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