国际口腔医学杂志

国际口腔医学杂志 ›› 2026, Vol. 53 ›› Issue (1): 51-58.doi: 10.7518/gjkq.2026206

• 论著 • 上一篇    下一篇

局部应用环孢素治疗口腔扁平苔藓的有效性和安全性的Meta分析

汪星(),李莎,郭锦材()   

  1. 长沙市口腔医院药剂科 湖南中医药大学口腔医学院 长沙 410006
  • 收稿日期:2024-07-22 修回日期:2025-08-28 出版日期:2026-01-01 发布日期:2025-12-31
  • 通讯作者: 郭锦材
  • 作者简介:汪星，主管药师，硕士，Email：342117383@qq.com
  • 基金资助:
    湖南省自然科学基金(2024JJ9532);湖南中医药大学校院联合基金项目(2022XYLH134)

Meta-analysis of the efficacy and safety of topical cyclosporine in the treatment of oral lichen planus

Xing Wang(),Sha Li,Jincai Guo()   

  1. Dept. of Pharmacy, Changsha Stomatological Hospital; School of Stomatology, Hunan University of Chinese Medicine, Changsha 410006, China
  • Received:2024-07-22 Revised:2025-08-28 Online:2026-01-01 Published:2025-12-31
  • Contact: Jincai Guo
  • Supported by:
    Nature Science Foundation of Hunan Province(2024JJ9532);Hunan University of Chinese Medicine Research Fund Project(2022XYLH134)

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摘要：

目的 评价局部应用环孢素治疗口腔扁平苔藓（OLP）的有效性和安全性，为临床合理用药提供参考。 方法 计算机检索PubMed、Embase、The Cochrane Library、Web of Science、中国知网、万方和维普等数据库，并在线检索欧洲灰色文献信息系统（SIGLE）和ClinicalTrials网站，搜集所有关于环孢素治疗OLP的随机对照试验（RCT），检索时限均从建库至2023年3月25日。由2名评价者独立评价研究质量和提取数据，采用RevMan 5.4和STATA14.0软件进行Meta分析。 结果 共纳入7项环孢素治疗OLP的RCT研究，包括317名患者。其中6项为比较环孢素和糖皮质激素，１项为比较环孢素和安慰剂。Meta分析结果显示，环孢素组和激素组临床有效率差异无统计学意义［风险比（RR）=0.87，95%置信区间（CI）：0.67~1.14，P=0.32］。治疗4周后，环孢素组和激素组疼痛评分改善差异无统计学意义（标准化均数差=-0.23，95%CI：-0.54~0.07，P=0.13）。环孢素组和激素组的不良反应发生率相比，差异无统计学意义（RR=0.71，95%CI：0.18~2.79，P=0.62）。 结论 当前证据显示，与糖皮质激素相比，环孢素在临床有效率、疼痛评分改善和安全性方面无优势。受纳入研究数量和质量的限制，上述结论还需更多高质量研究予以验证。

关键词: 口腔扁平苔藓, 环孢素, 系统评价, Meta分析

Abstract:

Objective　This study aimed to evaluate the efficacy and safety of topical cyclosporine in the treatment of oral lichen planus (OLP) and to provide reference for clinicians. Methods　Databases, such as Pubmed, Embase, The Cochrane Library, Web of Science, CNKI, WanFang Data, and VIP, were searched. The System for Information on Grey Li-terature in Europe (SIGLE) and ClinicalTrials websites were searched online to collect randomized controlled trials (RCTs) of cyclosporine for OLP from the establishment of the database to March 25, 2023. Two reviewers independently evalua-ted the study quality and extracted data, and meta-analysis was performed using RevMan (version 5.4) and STATA (version 14.0) software. Results　A total of seven RCT studies on cyclosporine in the treatment of OLP were included, including 317 patients. Among them, six compared cyclosporine with corticosteroid, and one compared cyclosporine with placebo. Meta-analysis results showed no statistically significant difference in clinical effectiveness between the cyclosporine and corticosteroid groups [risk ratio (RR)=0.87, 95% confidence interval (CI): 0.67-1.14, P=0.32]. After 4 weeks of treatment, no statistically significant difference was observed in the improvement of pain scores between the cyclosporine and corticosteroid groups (standardized mean difference=-0.23, 95%CI: -0.54-0.07, P=0.13). No statistically significant difference was found in the incidence of adverse reactions between the cyclosporine and corticosteroid groups (RR=0.71, 95%CI: 0.18-2.79, P=0.62). Conclusion　Current evidence shows that cyclosporine has no advantage over corticosteroid in terms of clinical efficacy, improvement in pain scores, and safety. More high-quality studies are required to verify the above conclusion due to limitations in the quantity and quality of included studies.

Key words: oral lichen planus, cyclosporine, systematic review, Meta-analysis

中图分类号: 

  • R781.5

表 1

PubMed 检索策略"

步骤检索策略
1“Lichen Planus, Oral”[Mesh]
2(Oral Lichen Planus) OR (OLP)

3

4

5

6

1 OR 2

“Cyclosporine”[Mesh]

(((((((((((((((Cyclosporine A) OR (Cyclosporin A)) OR (Ciclosporin)) OR (Cyclosporin)) OR (Neoral)) OR (Sandimmun Neoral)) OR (CyA-NOF)) OR (CyA NOF)) OR (Sandimmune)) OR (Sandimmun)) OR (CsA-Neoral)) OR (CsA Neoral)) OR (CsANeoral)) OR (OL 27-400)) OR (OL 27 400)) OR (OL 27400)

3 AND (4 OR 5)

图 1

文献筛选流程及结果"

表 2

纳入研究的基本特征"

纳入研究国家例数（T/C）

平均年龄/

（T/C，岁）

性别（男/女，例）干预措施疗程随访时间结局指标
TCTC
Georgaki 2022[6]希腊14/1859.6/61.85/94/14100 mg/mL环孢素漱口2 mg/5 mL地塞米松漱口4周5个月②③④
Conrotto 2006[7]意大利20/1963.4/67.959/115/141.5%环孢素软膏涂抹0.025%氯倍他索软膏涂抹2个月2个月①④
Yoke 2006[8]新加坡，韩国，印度，泰国66/7143.5/43.925/4320/51100 mg/mL环孢素涂抹0.1%曲安奈德8周1年①③④
Sieg 1995[9]德国6/751.35/8100 mg/mL环孢素漱口0.1%曲安奈德软膏6周1年②④
López López[10]西班牙10/10---10%环孢素溶液漱口0.1%曲安奈德水溶液8周1年①
Eisen 1990[11]美国8/863/612/65/3100 mg/mL环孢素漱口安慰剂8周8个月③

孙玉亮

2013[12]

中国30/3044.3/46.816/1412/18环孢素软胶囊涂抹氟轻松软膏6周3个月①③④

表 3

纳入研究的偏倚风险评价结果"

纳入研究随机方法分配隐藏对研究者和受试者施盲对结局测量者施盲

结果数据

的完整性

选择性报告研究结果其他偏倚来源
Georgaki 2022[6]不清楚不清楚是不清楚完整不清楚不清楚
Conrotto 2006[7]计算机随机不清楚是不清楚完整不清楚不清楚
Yoke 2006[8]不清楚电话或密闭信封不清楚不清楚完整不清楚不清楚
Sieg 1995[9]不清楚不清楚不清楚不清楚完整不清楚不清楚
López López 1995[10]不清楚不清楚是不清楚完整不清楚不清楚
Eisen 1990[11]随机数字表不清楚是不清楚完整不清楚不清楚
孙玉亮2013[12]随机数字表不清楚不清楚不清楚完整不清楚不清楚

图 2

纳入RCT研究的偏倚风险评估结果"

图 3

环孢素与激素治疗OLP临床有效率的森林图"

图 4

环孢素与激素治疗OLP疼痛评分改善的森林图"

图 5

环孢素与激素治疗OLP不良反应发生率的森林图"

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