沙利度胺治疗复发性阿弗他口炎的疗效和安全性: 一项系统评价

doi:10.5246/jcps.2025.08.056

中国药学(英文版) ›› 2025, Vol. 34 ›› Issue (8): 755-766.DOI: 10.5246/jcps.2025.08.056

沙利度胺治疗复发性阿弗他口炎的疗效和安全性: 一项系统评价

岳姣¹^,^#, 巨佳¹^,^#, 王新文², 林瑶¹, 黄静¹, 马棪斐¹, 刘水冰¹, 冯斌¹^,^*(), 成黎霏¹^,^*()

^1. 口颌系统重建与再生全国重点实验室, 国家口腔疾病临床医学研究中心, 陕西省口腔生物工程技术研究中心, 空军军医大学口腔医院, 药剂科, 陕西西安 710032
^2. 口颌系统重建与再生全国重点实验室, 国家口腔疾病临床医学研究中心, 陕西省口腔生物工程技术研究中心, 空军军医大学口腔医院, 口腔黏膜病科, 陕西西安 710032

收稿日期:2025-04-23 修回日期:2025-05-09 接受日期:2025-05-30 出版日期:2025-08-29 发布日期:2025-08-29
通讯作者: 冯斌, 成黎霏

Efficacy and safety of thalidomide in the treatment of recurrent aphthous stomatitis: A systematic review

Jiao Yue¹^,^#, Jia Ju¹^,^#, Xinwen Wang², Yao Lin¹, Jing Huang¹, Yanfei Ma¹, Shuibing Liu¹, Bin Feng¹^,^*(), Lifei Cheng¹^,^*()

¹ State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, National Clinical Research Center for Oral Diseases, Shaanxi Engineering Research Center for Dental Materials and Advanced Manufacture, Department of Pharmacy, School of Stomatology , The Fourth Military Medical University, Xi’an 710032, Shaanxi, China
² State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, National Clinical Research Center for Oral Diseases, Shaanxi Engineering Research Center for Dental Materials and Advanced Manufacture, Department of Oral Medicine, School of Stomatology, The Fourth Military Medical University, Xi’an 710032, Shaanxi, China

Received:2025-04-23 Revised:2025-05-09 Accepted:2025-05-30 Online:2025-08-29 Published:2025-08-29
Contact: Bin Feng, Lifei Cheng
About author:
^# Jiao Yue and Jia Ju contributed equally to this work.

摘要/Abstract

摘要：

沙利度胺作为一种免疫调节药物, 被广泛推荐用于治疗复发性阿弗他口炎(recurrent aphthous stomatitis, RAS)。本研究旨在评价沙利度胺治疗RAS、白塞病相关的口腔-生殖器溃疡以及HIV感染相关的RAS的疗效。研究基于PICOS (Patient, Intervention, Control, Outcome, Study design)原则进行系统评价, 由于存在异质性, 本文仅进行定性分析, 未进行meta定量分析。共纳入8篇随机对照试验(randomized controlled trials, RCTs)。3项关于RAS的RCTs提示沙利度胺100 mg/d有效, 25 mg/d可延长RAS复发间期。2项关于白塞病相关的口腔-生殖器溃疡的RCTs研究结果显示, 沙利度胺300 mg/d与100 mg/d治疗24周或200 mg/d治疗28天(起始剂量400 mg/d, 连续5天)均有效。3项关于HIV感染相关的RAS的RCTs研究显示, 沙利度胺200 mg/d治疗4周或200 mg/d治疗7周(起始剂量400 mg/d治疗1周)对预防口腔溃疡复发有效, 但100 mg每周3次对预防口腔溃疡复发无效。沙利度胺的不良反应在研究剂量范围内均可耐受。研究表明, 沙利度胺对RAS、白塞病相关的口腔-生殖器溃疡以及HIV感染相关的RAS均有较好的疗效。然而, 由于试验设计、给药剂量和给药疗程的差异, 难以给出沙利度胺最佳有效剂量和给药疗程的推荐, 需要更多高质量的RCTs研究来进一步探索。

关键词: 复发性阿弗他口炎, 沙利度胺, 白塞病, HIV感染, 系统评价

Abstract:

Thalidomide, an immunomodulatory drug, is widely recommended for the treatment of recurrent aphthous stomatitis (RAS). This review aimed to assess the reliability of thalidomide for managing RAS, oro-genital ulcers associated with Behçet’s disease (BD), and RAS in individuals with HIV infection. A systematic review was conducted following PICOS (Patient, Intervention, Control, Outcome, Study design) principles. Given the heterogeneity across studies, a qualitative analysis was performed in place of a meta-analysis. Eight randomized controlled trials (RCTs) were deemed eligible for inclusion. In three RCTs focused on RAS, a dosage of thalidomide at 100 mg/d demonstrated efficacy, while a lower dose of 25 mg/d helped prolong the recurrence interval of RAS. For oro-genital ulcers of BD, two RCTs indicated that both 300 mg/d for 24 weeks and 200 mg/d for 28 d, preceded by an initial dose of 400 mg/d for 5 d, were effective. In three RCTs investigating RAS in HIV-infected patients, thalidomide at 200 mg/d for either 4 or 7 weeks, with an initial dose of 400 mg/d for the first week, proved effective. However, a regimen of 100 mg three times per week failed to prevent the recurrence of oral ulcers. Adverse reactions to thalidomide were generally tolerable within the dosage ranges used in these studies. Overall, thalidomide showed promising efficacy for treating RAS, oro-genital ulcers in BD, and RAS in HIV-infected individuals. However, the variability in trial designs, dosages, and treatment durations makes it challenging to recommend an optimal dose and course of therapy. Further high-quality RCTs are necessary to establish more definitive guidelines.

Key words: Recurrent aphthous stomatitis, Thalidomide, Behcet’s disease, HIV infection, Systematic review

Supporting: attached/file/20250828/20250828170629_522.pdf

岳姣, 巨佳, 王新文, 林瑶, 黄静, 马棪斐, 刘水冰, 冯斌, 成黎霏. 沙利度胺治疗复发性阿弗他口炎的疗效和安全性: 一项系统评价[J]. 中国药学(英文版), 2025, 34(8): 755-766.

Jiao Yue, Jia Ju, Xinwen Wang, Yao Lin, Jing Huang, Yanfei Ma, Shuibing Liu, Bin Feng, Lifei Cheng. Efficacy and safety of thalidomide in the treatment of recurrent aphthous stomatitis: A systematic review[J]. Journal of Chinese Pharmaceutical Sciences, 2025, 34(8): 755-766.

图/表 5

Figure 1. The flow chart of the literature screen process.

Figure 2. The results of risk bias assessment. (A) The assessment of each included study. (B) The proportion statistics of all included studies. The green box indicates a low risk of bias; the yellow box indicates an unclear risk of bias; the red box indicates a high risk of bias.

Table 1. Summary of studies focused on the treatment effect of thalidomide against RAS.

Table 2. Summary of studies focused on the treatment effect of thalidomide against oro-genital ulcers of BD.

Table 3. Summary of studies focused on the treatment effect of thalidomide against RAS in HIV infection.

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沙利度胺治疗复发性阿弗他口炎的疗效和安全性: 一项系统评价

Efficacy and safety of thalidomide in the treatment of recurrent aphthous stomatitis: A systematic review

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