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替普罗珠单抗治疗活动性甲状腺眼病的荟萃分析。

Teprotumumab for treating active thyroid eye disease: A meta-analysis.

作者信息

Cong Xiangguo, Pei Leilei, Hu Honglei

机构信息

Department of Endocrinology, The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital, Suzhou, China.

Department of Endocrinology, Sunshine Union Hospital, Weifang, China.

出版信息

Medicine (Baltimore). 2025 Jun 27;104(26):e42966. doi: 10.1097/MD.0000000000042966.

Abstract

BACKGROUND

Thyroid eye disease (TED) is a disabling, organ-specific autoimmune disease that is a global health concern. Recently, certain biological agents have demonstrated unique advantages for the treatment of TED. Teprotumumab is an emerging biological agent used for TED treatment. This study assessed whether teprotumumab can serve as an effective and safe treatment for active TED through a meta-analysis of the literature.

METHODS

We searched 4 databases (PubMed, The Cochrane Library, Web of Science, and Embase) for randomized controlled trials regarding the treatment of Graves' ophthalmopathy by teprotumumab by March 31, 2024. We screened the literature library and extracted the data according to the inclusion and exclusion criteria.

RESULTS

Our study included 5 articles that involved 411 cases. Significant differences were reported in the change from baseline in proptosis (proptosis vs baseline), diplopia response at week 24, and clinical activity score of 0 or 1 at week 24 in the teprotumumab versus placebo group. The teprotumumab group reported no significant risk of adverse events or serious adverse events during the intervention.

CONCLUSION

Teprotumumab significantly decreased proptosis and clinical activity score and improved diplopia response in patients with TED, with fewer adverse effects. Therefore, it is a promising biological agent. However, this conclusion should be further validated by high-quality, long-term randomized controlled trials with large sample sizes.

摘要

背景

甲状腺眼病(TED)是一种致残性的器官特异性自身免疫性疾病,是全球关注的健康问题。最近,某些生物制剂在治疗TED方面显示出独特优势。替普罗单抗是一种用于治疗TED的新兴生物制剂。本研究通过对文献的荟萃分析评估替普罗单抗是否可作为活动性TED的有效且安全的治疗方法。

方法

我们检索了4个数据库(PubMed、Cochrane图书馆、科学网和Embase),以查找截至2024年3月31日关于替普罗单抗治疗格雷夫斯眼病的随机对照试验。我们根据纳入和排除标准筛选文献库并提取数据。

结果

我们的研究纳入了5篇文章,涉及411例病例。替普罗单抗组与安慰剂组在眼球突出度较基线的变化(眼球突出度与基线相比)、第24周的复视反应以及第24周临床活动评分为0或1方面存在显著差异。替普罗单抗组在干预期间未报告不良事件或严重不良事件的显著风险。

结论

替普罗单抗可显著降低TED患者的眼球突出度和临床活动评分,并改善复视反应,且不良反应较少。因此,它是一种有前景的生物制剂。然而,这一结论应通过高质量、大样本量的长期随机对照试验进一步验证。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fcf1/12212777/aca18c00bf11/medi-104-e42966-g001.jpg

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