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托珠单抗治疗甲状腺眼病的疗效和安全性:系统评价。

Efficiency and Safety of Tocilizumab for the Treatment of Thyroid Eye Disease: A Systematic Review.

机构信息

Department of Ophthalmology, Centro Hospitalar Universitario Lisboa Central, Lisbon, Portugal.

Department of Ophthalmology, Cuf Descobertas Hospital, Lisbon, Portugal.

出版信息

Ophthalmic Plast Reconstr Surg. 2024;40(4):367-373. doi: 10.1097/IOP.0000000000002573. Epub 2024 Jan 12.

DOI:10.1097/IOP.0000000000002573
PMID:38215463
Abstract

PURPOSE

To review existing literature concerning the effectiveness and safety of tocilizumab (TCZ) for managing thyroid eye disease.

METHODS

A systematic search was conducted across the PubMed and Embase databases to identify studies on TCZ therapy, from inception to May 2023. The search included the keywords "Graves orbitopathy," "thyroid ophthalmopathy," "thyroid eye disease," "thyroid-associated orbitopathy," "thyroid-associated ophthalmopathy," "Graves ophthalmopathy," "endocrine ophthalmopathy," and "Tocilizumab." Only articles written in English, Spanish, or French were considered.

RESULTS

Among the 1,013 articles initially screened, a total of 29 fulfilled the eligibility criteria and were selected. Most studies were case reports or case series, and only one randomized clinical trial was found. TCZ has been used mainly in glucocorticoid-resistant or relapsing cases, with a dosage ranging from 4 or 8 mg/kg every 4 weeks when intravenous or a weekly subcutaneous dose of 162 mg. Treatment duration is usually adjusted to the clinical response. TCZ is mostly effective in reducing inflammatory signs during the active phase of thyroid eye disease, with an improvement of at least 3 points in clinical activity score and an overall relapsing rate of 8.2%. Numerous studies have shown marked reductions in proptosis; although the only available randomized controlled trial reported a nonstatistically significant improvement 6 months after treatment, a recent meta-analysis indicated that TCZ seems to be the most effective treatment for reducing proptosis. No severe side effects related to intravenous or subcutaneous TCZ administration were reported.

DISCUSSION

Despite these promising findings, randomized clinical trials to directly compare the efficacy and safety of TCZ and other currently available therapeutic options are needed.

摘要

目的

回顾关于托珠单抗(TCZ)治疗甲状腺眼病的有效性和安全性的现有文献。

方法

系统检索 PubMed 和 Embase 数据库,从建库到 2023 年 5 月,以识别关于 TCZ 治疗的研究。检索词包括“Graves 眼眶病”、“甲状腺眼病”、“甲状腺眼病”、“甲状腺相关眼眶病”、“甲状腺相关眼病”、“Graves 眼病”、“内分泌眼病”和“托珠单抗”。仅纳入英语、西班牙语或法语撰写的文章。

结果

在最初筛选的 1013 篇文章中,共有 29 篇符合纳入标准。大多数研究为病例报告或病例系列,仅发现一项随机临床试验。TCZ 主要用于糖皮质激素抵抗或复发的病例,静脉注射时剂量为 4 或 8mg/kg,每 4 周一次,或每周皮下注射 162mg。治疗持续时间通常根据临床反应进行调整。TCZ 在甲状腺眼病活动期主要有效降低炎症标志物,临床活动评分至少改善 3 分,总复发率为 8.2%。许多研究表明眶周突出度显著降低;尽管唯一一项可用的随机对照试验报告治疗后 6 个月改善无统计学意义,但最近的一项荟萃分析表明,TCZ 似乎是降低眶周突出度最有效的治疗方法。未报告与静脉或皮下 TCZ 给药相关的严重副作用。

讨论

尽管这些研究结果令人鼓舞,但仍需要开展直接比较 TCZ 和其他现有治疗选择的疗效和安全性的随机临床试验。

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