Lin Shuzhen, Ou Xiaodan, Cai Liangchun, Huang Wenxin, Wen Junping
Fujian Provincial Hospital, Shengli Clinical Medical College of Fujian Medical University, Fujian Medical University, Fuzhou, China.
Department of Endocrinology, Fuzhou University Affiliated Provincial Hospital, Fuzhou, China.
J Endocrinol Invest. 2025 Apr 30. doi: 10.1007/s40618-025-02595-4.
This study aims to investigate efficacy and safety of TCZ in TED.
Performing a meta-analysis of included studies. PubMed, Web of Science, Embase, Cochrane Library, and Clinicatrials.gov databases were retrieved to identify all related published literatures as of May 2024. When I > 50%, the random effect model was used; otherwise, the fixed model was used.
This meta-analysis included 413 patients with TED. Therapeutic effect of TCZ was evaluated by various metrics, including clinical activity score (CAS), response rate, inactivation rate, proptosis, visual acuity (VA), TRAB/TSI levels, diplopia, eye motility, intraocular pressure (IOP), and relapse rate. The final analysis revealed that TCZ significantly reduced CAS (-4.47, 95%CI [-5.14, -3.79]), with high response rate (0.93, 95%CI [0.88, 0.97]) and inactivation rate (0.90, 95%CI [0.83, 0.96]). Significant improvements were also observed in proptosis (2.05 mm reduction, 95%CI [-2.42, -1.67]) and diplopia (0.56 improvement rate, 95% CI [0.40, 0.72]). Regarding safety, the pooled incidence of adverse events (AEs) was 0.31(95%CI [0.15, 0.48]). Hyperlipidemia was the most prevalent AE, followed by neutropenia and infection. Furthermore, subgroup analysis demonstrated TCZ's superior performance in terms of inactivation rate, antibody decline rate, relapse rate, and safety.
According to the best available evidence, TCZ appears to be an acceptable alternative for moderate to severe TED patients due to its significant efficacy, well-tolerability, and low relapse rate. Larger sample size and controlled studies are warranted to promote the position of TCZ in TED treatment.
本研究旨在探讨托珠单抗（TCZ）治疗甲状腺相关眼病（TED）的疗效和安全性。
对纳入的研究进行荟萃分析。检索了PubMed、Web of Science、Embase、Cochrane图书馆和ClinicalTrials.gov数据库，以确定截至2024年5月所有相关的已发表文献。当I>50%时，使用随机效应模型；否则，使用固定模型。
该荟萃分析纳入了413例TED患者。通过多种指标评估了TCZ的治疗效果，包括临床活动评分（CAS）、缓解率、失活率、眼球突出度、视力（VA）、促甲状腺素受体抗体/促甲状腺素免疫球蛋白（TRAB/TSI）水平、复视、眼球运动、眼压（IOP）和复发率。最终分析显示，TCZ显著降低了CAS（-4.47，95%置信区间[-5.14，-3.79]），缓解率高（0.93，95%置信区间[0.88，0.97]），失活率高（0.90，95%置信区间[0.83，0.96]）。眼球突出度（减少2.05mm，95%置信区间[-2.42，-1.67]）和复视（改善率0.56，95%置信区间[0.40，0.72]）也有显著改善。在安全性方面，不良事件（AE）的合并发生率为0.31（95%置信区间[0.15，0.48]）。高脂血症是最常见的AE，其次是中性粒细胞减少和感染。此外，亚组分析表明，TCZ在失活率、抗体下降率、复发率和安全性方面表现更优。
根据现有最佳证据，由于TCZ具有显著疗效、良好耐受性和低复发率，它似乎是中重度TED患者可接受的替代治疗方法。需要更大样本量和对照研究来提升TCZ在TED治疗中的地位。
