静脉注射单克隆抗体治疗中重度活动期格雷夫斯眼病的疗效和安全性：系统评价和荟萃分析。
Efficacy and Safety of intravenous monoclonal antibodies in patients with moderate-to-severe active Graves'ophthalmopathy: a systematic review and meta-analysis.
机构信息
Laboratory of Endocrinology and Metabolism/Department of Endocrinology and Metabolism, Rare Disease Center, West China Hospital, Sichuan University, Chengdu, China.
Department of Endocrinology and Metabolism, Chengdu First People's Hospital, Chengdu, China.
出版信息
Front Endocrinol (Lausanne). 2023 May 23;14:1160936. doi: 10.3389/fendo.2023.1160936. eCollection 2023.
BACKGROUNDS
The effects of various treatments on Graves' ophthalmopathy (GO) have been studied. As monoclonal antibodies (mAbs) have been proposed for the treatment of moderate to severe GO, direct comparisons between different mAbs are lacking.We therefore conducted this meta-analysis to objectively compare the efficacy and safety of intravenous mAbs.
METHODS
To identify eligible trials, references published before September 2022 were electronically searched in PubMed, Web of Science, Pubmed, Embase,Cochrane Library, CBM, CNKI,Wan-Fang and ICTRP databases.The Newcastle-Ottawa scale (NOS) and the Cochrane Risk of Bias Assessment Tool were used to assess the risk of bias of the original studies.The primary and secondary outcomes were the response and inactivation rates, with the secondary outcomes being the clinical activity score (CAS),the improvement of proptosis and diplopia improvement,and the adverse event rate. Publication bias was evaluated, along with subgroup and sensitivity analyses.
RESULTS
A total of 12 trials with 448 patients were included. The meta-analysis showed that TCZ (tocilizumab) was most likely to be the best treatment in terms of response according to indirect contrast, followed by TMB (teprotumumab) and RTX (rituximab).TCZ, followed by TMB and RTX, was also most likely to be the best treatment in terms of reducing proptosis. In terms of improving diplopia, TMB was most likely to be the best treatment, followed by TCZ and RTX.TCZ was the highest probability of safety, followed by RTX and TMB.
CONCLUSIONS
Based on the best available evidence,TCZ should be the preferred treatment for moderate to severe GO.In the absence of head-to-head trials,indirect comparisons of treatments are routinely used to estimate the effectiveness of the treatments of interest. In addition,the optimal dose and potential mechanism of action of monoclonal antibodies remain to be established,and it is encouraging that the treatment paradigm for GO may change in the future.This study was designed in accordance with the Preferred Reporting Items for conducting Systematic Reviews and Meta-Analyses (PRISMA)(27).
SYSTEMATIC REVIEW REGISTRATION
http://www.crd.york.ac.uk/prospero, identifier CRD42023398170.
背景
已经研究了各种治疗方法对格雷夫斯眼病（GO）的影响。由于单克隆抗体（mAbs）已被提议用于治疗中重度 GO，因此缺乏不同 mAbs 之间的直接比较。因此，我们进行了这项荟萃分析，以客观比较静脉内 mAbs 的疗效和安全性。
方法
为了确定合格的试验，我们在 PubMed、Web of Science、Pubmed、Embase、Cochrane Library、CBM、CNKI、Wan-Fang 和 ICTRP 数据库中电子检索了截至 2022 年 9 月之前发表的参考文献。使用纽卡斯尔-渥太华量表（NOS）和 Cochrane 偏倚风险评估工具评估原始研究的偏倚风险。主要和次要结局是反应和失活率，次要结局是临床活动评分（CAS）、眼球突出度的改善和复视的改善以及不良事件发生率。评估了发表偏倚，并进行了亚组和敏感性分析。
结果
共纳入 12 项试验，共 448 例患者。荟萃分析显示，根据间接对照，TCZ（托珠单抗）最有可能成为反应最佳的治疗方法，其次是 TMB（替普珠单抗）和 RTX（利妥昔单抗）。TCZ 最有可能成为降低眼球突出度的最佳治疗方法，其次是 TMB 和 RTX。在改善复视方面，TMB 最有可能成为最佳治疗方法，其次是 TCZ 和 RTX。TCZ 的安全性最高，其次是 RTX 和 TMB。
结论
根据现有最佳证据，TCZ 应成为中重度 GO 的首选治疗方法。在缺乏头对头试验的情况下，常规使用间接比较来估计感兴趣治疗方法的疗效。此外，单克隆抗体的最佳剂量和潜在作用机制仍有待确定，令人鼓舞的是，GO 的治疗模式可能会在未来发生变化。本研究按照系统评价和荟萃分析的首选报告项目（PRISMA）（27）进行设计。
系统评价注册
http://www.crd.york.ac.uk/prospero，标识符 CRD42023398170。
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