Department of Pharmacy, The First Affiliated Hospital of Chengdu Medical College, Clinical Medical College, Chengdu Medical College, Chengdu, China.
Department of Pharmacy, Changsha Hospital of Traditional Chinese Medicine (Changsha Eighth Hospital), Changsha, China.
Int J Clin Pract. 2023 Aug 8;2023:6638089. doi: 10.1155/2023/6638089. eCollection 2023.
In this study, we conducted a meta-analysis to assess the efficacy and safety of teprotumumab in treating thyroid eye disease. We searched the Cochrane Library, PubMed, and Embase databases from inception to May 25, 2022, and included all randomized controlled trials. Odds ratios (ORs) were calculated using fixed- or random-effect models. A total of three studies involving 341 patients were identified. Overall, the analysis revealed that teprotumumab demonstrated superior integrated proptosis response compared to placebo in both the intention-to-treat (ITT) population (OR = 17.81, 95% CI = [10.32, 30.76], = 50%) and per-protocol population (OR = 24.53, 95% CI = [12.96, 46.45], = 14%). Furthermore, patients receiving teprotumumab showed significant improvement in overall response (OR = 8.35, 95% CI = [4.74, 14.71], = 79%), diplopia response (OR = 5.53, 95% CI = [3.24, 9.44], = 0%), and achieving a clinical activity score (CAS) of 0 or 1 (OR = 6.26, 95% CI = [3.87, 10.12], = 0%). Moreover, patients treated with teprotumumab experienced greater improvements in proptosis (MD = -2.49, 95% CI = [-2.54, -2.45], = 98%) and Graves' ophthalmopathy-specific quality of life (GO-QOL, MD = 11.48, 95% CI = [11.03, 11.93], = 95%). However, it is important to note that patients receiving teprotumumab had a higher risk of adverse events, including serious adverse events, gastrointestinal adverse reactions, and muscle spasms. In summary, teprotumumab demonstrated greater improvement in proptosis response, proptosis, diplopia response, overall response, GO-QOL, and CAS. Nonetheless, it should be considered that its use is associated with a higher risk of adverse events.
在这项研究中，我们进行了一项荟萃分析，以评估 teprotumumab 治疗甲状腺眼病的疗效和安全性。我们检索了 Cochrane 图书馆、PubMed 和 Embase 数据库，检索时间截至 2022 年 5 月 25 日，纳入了所有随机对照试验。使用固定效应或随机效应模型计算比值比（OR）。共纳入了三项涉及 341 名患者的研究。总体而言，分析结果表明，在意向治疗（ITT）人群（OR=17.81，95%CI=[10.32, 30.76]， =50%）和方案人群（OR=24.53，95%CI=[12.96, 46.45]， =14%）中，与安慰剂相比，teprotumumab 显示出更好的综合突眼反应。此外，接受 teprotumumab 治疗的患者在整体反应（OR=8.35，95%CI=[4.74, 14.71]， =79%）、复视反应（OR=5.53，95%CI=[3.24, 9.44]， =0%）和达到临床活动评分（CAS）0 或 1（OR=6.26，95%CI=[3.87, 10.12]， =0%）方面均有显著改善。此外，接受 teprotumumab 治疗的患者突眼（MD=-2.49，95%CI=[-2.54, -2.45]， =98%）和格雷夫斯眼病特异性生活质量（GO-QOL，MD=11.48，95%CI=[11.03, 11.93]， =95%）方面的改善更大。然而，值得注意的是，接受 teprotumumab 治疗的患者发生不良事件的风险更高，包括严重不良事件、胃肠道不良反应和肌肉痉挛。总之，teprotumumab 在突眼反应、突眼、复视反应、整体反应、GO-QOL 和 CAS 方面显示出更大的改善。然而，应该考虑到其使用与更高的不良事件风险相关。
