利图西马布治疗作为二线疗法在葡萄糖皮质醇不响应的坟墓的轨道病:一个非随机的,受控的,干预性研究
Sofia Manousou1, Mats Holmberg2, Elin Ekdahl3
1Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Department of Endocrine Research, Blå Stråket, Sahlgrenska University Hospital, Göteborg, Sweden; Wallenberg Centre for Molecular and Translational Medicine, Västra Götalands Region, Sweden; Department of Cardiology and Diabetes, Högsbo Hospital, Västra Frölunda, Sweden.
概括
与继续服用葡萄糖皮质类药物相比,早期转换为Graves轨道病的Rituximab并没有改善临床活动得分或生活质量. 这项研究表明,早期的rituximab对于中度至重度病例的标准护理并不优越.
科学领域:
- 眼科医生 眼科 眼科
- 免疫学 免疫学 免疫学
- 内分泌学 在内分泌学.
背景情况:
- 格雷夫斯轨道病 (GO) 是一种影响眼睛的自身免疫性疾病.
- 利图西马布是适度至严重的GO不对静脉注射葡萄糖皮质类药物反应的推第二线疗法.
- 有限且相互矛盾的数据存在于Rituximab作为早期二线治疗的有效性.
研究的目的:
- 评估Rituximab作为Graves轨道病的早期二线治疗方法.
- 为了比较早期rituximab与持续的葡萄糖皮质醇治疗的结果.
主要方法:
- 一项非随机的,受控的,干预性研究,涉及Graves轨道病患者.
- 患者最初接受了静脉注射的葡萄皮质类药物;没有反应 (CAS改善<2分) 的患者被转换为rituximab (NR-RTX组).
- 对照组包括那些持续服用葡萄糖皮质激素的患者 (R-GC组) 和接受定期护理的患者 (NR-RC组) 的回顾性对照.
- 临床活动评分 (CAS),生活质量 (QoL) 和安全性在68周内进行了评估.
主要成果:
- 与R-GC组相比,NR-RTX组在CAS或QoL方面没有显著的优势.
- 虽然最初的CAS在各组之间略有差异,但随着时间的推移,得分趋同.
- 对于QoL,没有观察到重要的治疗或时间效应.
结论:
- 在中度至重度的格雷夫斯轨道病变中,早期切换为rituximab并没有在CAS或QoL方面取得优异的结果,而不是与持续的静脉注射葡萄糖皮质激素治疗相比.
- 目前对利图西马布作为二线治疗的建议仍然适用于没有反应的患者.
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