一项前性纵向观察性研究,对多发性硬化症患者进行了为期两年的随访,这些患者接受了克拉迪宾的治疗
Jasem Al-Hashel1, Samar Farouk Ahmed2, Malak AlMojel3
1Department of Neurology, Ibn Sina Hospital, P.O. Box 25427, Safat 13115, Kuwait; Department of Medicine, Faculty of Medicine, Kuwait University, P.O. Box 24923, Safat 13110, Kuwait.
Clinical neurology and neurosurgery
|July 17, 2023
概括
在多发性硬化症 (MS) 患者的两年内,克拉迪宾治疗显著减少了复发和MRI活性. 这项观察性研究发现克拉迪宾是安全的,有效的,并与有利的结果相关,特别是当早期开始时.
科学领域:
- 神经学 神经学
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
背景情况:
- 多发性硬化症 (MS) 治疗景观.
- 关于cladribine有效性和安全性的有限的现实世界数据.
- 需要长期的观察性研究.
研究的目的:
- 在两年内评估克拉迪宾在MS患者的有效性和安全性.
- 评估复发率,残疾进展和MRI活动.
- 确定实现没有疾病活动证据3 (NEDA-3) 的患者比例.
主要方法:
- 观察性,纵向的前性研究.
- 包括复发性复发性MS患者,在克拉迪宾治疗后进行了为期两年的随访.
- 主要终点:没有复发的患者;次要终点:ARR,EDSS变化,MRI活动,NEDA-3和不良事件 (AE).
主要成果:
- 85%的患者没有复发,显著改善 (P < 0.001).
- 年复发率 (ARR) 显著降低 (0.15对0.85,P<0.01).
- 90%的人没有出现残疾进展;75%的人达到NEDA-3. 显著降低MRI活动 (T2病变,加多增强).
- 不良事件包括感染 (8.4%),淋巴细胞减少 (4.2%) 和肝酶升高 (1.4%).
结论:
- 克拉迪宾治疗显著降低了MS中复发率和MRI活性.
- 治疗表明了有利的安全性和耐受性.
- 早期启动克拉迪宾与更好的患者结果有关.
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