在微观多血管炎中诱导缓解 (EMSAR-MPA试验):随机对照试验的研究协议
Sijia Li1, Shulei Yao1, Xuan Tie1
1Division of Nephrology, Shanxi Medical University Second Hospital, Shanxi Kidney Disease Institute, Taiyuan, Shanxi, People's Republic of China.
BMJ open
|March 12, 2024
概括
这项研究评估了甲 (EC-MPS) 与环胺 (CYC) 对抗微观多炎 (MPA) 的治疗. 作为MPA缓解诱导的安全和有效替代方案,EC-MPS显示出希望.
科学领域:
- 类风湿病学 类风湿病学
- 免疫抑制是一种免疫抑制.
- 临床试验 临床试验
背景情况:
- 抗中性粒细胞质抗体 (ANCA) 相关的血管炎 (AAV) 需要有效的免疫抑制.
- 甲酸莫菲蒂尔 (MMF) 是用于AAV诱导疗法的环胺 (CYC) 或瑞图西马布的潜在替代品.
- 肠涂层基酸 (EC-MPS) 是为了减轻MMF的胃肠道副作用而开发的.
研究的目的:
- 评估EC-MPS与葡萄糖皮质类药物结合的疗效和安全性,用于治疗活跃的,不危及生命的微观多炎 (MPA).
- 将EC-MPS与CYC作为MPA的诱导疗法进行比较.
主要方法:
- 一个多中心的,开放的,随机对照的,非劣势性试验,涉及110名活跃,不危及生命的MPA患者.
- 患者被随机分配 (1:1) 接受口服EC-MPS (720-1440毫克/天) 或静脉脉冲CYC (7.5-15毫克/公斤) 3-6个月,以及标准化葡萄糖皮质激素治疗方案.
- 在缓解后,两组在18个月的研究期间的剩余时间内都过渡到口服阿扎西奥普林.
主要成果:
- 主要疗效终点是6个月后的缓解率.
- 这项研究还将评估诱导疗法对18个月随访期间复发率的影响.
结论:
- 这项试验将为EC-MPS与MPA诱导的CYC相比提供关键数据.
- 研究结果将为临床实践提供有关MPA.更安全和潜在更耐受的免疫抑制策略的信息.
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