菌酸和新发的全身性红斑狼:一项随机临床试验
Yijun You1, Zhuochao Zhou1, Fan Wang1
1Department of Rheumatology and Immunology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
JAMA network open
|September 16, 2024
概括
早期使用mycophenolate mofetil (MMF) 显著降低了新发全身性红斑狼 (SLE) 患者的严重发作和狼性炎 (LN) 发生率,这些患者具有高抗dsDNA抗体标位. 与标准护理相比,这种治疗显示出更好的结果.
科学领域:
- 类风湿病学 类风湿病学
- 免疫学 免疫学 免疫学
- 临床试验 临床试验
背景情况:
- 抗双链DNA (dsDNA) 抗体与系统性红斑狼 (SLE) 爆发和狼性炎 (LN) 病变发生有关.
- 早期使用mycophenolate mofetil (MMF) 预防SLE爆发的疗效尚不清楚.
研究的目的:
- 在SLE患者中,评估MMF与普得尼松和化硫酸盐相结合的疗效和安全性,而不是单独使用普得尼松和化硫酸盐.
- 评估货币市场基金在预防SLE爆发和减少LN发病率方面的潜力.
主要方法:
- 一个多中心,观察者盲目的随机临床试验,涉及130名未接受治疗的SLE患者,具有高抗dsDNA抗体标位,没有主要器官参与.
- 参与者接受了标准护理 (普得尼松+基硫酸盐) 或标准护理加MMF96周.
- 主要结局:发生爆发的患者比例 (SELENA-SLEDAI爆发指数). 二级结局包括低疾病活性,生活质量,不良事件和SLEDAI评分.
主要成果:
- 与对照组 (27.7%) 相比,货币市场基金组的严重爆发风险明显较低 (10.8%).
- 狼性炎 (LN) 的发生率在MMF组 (1.5%) 与对照组 (13.8%) 相比显著较低.
- 在这两组中常见的严重不良事件是感染,在金钱市场基金和对照组中发生率相似.
结论:
- 早期使用MMF似乎有效地减少新发SLE患者的严重爆发和LN发病率,这些患者具有高抗dsDNA抗体标位.
- 对于这种患者群体来说,MMF是标准治疗的潜在有价值的补充.
- 进一步的研究可能会探索长期结果和最佳的MMF剂量策略.
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