狼性炎的低初始口服葡萄糖皮质体剂量与高初始口服葡萄糖皮质体剂量:对随机对照临床试验的综合分析
Amit Saxena1, Cristina Sorrento2, Peter Izmirly2
1Department of Medicine, Dvision of Rheumatology, NYU Grossman School of Medicine, New York City, New York, USA amit.saxena@nyumc.org.
较低的初始口服葡萄糖皮质激素 (GC) 剂量与治疗狼性炎 (LN) 的高剂量一样有效,严重不良事件较少. 这一发现支持在LN管理中使用降低的GC剂量.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學.
- 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:
- 传统的狼性炎 (LN) 治疗包括高剂量的口服葡萄皮质类药物 (GC),高达1.0毫克/公斤/天的普雷尼松.
- 最近的指导方针建议在静脉脉冲治疗后,较低的初始口服GC剂量.
- 缺乏对低剂量与高剂量初始口服GC的直接比较研究.
研究的目的:
- 为了比较低剂量与高剂量初始口服葡萄糖皮质体 (GC) 在狼性炎 (LN) 治疗中的疗效和安全性.
- 分析来自随机对照试验 (RCT) 的汇总数据,评估不同的GC剂量策略.
- 为临床实践提供有关在LN管理中最佳GC启动的信息.
主要方法:
- 来自五项随机对照试验 (RCT) 的数据的聚合分析.
- 患者接受低剂量 (≤0.5毫克/公斤/天普得尼松) 与高剂量 (1.0毫克/公斤/天普得尼松) 的患者初始口服GC的比较.
- 在12个月评估的结果包括完全反应 (CRR 0.5),CRR或部分反应 (PRR) 和严重不良事件 (SAE).
主要成果:
- 在低剂量 (25.2%) 和高剂量 (27.2%) GC组之间,12个月后完全反应 (CRR 0.5) 没有显著差异 (p=0.54).
- 观察到类似的CRR或部分反应 (PRR):低剂量组中的48.7%,高剂量组中的43.6% (p=0.14).
- 低剂量GC组的严重不良事件 (SAE) 与高剂量组 (31.6%) 相比 (19.4%) 显著较低 (p<0.001),包括感染相关的SAE (9.8%与16.5%,p=0.012).
结论:
- 在静脉脉冲治疗后,低剂量初始口服GC显示了12个月后与狼性炎 (LN) 高剂量GC相比较的反应率.
- 使用较低初始口服GC剂量的治疗与严重不良事件的发生率降低有关.
- 这些发现支持在治疗狼性炎时采用较低的初始口服GC剂量.
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