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炎症性类风湿病患者感染期间免疫调节剂的持续或暂时中断:随机对照试验
Merel A A Opdam1, Nathan den Broeder1, Reinout van Crevel2
1Department of Rheumatology, Sint Maartenskliniek, Nijmegen, The Netherlands.
概括
在感染期间持续使用免疫调节剂 (IA) 治疗炎症性类风湿性疾病 (IRD) 与中断感染一样安全. 这项研究发现了类似的严重感染率,表明IA延续是IRD患者的可行选择.
科学领域:
- 类风湿病学 类风湿病学
- 传染性疾病 传染性疾病
- 临床试验 临床试验
背景情况:
- 免疫调节剂 (IA) 是炎症性类风湿性疾病 (IRD) 的标准.
- 目前的指导方针建议在感染期间中断IA,但证据有限.
- 在感染期间IA延续与中断的安全性和有效性需要研究.
研究的目的:
- 为了比较持续与暂时中断IA在IRD患者经历感染的结果.
- 评估两种治疗策略中严重感染的风险.
主要方法:
- 进行了一项多中心,开放标签,随机对照试验.
- 在IA的无感染IRD患者被随机分为在感染期间继续或中断IA.
- 主要结局是重症感染患者的比例,在修改治疗意向 (mITT) 群体中进行分析.
主要成果:
- 严重的感染发生在中断组的5.15%和继续组的3.73%中.
- 调整后的风险差异为1.71% (95% CI -1.99至5.39),表明没有显著差异.
- 符合者平均因果效应 (CACE) 分析有利于IA的延续.
结论:
- 暂时中断和延续IA导致IRD患者感染的风险和结果相似.
- 在感染期间继续使用IA似乎是安全的,尽管该研究的统计能力有限.
- 这些发现挑战了目前的指导方针,该指导方针建议在感染期间中止IA.
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