对比甲状腺素单疗法与甲状腺素加莱诺米德组合治疗银病关节炎 (COMPLETE-PsA):一项双盲,安慰剂控制,随机化,双盲试验
Michelle L M Mulder1, Johanna E Vriezekolk2, Tamara W van Hal1
1Department of Rheumatology, Sint Maartenskliniek, Nijmegen, Netherlands; Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.
The Lancet. Rheumatology
|January 30, 2024
概括
与甲索特雷克萨特加上莱夫卢诺米德的联合治疗明显改善了牛皮性关节炎疾病的活性,而不是单独使用甲索特雷克萨特. 然而,这种联合治疗与更多的不良事件有关.
科学领域:
- 类风湿病学 类风湿病学
- 临床试验 临床试验
- 药理学 药理学是指药理学的学科.
背景情况:
- 传统的合成疾病修饰性抗风湿药物 (DMARDs) 是牛皮关节炎的第一线治疗方法.
- 传统合成DMARD组合的疗效证据有限.
- 这项研究调查了甲状腺和莱夫卢诺米德与甲状腺单一治疗在牛皮关节炎的疗效.
研究的目的:
- 为了确定组合疗法 (甲基和莱夫卢诺) 是否优于甲基单一疗法在改善牛皮关节炎患者的疾病活性方面.
- 评估组合治疗的安全性和耐受性.
主要方法:
- 一个单中心,双盲,随机,安慰剂对照试验,涉及78名牛皮关节炎患者.
- 患者被随机分配,接受甲状腺素加勒比胺或甲状腺素加安慰剂.
- 主要结局是第16周牛皮关节炎疾病活动评分 (PASDAS) 的差异.
主要成果:
- 与单一治疗相比,组合治疗在第16周显示PASDAS在统计学上显著改善 (3.1对3.7,p=0.025).
- 没有研究死亡发生.
- 不良事件,包括恶心,吐和氨酸转移酶的升高,在组合治疗组中更为频繁.
结论:
- 甲索特雷克萨特加上莱夫卢诺米德的联合疗法在牛皮关节炎疾病活动中提供了更大的改善.
- 组合疗法比单独使用甲状腺素治疗更难耐受,不良事件的发生率更高.
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