在类风湿性关节炎中分剂与单剂口服甲状腺素:一项随机对照试验 (SMART研究)
Chandra Bhushan Prasad1, Varun Dhir2, Ranjan Gupta3
1Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India.
Clinical rheumatology
|August 29, 2025
概括
与单剂量相比,分剂量口服甲状腺素在16周内显示出更快的临床反应和疗效. 这种疗法还减少了对额外疾病修饰性抗风湿药物的需求,尽管24周后的整体疗效相似.
科学领域:
- 关节病学
- 临床药理学
- 药物经济学
背景情况:
- 药物动力学数据表明分剂口服甲状腺素可以提高生物可用性.
- 缺乏临床证据支持分剂量甲状腺素在类风湿性关节炎 (RA) 中提高疗效.
- 这项研究旨在比较 RA 患者分剂与单剂口服甲醇的临床疗效.
研究的目的:
- 在患有活性类风湿性关节炎的患者中,比较分剂与单剂口服甲状腺素的临床反应.
- 评估不同的口服甲状腺素剂量策略的疗效和安全性.
主要方法:
- 一个实用的,开放的,随机的受控试验,涉及印度六所大学医院的253名血清阳性RA患者.
- 患者被随机分配为每周服用分剂量 (15 mg早上,10 mg晚上) 或单剂量 (25 mg) 甲状腺素.
- 主要结果是24周EULAR良好反应;关键的次要结果是16周EULAR良好反应. 进行了治疗意向分析.
主要成果:
- 在24周的EULAR良好反应中,分剂量和单剂量甲状腺素之间没有显著的差异 (p=0. 263).
- 在16周使用分剂甲状腺时,观察到明显更高的EULAR良好反应 (p=0. 008).
- 在分剂组中需要第二次DMARD的患者数量较少 (p=0. 003),但在数量上发现了更高的转氨酸炎和不耐受性.
结论:
- 与单剂量相比,分剂口服甲醇的疗效更快,并且在16周后减少了对额外的DMARDs的需求,尽管对24周的反应没有达到主要的结果.
- 这项研究提供了证据,表明分剂口服甲状腺素在 RA 中的短期疗效有所改善.
- 在分剂方案中观察到更高的不耐受性和转氨酸炎率.
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