多西西克林与普得尼索隆作为牛性皮虫的初始治疗策略:实用性,非劣势性,随机对照试验
Hywel C Williams1, Fenella Wojnarowska2, Gudula Kirtschig3
1Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK.
Lancet (London, England)
|March 11, 2017
概括
与口服皮质类固醇相比,多西环林可提供可比的短期囊泡控制. 这项研究发现多西环素对于这种皮肤水泡疾病的患者来说是一个明显更安全的长期治疗选择.
科学领域:
- 皮肤病学
- 临床试验
- 药理学
背景情况:
- 这是一种严重的水泡皮肤疾病,与死亡率的增加有关.
- 目前的标准治疗通常涉及口服皮质类固醇, 具有显著的长期风险.
- 研究替代初步治疗对于改善患者的结果至关重要.
研究的目的:
- 为了比较使用多西环林和口服皮质类固醇开始治疗的疗效.
- 评估多西环素与口服皮质类固醇相比的长期安全性.
- 确定多西环素是否可以在短期内控制泡,同时提供安全优势.
主要方法:
- 进行了一项实用性的多中心并行组随机对照试验.
- 随机分配成年人服用多西西克林 (200 mg/ 天) 或普雷尼索隆 (0. 5 mg/ 公斤/ 天).
- 主要结局包括在6周内控制泡 (不低劣) 和52周治疗相关的不良事件 (安全性).
主要成果:
- 在短时间内控制水泡时,多西环素的效果与普得尼索隆无差 (74% vs 91% 在6周内达到≤3个水泡).
- 非劣势差额的上限 (26.1%) 处于预定义的37%门之内.
- 52周后,多西环林组发生的严重,危及生命或致命的不良事件显著减少 (18% vs 36%).
结论:
- 开始用多西环治疗是口服皮质类固醇的可行替代方案,以获得短期的疗效.
- 与口服普得尼索隆相比,多西环素在长期内显著改善了安全性.
- 这表明多西环素可能是首选的第一线治疗方法,平衡有效性和安全性.
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