拉坦诺普罗斯特用于开角玻璃眼 (UKGTS):一个随机,多中心,安慰剂对照试验
David F Garway-Heath1, David P Crabb2, Catey Bunce1
1National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.
Lancet (London, England)
|December 24, 2014
概括
与安慰剂相比,拉塔诺普罗斯特眼药在开放角格劳科马患者的视野中显著保留视野. 这项首次安慰剂对照试验证明了药物的有效性.
科学领域:
- 眼科医生 眼科 眼科
- 临床试验 临床试验
- 青光眼研究研究研究
背景情况:
- 开角格劳科马治疗的目的是通过降低眼内压力来预防视力损失.
- 之前的试验缺乏安慰剂对照,并且有更长的观察期.
- 这项研究解决了对维护视觉功能的安慰剂对照试验的需求.
研究的目的:
- 评估接受拉坦诺普罗斯特与安慰剂的开角绿眼病患者的视野保护.
- 在随机的,安慰剂控制的环境中评估拉坦诺普罗斯特在预防视力丧失方面的疗效.
主要方法:
- 一个随机的,三重掩盖的,安慰剂控制的试验,涉及516名新诊断的开角玻璃眼患者.
- 参与者被分配给每天接受一次拉坦诺普罗斯特0.005%眼滴或安慰剂.
- 主要结局是24个月内视野恶化的时间.
主要成果:
- 在24个月后,拉坦诺普罗斯特组的平均眼内压力降低为3.8 mm Hg,而安慰剂组的0.9 mm Hg.
- 在拉坦诺普罗斯特组中,视野保存时间明显长 (调整后的危险比为0.44,p=0.0003).
- 没有严重的不良事件被归因于研究药物.
结论:
- 这是第一个随机的安慰剂对照试验,证明在开角玻璃眼中用眼内压力降压药物保护视野.
- 拉塔诺普罗斯特有效地保护视觉功能,支持其用于管理开角玻璃眼的使用.
- 研究设计允许在相对较短的观察期内评估显著差异.
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