皮眼科解决方案可减少儿科患者近视的进展:随机,双盲多中心II期APPLE研究
Audrey Chia1, Cheryl Ngo2, Nozhat Choudry3
1Singapore National Eye Centre, Singapore, Singapore.
概括
低剂量阿特罗宾眼液的0.005%和0.01%有效地减缓了儿童近视的进展. 最低剂量 (0.0025%) 没有影响,但所有阿特罗宾配方均安全且耐受良好.
科学领域:
- 眼科医生 眼科 眼科
- 儿科医学 儿科医学
- 药理学 药理学是指药理学的学科.
背景情况:
- 近视或近视是儿童日益严重的公共卫生问题.
- 需要有效的干预措施来减缓近视的进展,并预防相关的眼睛健康并发症.
研究的目的:
- 为了评估低剂量氨酸在治疗儿科近视时的剂量反应关系.
- 与安慰剂相比,评估不同度 (0.0025%,0.005%,0.01%) 的阿特罗宾的安全性和有效性.
主要方法:
- 一个II期,随机,双面膜,安慰剂对照试验,涉及99名儿童 (6-11岁) 轻度至中度近视.
- 参与者在12个月内每天晚上在每只眼睛中接受一滴阿特罗宾或安慰剂.
- 主要结局是球体等价值 (SE) 的变化;次要结局包括轴长 (AL) 和视力敏度.
主要成果:
- 与安慰剂相比,Atropine 0.005%和0.01%显著降低了近视进展 (SE变化分别为-0.33 D和-0.39 D) (-0.55 D).
- 观察到0.005% (-0.09毫米) 和0.01% (-0.10毫米) 的热素与安慰剂相比,轴长度延长的显著差异.
- 没有注意到近视敏度的显著变化;常见的副作用包括轻微的和视力模糊,对瞳孔大小或住宿的影响最小.
结论:
- 低剂量的0.005%和0.01%的阿特罗宾在减缓儿童近视进展方面表现出有效性.
- 在这项研究中,0.0025%的阿特罗宾剂量没有有效.
- 所有测试的阿特罗宾度被发现是安全的,并被儿科参与者很好地容忍.
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