低剂量0.01%的阿特罗平眼药滴与用于近视控制的安慰剂:一项随机临床试验
Michael X Repka1, Katherine K Weise2, Danielle L Chandler3
1Wilmer Eye Institute, Baltimore, Maryland.
JAMA ophthalmology
|July 13, 2023
概括
在美国儿童中,低剂量氨酸眼药并没有减缓近视的进展. 这项研究发现,与安慰剂相比,折射误差或轴长度变化没有显著差异.
科学领域:
- 眼科医生 眼科 眼科
- 儿科医学 儿科医学
- 临床试验 临床试验
背景情况:
- 近视的进展是一个全球性的问题,低剂量氨酸在东亚儿童中显示出有前途.
- 对于不同儿童群体,需要有效的近视控制策略.
研究的目的:
- 评估0.01%的阿特罗宾眼药在减缓美国儿童近视进展方面的疗效.
- 为了比较阿特罗宾对折射误差和轴长度的影响与安慰剂.
主要方法:
- 一个随机的,双面罩的,安慰剂控制的试验,涉及187名年龄在5-12岁的儿童,近视程度低至中等.
- 参与者每天晚上接受0.01%的氨酸或安慰剂眼滴,持续24个月,随后进行6个月的观察期.
- 球体等效折射误差 (SER) 和轴长被蒙面检查员测量.
主要成果:
- 从基线到24个月的SER变化没有显著差异,在阿特罗平 (-0.82 D) 和安慰剂 (-0.80 D) 组之间 (差异 = -0.02 D).
- 24个月后轴长度变化没有显著差异 (阿特罗平:0.44毫米,安慰剂:0.45毫米;差异=-0.002毫米).
- 在30个月的随访中,无论是SER还是轴长度,结果仍然无意义.
结论:
- 每天晚上服用0.01%的阿特罗宾眼药并没有减缓近视的进展或轴延长在美国儿童中低到中度近视.
- 这些发现不支持在这个人群中使用0.01%的阿特罗宾来控制近视.
- 可能需要进一步的研究来探索不同的度或种群.
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