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0.01%近视前预防近视的亚特罗平 (AMPP研究)
Meinan He1, Hanru Wang1, Bei Du1
1Tianjin Key Laboratory of Retinal Functions and Diseases, Tianjin Branch of National Clinical Research Centre for Ocular Disease, Eye Institute and School of Optometry, Tianjin Medical University Eye Hospital, Tianjin, China.
概括
低剂量阿特罗宾眼药有效减缓儿童近视的进展. 在12个月的时间里,每晚0.01%的阿特罗宾在12个月的时间里在前近视儿童中减少了53%的近视转移,没有显著的不良影响.
科学领域:
- 眼科医生 眼科 眼科
- 儿科医学 儿科医学
- 临床研究 临床研究
背景情况:
- 近视,或近视,是一个日益增长的全球儿童健康问题.
- 早期干预对于预防高近视和相关的眼部并发症至关重要.
- 近视前期代表了近视控制干预的关键窗口.
研究的目的:
- 评估0.01%的阿特罗宾眼滴在预防近视前期近视的5-12岁儿童近视进展方面的疗效.
- 为了评估在12个月的治疗期间使用0.01%的阿特罗宾眼滴的安全性,
主要方法:
- 一项随机对照试验 (ChiCTR2200055482) 涉及64名5至12岁的近视前儿童.
- 参与者被随机分配1:1接受0.01%的阿特罗宾或安慰剂眼滴,每晚服用12个月.
- 主要结局指标是12个月后循环的球体等价值 (SE) 的变化.
主要成果:
- 与安慰剂相比,0.01%的氨酸组显示SE的变化明显较小 (-0.23D vs. -0.49D,p=0.03),表明近视进展减少了53%.
- 轴长度 (AL) 延长在阿特罗平组减少了19%,尽管这种差异在统计学上并不显著 (p=0.13).
- 在阿特罗平组中观察到较大的瞳孔直径,但关键的安全参数,如适应幅度,膜稳定性和眼内压力在各组之间仍然可比.
结论:
- 每晚0.01%的氨酸眼滴在1年内有效延迟近视前儿童的近视转移,年龄为5-12岁.
- 治疗表明了良好的安全性,没有持续的不良事件.
- 虽然轴延长减少了,但可能需要进一步的研究来确认其统计学意义.
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