香港中文大学Chi Pui Pang团队研究了低浓度阿托品滴眼液与安慰剂对儿童近视发生率的影响。该项研究成果发表在2023年2月14日出版的《美国医学会杂志》上。

早发近视与以后的高度近视有关，近视一旦发展是不可逆的。

为了评价0.05%和0.01%浓度的低浓度阿托品滴眼液对延迟近视发作的疗效，研究组在香港中文大学眼科中心进行了一项随机、安慰剂对照、双盲试验，招募了474名年龄在4至9岁之间的非近视儿童，他们的睫状肌麻痹球形当量在+1.00 D至0.00 D之间，散光小于-1.00 D。第一位招募的参与者于2017年7月11日开始治疗，最后一位参与者于2020年6月4日招募，最后一次后续随访的日期是2022年6月4日。

参与者被随机分配到0.05%阿托品组（n = 160）、0.01%阿托品组（n = 159）和安慰剂组（n = 155），并在两年内每晚使用一次眼药水。主要结局是2年累积近视发病率（任意眼的睫状肌麻痹球形近视当量至少为-0.50 D）和快速近视转移的参与者百分比（球形近视当量至少为1.00 D）。

474例随机患者（平均年龄6.8岁；女性占50%）中有353例（74.5%）完成试验。0.05%阿托品组、0.01%阿托品组和安慰剂组的2年累计近视发生率分别为28.4%、45.9%和53.0%，参与者2年近视快速转移的百分比分别为25.0%、45.1%和53.9%。与安慰剂组相比，0.05%阿托品组2年累积近视发生率（差异为24.6%）和快速近视转移患者百分比（差异为28.9%）显著降低。

与0.01%阿托品组相比，0.05%阿托品组2年累积近视发生率（差异为17.5%）和快速近视转移患者百分比（差异为20.1%）显著降低。0.01%阿托品组与安慰剂组在2年累积近视发生率或快速近视转移患者百分比方面无显著差异。畏光是最常见的不良事件，0.05%阿托品组第二年报告畏光的发生率为12.9%，0.01%阿托品组为18.9%，安慰剂组为12.2%。

研究结果表明，在4至9岁无近视的儿童中，与安慰剂相比，夜间使用0.05%阿托品滴眼液可显著降低近视发生率，并降低2年后快速近视转移的参与者百分比。0.01%阿托品与安慰剂比较差异无统计学意义。需要进一步的研究来重复这一发现，以了解这是否代表延迟或预防近视，并评估长期安全性。

附：英文原文

Title: Effect of Low-Concentration Atropine Eyedrops vs Placebo on Myopia Incidence in Children: The LAMP2 Randomized Clinical Trial

Author: Jason C. Yam, Xiu Juan Zhang, Yuzhou Zhang, Benjamin H. K. Yip, Fangyao Tang, Emily S. Wong, Christine H. T. Bui, Ka Wai Kam, Mandy P. H. Ng, Simon T. Ko, Wilson W.K. Yip, Alvin L. Young, Clement C. Tham, Li Jia Chen, Chi Pui Pang

Issue&Volume: 2023/02/14

Abstract:

Importance  Early onset of myopia is associated with high myopia later in life, and myopia is irreversible once developed.

Objective  To evaluate the efficacy of low-concentration atropine eyedrops at 0.05% and 0.01% concentration for delaying the onset of myopia.

Design, Setting, and Participants  This randomized, placebo-controlled, double-masked trial conducted at the Chinese University of Hong Kong Eye Centre enrolled 474 nonmyopic children aged 4 through 9 years with cycloplegic spherical equivalent between +1.00 D to 0.00 D and astigmatism less than 1.00 D. The first recruited participant started treatment on July 11, 2017, and the last participant was enrolled on June 4, 2020; the date of the final follow-up session was June 4, 2022.

Interventions  Participants were assigned at random to the 0.05% atropine (n=160), 0.01% atropine (n=159), and placebo (n=155) groups and had eyedrops applied once nightly in both eyes over 2 years.

Main Outcomes and Measures  The primary outcomes were the 2-year cumulative incidence rate of myopia (cycloplegic spherical equivalent of at least 0.50 D in either eye) and the percentage of participants with fast myopic shift (spherical equivalent myopic shift of at least 1.00 D).

Results  Of the 474 randomized patients (mean age, 6.8 years; 50% female), 353 (74.5%) completed the trial. The 2-year cumulative incidence of myopia in the 0.05% atropine, 0.01% atropine, and placebo groups were 28.4% (33/116), 45.9% (56/122), and 53.0% (61/115), respectively, and the percentages of participants with fast myopic shift at 2 years were 25.0%, 45.1%, and 53.9%. Compared with the placebo group, the 0.05% atropine group had significantly lower 2-year cumulative myopia incidence (difference, 24.6% [95% CI, 12.0%-36.4%]) and percentage of patients with fast myopic shift (difference, 28.9% [95% CI, 16.5%-40.5%]). Compared with the 0.01% atropine group, the 0.05% atropine group had significantly lower 2-year cumulative myopia incidence (difference, 17.5% [95% CI, 5.2%-29.2%]) and percentage of patients with fast myopic shift (difference, 20.1% [95% CI, 8.0%-31.6%]). The 0.01% atropine and placebo groups were not significantly different in 2-year cumulative myopia incidence or percentage of patients with fast myopic shift. Photophobia was the most common adverse event and was reported by 12.9% of participants in the 0.05% atropine group, 18.9% in the 0.01% atropine group, and 12.2% in the placebo group in the second year.

Conclusions and Relevance  Among children aged 4 to 9 years without myopia, nightly use of 0.05% atropine eyedrops compared with placebo resulted in a significantly lower incidence of myopia and lower percentage of participants with fast myopic shift at 2 years. There was no significant difference between 0.01% atropine and placebo. Further research is needed to replicate the findings, to understand whether this represents a delay or prevention of myopia, and to assess longer-term safety.

DOI: 10.1001/jama.2022.24162

Source: https://jamanetwork.com/journals/jama/article-abstract/2801319