0.05%阿托品滴眼液对小学生近视控制的有效性和安全性

朱勤; 周圆; 张晓帆; 张洁莹; 胡敏

doi:10.16835/j.cnki.1000-9817.2021.02.003

0.05%阿托品滴眼液对小学生近视控制的有效性和安全性

doi: 10.16835/j.cnki.1000-9817.2021.02.003

云南省第二人民医院眼科，昆明 650021

基金项目:

国家自然科学基金资助项目 81560168

云南省第二人民医院院内课题 ynkt2019005

详细信息

作者简介:
朱勤(1985-)，女，云南人，硕士，主治医师，主要研究方向为儿童眼病及眼视光

通讯作者:
胡敏, E-mail：fudanhumin@sina.com

中图分类号: R 179 R 778.11
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- 被引次数: 0
出版历程
- 收稿日期: 2020-05-24
- 修回日期: 2020-07-13
- 网络出版日期: 2021-04-06
- 刊出日期: 2021-02-25

Efficacy and safety of 0.05% atropine eye drops for retarding myopia progression in Chinese primary school students

Department of Ophthalmology, Second People's Hospital of Yunnan Province, Kunming(650021), China

摘要

摘要: 目的评估0.05%阿托品滴眼液对小学生近视控制的有效性和安全性，为制定近视的相关防控措施提供参考依据。方法选取2016年1月至2019年1月云南省第二人民医院儿童眼科门诊收治的8~12岁近视小学生共计188例，随机均分为实验组(93例)和对照组(95例)。在第1~24个月，阿托品组儿童每晚睡前双眼滴1次0.05%阿托品滴眼液。对照组儿童每晚睡前双眼滴1次0.3%玻璃酸钠滴眼液。第25~36个月，实验组及对照组儿童均停止用药。在随访期内，每组儿童均在用药前、用药后每6个月检查其等效球镜度、眼轴长度、眼压变化，问卷调查药物相关不良反应发生率。结果在用药期间，实验组等效球镜度年进展值[(-0.35±0.21)D/年]及眼轴长度年进展值[(0.11±0.07)mm/年]明显少于对照组[(-0.83±0.26)D/年，(0.37±0.22)mm/年](t值分别为1.29，-1.37，P值均 < 0.05)。停用阿托品滴眼液后，实验组的等效球镜进展值[(-0.40±0.29)D/年]及眼轴长度进展值[(0.10±0.04)mm/年]明显低于对照组[(0.73±0.40)D/年，(0.30±0.11)mm/年]。在整个随访期间，没有发现与阿托品相关的严重不良事件。停用阿托品后，瞳孔大小、近视力和调节幅度逐渐恢复到治疗前水平。结论局部使用0.05%阿托品滴眼液可有效延缓青少年近视进展，且不导致眼压异常及严重不良反应，具有较好的应用安全性。
- 阿托品 /
- 近视 /
- 随机对照试验 /
- 学生
Abstract: Objective To evaluate the efficacy and safety of 0.05% atropine eye drops for retarding myopia progression and ocular axial elongation in school children, and to provide a reference for the relevant prevention and control measures of myopia. Methods A total of 188 children with myopia were randomly assigned to the experimental group(93) or to the control group(95). During the phase (first 24 months) I, children received treatment in each eye once a day. During the phase II (from 25th to the 36th month), no treatment was given. Standardized eye examinations including spherical equivalent(SE), axial length(AL), intraocular pressure(IOP) and potential atropine-related side effect assessment were performed every 6 months. Results In phase I, the annual progression rates of equivalent spherical degree [(-0.35±0.21)D/year] and axial length [(0.11±0.07)mm/year] in the experimental group were significantly lower than those in the control group [(-0.83±0.26)D/year and (0.37±0.22)mm/year] (P < 0.05). After withdrawal of atropine eye drops (phase II), the equivalent spherical degree progression rate [(-0.40±0.29)D/year] and axial length progression rate [(0.10±0.04)mm/year] in the experimental group were significantly lower than those in the control group [(0.73±0.40)D/year and (0.30±0.11)mm/year]. No serious adverse events associated with atropine were found during the follow-up period. After the withdrawal of atropine, the pupil size, near visual acuity and adjustment gradually returned to the pre-treatment level. Conclusion 0.05% atropine eye drops may not only maintain the efficacy and reduce potential side effects of atropine but also significantly increase the compliance of children, 0.05% atropine is a safe and effective treatment for retarding myopic progression in moderate myopia.
- Atropine /
- Myopia /
- Randomized controlled trial /
- Students

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表 1 实验组及对照组小学生治疗前后等效球镜值比较(x ±s，D/年)

Table 1. Comparison of spherical equivalent over time in treatment group and control group (x ±s, D/year)

组别	眼数	治疗前	治疗后						年均增长值
组别	眼数	治疗前	6个月	12个月	18个月	24个月	30个月	36个月	年均增长值
实验组	186	-3.29±0.22	-3.39±0.29	-3.52±0.71	-3.70±0.61	-3.83±1.01	-4.08±0.95	-4.23±1.03	-0.31±0.21
对照组	190	-3.32±0.52	-3.73±0.81	-4.18±0.66	-4.64±0.72	-5.09±1.16	-5.45±1.16	-5.82±1.16	-0.83±0.26
t值		1.01	0.29	3.87	4.52	4.29	5.00	5.02	1.29
P值		0.31	0.03	0.02	0.02	0.01	0.01	0.01	0.01

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表 2 治疗前后实验组及对照组小学生眼轴长度值比较(x ±s，mm/年)

Table 2. Comparison of changes in axial length over time in treatment group and control group (x ±s, mm/year)

组别	眼数	治疗前	治疗后						年均增长值
组别	眼数	治疗前	6个月	12个月	18个月	24个月	30个月	36个月	年均增长值
治疗组	186	23.75±0.22	23.80±0.19	23.87±0.12	23.91±0.17	23.99±0.23	24.05±0.13	24.09±0.23	0.11±0.07
对照组	190	23.68±0.19	23.81±0.11	24.19±0.08	24.31±0.15	24.50±0.18	24.69±0.16	24.80±0.21	0.37±0.22
t值		1.27	-0.98	-1.16	-2.94	-3.65	-3.50	-5.29	-1.37
P值		0.29	0.16	0.03	0.02	0.01	0.01	0.00	0.00

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