间断使用1%阿托品滴眼液控制儿童近视进展的临床研究

林小俊; 陈琴; 段文华; 朱勤; 胡敏

doi:10.16835/j.cnki.1000-9817.2021.02.005

间断使用1%阿托品滴眼液控制儿童近视进展的临床研究

doi: 10.16835/j.cnki.1000-9817.2021.02.005

林小俊¹,
陈琴¹,
段文华²,
朱勤^2, ,,
胡敏^2, ,

1.
南京医科大学第一附属医院眼科，江苏 210060
2.
云南省第二人民医院

基金项目:

国家自然科学基金项目 81560169

国家自然科学基金项目 81960176

详细信息

作者简介:
林小俊(1981-)，男，江苏如东人，硕士，副主任医师，主要研究方向为白内障、眼屈光

通讯作者:
朱勤, E-mail：zhuqin619@163.com

胡敏, E-mail：fudanhumin@sina.com

中图分类号: R 778.11 R 179
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- 被引次数: 0
出版历程
- 收稿日期: 2020-09-14
- 修回日期: 2020-12-18
- 网络出版日期: 2021-04-06
- 刊出日期: 2021-02-25

Clinical study of intermittent use of 1% atropine on retardation of myopia progression in Chinese school children

LIN Xiaojun¹,
CHEN Qin¹,
DUAN Wenhua²,
ZHU Qin^{2
, ,},
HU Min^{2
, ,}

1.
Department of Ophthalmologic, First Affiliated Hospital with Nanjing Medical University, Nanjing(210060), China

摘要

摘要: 目的评估长期间断局部使用1%阿托品滴眼液延缓儿童进展性近视的有效性和安全性，为儿童近视防控工作提供基础数据。方法选取2016年1月至2019年12月云南省第二人民医院儿童眼科门诊收治的8~14岁近视小学生共计570例，随机分为实验组(262名)和对照组(308名)。实验组患儿在常规佩戴单焦框架眼镜基础上，第1~24月(Ⅰ期，治疗期)用1%阿托品滴眼液点眼，2周1次，双眼交替；第25~36月(Ⅱ期，过渡期)用1%阿托品滴眼液点眼，3周1次，双眼交替；第37~48月(Ⅲ期，药物撤退期)停药观察。对照组患儿佩戴单焦框架眼镜。随访期内，每组儿童均在用药前、用药后每6月检查等效球镜度、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 Ⅰ期结束时，每年实验组(-0.27±0.81)D的近视进展明显小于对照组(-1.29±0.13)D，每年实验组(0.11±0.13)mm的眼轴增长也明显小于对照组(0.41±0.19)mm(P值均 < 0.05)。Ⅱ期末，每年实验组的平均近视进展为(-0.31±0.29)D，低于对照组(-0.80±0.66)D，实验组(0.14±0.09)mm的眼轴增长也明显小于对照组(0.39±0.14)mm(P值均 < 0.01)。停用阿托品滴眼液后(Ⅲ期)后，实验组未出现明显屈光回退现象。在整个随访期间，未发现与阿托品相关的严重不良事件。结论 1%阿托品滴眼液局部间断使用并逐渐减量后再停药，可在保证近视治疗有效性的同时减少阿托品副作用，避免停药后屈光回退，同时提高儿童依从性。
- 阿托品 /
- 近视 /
- 随机对照试验 /
- 儿童
Abstract: Objective To evaluate the long-term ef efficacy and safety of topical 1% atropine for retarding pregressive myopia. Methods A randomized controlled study evaluating atropine and placebo in 570 Chinese children aged 8~14 years recruited from pediatric ophthalmology in Yunnan Provincial the Second People's Hospital during Jan. 2015 to Dec. 2019. In experimental group, patients received drops every two weeks for 24 months, then every three weeks for 12 months, followed by no drops for 12 months. In control group, all children wear single focus frame glasses. Spherical equivalent, axial length, intraocular pressure and atropine-related side effects were examined at 6, 12, 24, 36 and 48 months for all children. Results At the end of stage Ⅰ, the myopia progression in the atropine treatment group (-0.27±0.81)D was significantly lower than that in the control group (-1.29±0.13)D, and the increase of axial length in the atropine group (0.11±0.13)mm was also significantly lower than that in the control group (0.41±0.19)mm (P < 0.05). At the end of stage Ⅱ, the average myopia progression in the atropine treatment group (-0.31±0.28)D was significantly lower than that in the control group (-0.80±0.66)D (P < 0.01). Similarly, the axial growth of the experimental group (0.14±0.09)mm was significantly lower than that of the control group (0.39±0.14)mm (P < 0.01). After the withdrawal of atropine eye drops (stage Ⅲ), there was no significant refractive regression in the experimental group. During the whole follow-up period, no serious adverse events related to atropine were found. Conclusion Local intermittent use of 1% atropine eye drops and the gradual reduction of atropine eye drops can ensure the effectiveness in the treatment of myopia, reducing the side effects of atropine, avoiding refractive regression after drug withdrawal, and improving children's compliance at the same time.
- Atropine /
- Myopia /
- Randomized controlled trial /
- Child

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表 1 各时间点屈光度和眼轴长度治疗组和对照组间比较(x ±s)

Table 1. Comparison of diopter and axial length at each time point between the treatment group and the control group(x ±s)

屈光度和眼轴长度	实验组 (n=262)	对照组 (n=308)	t值	P值
等效球镜度/D
治疗前	-3.82±0.44	-3.74±0.51	-2.01	0.05
治疗后6个月	-3.91±0.35	-4.15±0.89	4.35	< 0.01
治疗后12个月	-4.05±0.97	-4.79±0.82	9.74	< 0.01
治疗后18个月	-4.11±0.80	-5.21±0.88	15.50	< 0.01
治疗后24个月	-4.27±0.21	-5.68±1.03	23.46	< 0.01
治疗后30个月	-4.41±0.93	-6.12±0.73	24.11	< 0.01
治疗后36个月	-4.58±1.32	-6.59±1.10	19.54	< 0.01
治疗后48个月	-4.96±1.22	-7.28±1.26	22.23	< 0.01
每年近视进展/D
治疗前	-1.28±0.81	-1.29±0.13	0.20	0.84
治疗后6个月	-0.27±0.16	-1.01±0.49	24.98	< 0.01
治疗后12个月	-0.24±0.22	-0.98±0.90	13.95	< 0.01
治疗后18个月	-0.22±0.14	-0.91±0.61	19.26	< 0.01
治疗后24个月	-0.21±0.22	-0.89±0.23	35.89	< 0.01
治疗后30个月	-0.29±0.19	-0.82±0.14	37.34	< 0.01
治疗后36个月	-0.31±0.29	-0.80±0.66	11.76	< 0.01
治疗后48个月	-0.41±0.23	-0.75±0.64	8.69	< 0.01
轴向长度/mm
治疗前	24.93±0.21	24.91±0.18	1.21	0.23
治疗后6个月	25.00±0.18	25.13±0.12	-9.96	< 0.01
治疗后12个月	25.03±0.11	25.34±0.08	-37.88	< 0.01
治疗后18个月	25.10±0.15	25.57±0.14	-38.95	< 0.01
治疗后24个月	25.18±0.21	25.72±0.17	-33.35	< 0.01
治疗后30个月	25.26±0.18	25.98±0.13	-53.89	< 0.01
治疗后36个月	25.31±0.14	26.18±0.14	-73.94	< 0.01
治疗后48个月	25.48±0.29	26.59±0.20	-66.04	< 0.01
每年眼轴进展/mm
治疗前	0.41±0.27	0.42±0.26	-0.45	0.65
治疗后6个月	0.11±0.13	0.41±0.19	-22.26	< 0.01
治疗后12个月	0.12±0.10	0.40±0.06	-39.66	< 0.01
治疗后18个月	0.12±0.16	0.40±0.11	-23.92	< 0.01
治疗后24个月	0.12±0.10	0.39±0.19	-21.66	< 0.01
治疗后30个月	0.13±0.06	0.39±0.04	-59.75	< 0.01
治疗后36个月	0.14±0.09	0.39±0.14	-25.71	< 0.01
治疗后48个月	0.19±0.13	0.40±0.16	-17.28	< 0.01

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