钟梅; 吕勇; 符爱存; 张俊杰; 魏丽; 赵兵新; 王卫群

doi:10.3760/cma.j.issn.2095-0160.2019.07.009

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• 临床研究 •

质量分数0.01%和0.02%阿托品滴眼液对近视儿童瞳孔直径和调节幅度影响的一年随机、双盲、临床对照试验

中华实验眼科杂志, 2019,37(7) : 540-545. DOI: 10.3760/cma.j.issn.2095-0160.2019.07.009

摘要

目的

评价质量分数0.01%和0.02%阿托品滴眼液对近视儿童瞳孔直径和调节幅度的影响，分析瞳孔直径和调节幅度变化的相关因素。

方法

采用前瞻性随机对照研究设计，纳入2016年6—10月在郑州大学第一附属医院就诊并完成1年随访的近视儿童193例193眼，均取右眼进行分析。按照随机数字表法分为3个组，0.01%阿托品组72例，0.02%阿托品组74例，均配戴全矫单光框架眼镜，同时睡前双眼0.01%或0.02%阿托品滴眼液各1滴；对照组80例，仅戴全矫单光框架眼镜。给药前和给药后4、8和12个月测量受试者瞳孔直径和调节幅度。

结果

各组患者基线瞳孔直径和调节幅度比较，差异均无统计学意义(F＝9.321，P＝0.820；F＝13.209，P＝0.220)。给药后12个月，0.01%阿托品组、0.02%阿托品组和对照组瞳孔直径分别增大0.75、0.84和0.02 mm。各组不同时间点瞳孔直径比较，差异均有统计学意义(F_分组＝2.168，P＝0.013；F_时间＝2.139，P＝0.015；F_交互作用＝2.148，P＝0.001)。0.01%阿托品组和0.02%阿托品组用药后4、8和12个月瞳孔直径均较用药前增大，差异均有统计学意义(均P<0.001)。对照组瞳孔直径稳定。用药12个月后，0.01%阿托品组、0.02%阿托品组和对照组调节幅度分别降低1.25、1.12和0.28 D。各组不同时间点调节幅度比较，差异均有统计学意义(F_分组＝18.346，P＝0.034；F_时间＝1.823，P＝0.002；F_交互作用＝3.239，P＝0.023)。0.01%阿托品组和0.02%阿托品组用药后4、8和12个月调节幅度均明显低于用药前，差异均有统计学意义(均P<0.05)，对照组调节幅度稳定。经线性回归分析，阿托品组的瞳孔直径变化量与年龄、基线瞳孔直径和眼轴长度增加量呈线性相关(β＝0.06，P＝0.019；β＝－0.44，P<0.001；β＝－0.37，P＝0.045)。阿托品组的调节幅度变化量与基线调节幅度呈线性相关(β＝－0.71，P<0.001)。

结论

0.01%和0.02%阿托品滴眼液对近视儿童的瞳孔直径和调节幅度影响无明显差异。

引用本文: 钟梅, 吕勇, 符爱存, 等. 质量分数0.01%和0.02%阿托品滴眼液对近视儿童瞳孔直径和调节幅度影响的一年随机、双盲、临床对照试验 [J] . 中华实验眼科杂志, 2019, 37(7) : 540-545. DOI: 10.3760/cma.j.issn.2095-0160.2019.07.009.

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未经授权，不得转载、摘编本刊文章，不得使用本刊的版式设计。

除非特别声明，本刊刊出的所有文章不代表中华医学会和本刊编委会的观点。

近视和高度近视患病率的日益增加对经济和社会产生显著影响。目前，有多种方法用于控制儿童近视的进展，如角膜塑形镜、周边离焦设计的隐形眼镜、增加户外活动时间、低浓度阿托品滴眼液等^{[1,2,3,4,5,6,7,8]}。研究显示，应用低浓度阿托品滴眼液控制儿童近视发展是安全、有效的^[5,6,7]。阿托品滴眼液的浓度越高，不良反应越大，控制近视发展的效果越好，但停药后反弹更明显^[6,7]。理想的阿托品浓度应在有效性和安全性间取得平衡。应用低浓度阿托品滴眼液的主要不适症状是畏光、眩光和视近模糊^{[5,8,9,10,11,12,13,14]}。由于各研究中阿托品的浓度、种族和观察时间等不同，畏光眩光和视近模糊的比例有较大的差异。研究发现，质量分数0.01%和0.02%阿托品不适症状比例较低，对瞳孔直径和调节幅度影响一致，但质量分数0.05%阿托品的不适症状比例较高^[12]。一项前瞻性随机双盲研究发现，0.05%阿托品控制近视的效果最佳，0.01%阿托品不良反应最小^[14]。畏光、眩光可能与用药后瞳孔扩大和瞳孔对光反射变慢，视近模糊与调节幅度下降有关^[12]。本课题组前期研究发现，中国大陆近视儿童应用0.01%硫酸阿托品滴眼液4个月后，最佳矫正远、近视力和眼压均未变化；瞳孔直径轻度散大，调节幅度轻度下降，10%的受试儿童用药初期出现畏光等不适，但对学习和生活无影响^[15]。本研究中对应用0.01%和0.02%阿托品滴眼液1年的近视儿童进行随访，对瞳孔直径和调节幅度的变化情况以及二者变化量的相关因素进行总结，为低浓度阿托品滴眼液控制儿童近视发展提供参考依据。

贡献者信息

钟梅

郑州大学第一附属医院眼科　450000

吕勇

郑州大学第一附属医院眼科　450000

符爱存

郑州大学第一附属医院眼科　450000

张俊杰

河南省眼科研究所　河南省立眼科医院，郑州　450003

魏丽

郑州大学第一附属医院眼科　450000

赵兵新

郑州大学第一附属医院眼科　450000

王卫群

郑州大学第一附属医院眼科　450000

通信作者

符爱存

郑州大学第一附属医院眼科　450000

Email：109848196@qq.com

关键词

儿童; 近视; 阿托品/低浓度; 调节幅度; 瞳孔直径; 随机、双盲、临床对照试验;

基金项目

河南省卫健委医学科技攻关项目（201602073）

河南省科技厅重点研发与推广专项项目（201801591）

河南省教育厅高等学校重点科研项目（19A320066）

作者声明

临床试验注册：中国临床试验注册中心，ChiCTR-IPD-16008844

利益冲突

利益冲突　所有作者均声明不存在利益冲突

历史

出版日期：2019-07-10

收稿日期：2019-01-04

修回日期：2019-05-20

本文编辑

杜娟

Clinical Science

Effects of 0.01% and 0.02% atropine eye drops on pupil diameter and accommodation amplitude in myopic children: one-year randomized, double blind, controlled trail

Mei Zhong, Yong Lyu, Aicun Fu, Junjie Zhang, Li Wei, Bingxin Zhao, Weiqun Wang

Published 2019-07-10

Cite as Chin J Exp Ophthalmol, 2019, 37(7): 540-545. DOI: 10.3760/cma.j.issn.2095-0160.2019.07.009

Abstract

Objective

To evaluate the effects of 0.0% and 0.02% atropine on pupil diameter (PD) and accommodation amplitude (AMP) in myopic children and analyze its relation factors.

Methods

A prospective randomized controlled trial design was adopted.One hundred and ninety-three myopia children were included from June to October, 2016 in the First Affiliated Hospital of Zhengzhou University, all the children completed one-year follow-up.All the children were divided into three groups randomly, with 72, 74 and 80 myopic children in 0.01% atropine group, 0.02% atropine group and control group, respectively.The myopic children in 0.01% atropine group and 0.02% atropine group wore single-vision spectacle lenses and were treated with 0.01% and 0.02% atropine eye drops nightly, respectively.The myopic children in the control group wore spectacle lenses only.The PD and AMP were measured at baseline, and 4, 8 and 12 months after treatment.

Results

There were no significant difference of baseline PD and AMP among the three groups (F=9.321, P=0.820; F=13.209, P=0.220). Compared with basline, after 12 months, the PD increased by 0.75, 0.84 and 0.02 mm in 0.01% atropine group, 0.02% atropine group and control group, respectively.There were statistically significant differences of PD among three groups at different time points (F_group=2.168, P=0.013; F_time=2.139, P=0.015; F_interaction=2.148, P=0.001). Compared with baseline, the PD of 0.01% atropine group and 0.02% atropine group were increased 4, 8 and 12 months after treatment, and the difference was statistically significant (all at P<0.001). The PD was stable in control group.After 12 months, the AMP were reduced by 1.25, 1.12 and 0.28 D in 0.01% atropine group, 0.02% atropine group and control group, respectively.There were statistically significant differences of AMP among the three groups at the different time points (F_group=18.346, P=0.034; F_time=1.823, P=0.002; F_intreatcion=3.239, P=0.023). Compared with baseline, the AMP of 0.01% atropine group and 0.02% atropine group were increased 4, 8 and 12 months after treatment, and the differences were statistically significant (all at P<0.05). The AMP remained stable in control group.The change of PD in 0.01% atropine group and 0.02% atropine group was correlated with age, baseline PD and baseline eye axis length, respectively (β=0.060, P=0.019; β=-0.440, P<0.001; β=-0.37, P=0.045). The change in AMP of the atropine group was significantly correlated with the baseline adjustment range (β=-0.71, P<0.001).

Conclusions

0.01% and 0.02% atropine show similar effects on pupil diameter and accommodation amplitude after 12 months of treatment in myopic children.

Key words:

Children; Myopia; Atropine, low doses; Pupil diameter; Accommodation amplitude; Randomized double blind controlled trail

Contributor Information

Mei Zhong