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 baselinePD 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 (Fgroup =2.168,P=0.013;Ftime =2.139,P=0.015;Finteraction =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 (Fgroup =18.346,P =0.034;Ftime =1.823,P =0.002;Fintercation =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.%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.
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