0.01%硫酸阿托品滴眼液降低儿童青少年近距离用眼引起的短暂性近视的有效性和安全性

Efficacy and Safety of 0.01%Sulfate Atropine on Reducing Nearwork-Induced Transient Myopia in Children and Adolescents

目的:评价0.01%硫酸阿托品滴眼液降低儿童青少年近距离用眼引起的短暂性近视(NITM)的有效性和安全性。方法:前瞻性队列研究。随机纳入2021年1—6月就诊于温州医科大学附属眼视光医院符合条件且自愿参加本研究的6~18岁近视儿童青少年144例(144眼)。采用计算机区组随机方法将受检者按1∶1的比例随机分为研究组和对照组,分别采用0.01%硫酸阿托品滴眼液和空白溶媒滴眼液每晚睡前双眼滴眼1次进行治疗。在治疗前和用药后1周、2周以及停药后2周测量并记录受检者的初始NITM值、屈光度、瞳孔大小、眼压、滴药后眼部耐受性评价等,并计算初始NITM值较基线的差值百分比,同时记录用药过程中的不良反应。初始NITM值较基线时降低≥60%者判定为有效,较基线时降低<60%者判定为无效。采用独立样本t检验、重复测量方差分析、协方差分析,卡方检验和Fisher确切概率法对数据进行分析。结果:最终纳入127例(127眼)受检者,年龄(9.3±1.9)岁,其中研究组62例(62眼),对照组65例(65眼)。对照组、研究组基线初始NITM值分别为(-0.43±0.15)D和(-0.41±0.13)D,组间差异无统计学意义(t=0.65,P=0.517)。用药1周后对照组治疗有效率为43.1%,研究组为58.1%,组间治疗有效率差异无统计学意义(χ^(2)=2.85,P=0.091);研究组的初始NITM值小于对照组,差异有统计学意义(t=2.44,P=0.016)。用药2周后,对照组治疗有效率为29.2%,研究组为77.4%,组间差异有统计学意义(χ^(2)=29.56,P<0.001);研究组的初始NITM值小于对照组,差异有统计学意义[(-0.04±0.20)D vs.(-0.33±0.29)D,t=6.52,P<0.001]。研究期间组间患者在眼压、裂隙灯显微镜检查指标、用药后不适症状、耐受性评分和心率、血压等指标差异均无统计学意义(P>0.05)。结论:0.01%硫酸阿托品滴眼液能有效降低儿童青少年NITM程度,并且安全性较好,可作为近视防控的临床治疗选择之一。

Objective:To evaluate the efficacy and safety of 0.01%sulfate atropine eyedrops for reducing the nearwork-induced transient myopia(NITM)in children and adolescents.Methods:A prospective cohort study was performed.One hundred and forty-four myopia children aged 6-18 years(144 eyes)from Eye Hospital,Wenzhou Medical University between January and June 2021 were included.Participants were randomly allocated(1:1)to intervention or control groups using a computerized block group randomization method.Participants in the intervention and control groups were treated with 0.01%sulfate atropine or soluble medium of atropine once a night at bedtime for both eyes,respectively.Initial NITM values,refractive error,pupil size,intraocular pressure(IOP),and ocular tolerance after the drops were evaluated and recorded before treatment,1 week after treatment,2 weeks after treatment,and 2 weeks after discontinuation of the drug.The percentage differences of the initial NITM value from baseline were also calculated and adverse reactions during the drug administration were recorded.A reduction of≥60%in the initial NITM value compared with the baseline was considered effective,while a reduction of<60%was considered ineffective.Independent samples t-test,repeated measures ANOVA,analysis of covariance,and Chi-square or Fisher's exact test were used to analyze.Results:A total of 127 subjects(127 eyes)were finally included in the analyses.The mean age of the included subjects was 9.3±1.9 years.There were 62 subjects(62 eyes)in the intervention group and 65 subjects(65 eyes)in the control group.The initial NITM value at baseline was-0.43±0.15 D in the control group and-0.41±0.13 D in the intervention group,respectively.There was no statistically significant difference between the two groups for the initial NITM values(t=0.65,P=0.517).The efficiency at 1 week of drug administration was 43.1%in the control group and 58.1%in the intervention group,with no statistically significant difference observed(χ2=2.85,P=0.091).However,at 1 week after treatment,the initial NITM value of the intervention group was significantly lower than the control group(t=2.44,P=0.016).At 2 weeks after treatment,the efficiency was 29.2%in the control group and 77.4%in the intervention group,showing a statistically significant difference(χ2=29.56,P<0.001).At 2 weeks after treatment,the initial NITM values in the intervention group were significantly lower than those in the control group(-0.04±0.20 D vs.-0.33±0.29 D,t=6.52,P<0.001).There were no statistically significant differences between the two groups in IOP,slit lamp examination index,discomfort symptoms after treatment,tolerance score,heart rate,and blood pressure(all P>0.05).Conclusion:0.01%sulfate atropine is effective in reducing NITM in children and adolescents,with great safety,and may be considered as a clinical treatment option for myopia control.