目的比较质量分数0.01%和0.02%阿托品滴眼液控制青少年近视进展的效果和安全性。
方法采用随机双盲对照研究方法，纳入2016年6月至2017年6月在郑州大学第一附属医院就诊的6~12岁青少年近视患者280例280眼，等效球镜度(SE)为-1.25~-6.0 D。试验前受试者均配戴全矫单焦框架眼镜矫正屈光不正。采用随机数字表法将受试者分为0.01%阿托品组(142例142眼)和0.02%阿托品组(138例138眼)，受试者于睡前用相应质量分数阿托品滴眼液点眼1滴，均将右眼研究资料纳入分析。分别于用药后第1、4、8和12个月进行随访。采用电脑验光仪测定受试者用药前后SE以评估屈光度变化；采用IOLMaster测量受试者用药前后前房深度、角膜曲率和眼轴长度；采用问卷调查记录受试者用药后不适症状。
结果0.01%阿托品组23例失访，0.02%阿托品组21例失访，随访完成率分别为83.8%和84.8%。用药1年内，SE随用药时间的延长均逐渐增加，0.01%阿托品组和0.02%阿托品组用药1年SE分别进展(-0.47±0.32)D和(-0.38±0.35)D，差异有统计学意义( P＝0.040)，矫正影响SE增加量的混杂因素，如年龄、体质量指数和基线SE后，经重复测量数据的广义相加混合模型分析，2个组SE增加率分别为-0.039 D/月和-0.032 D/月，差异有统计学意义( P 交互作用＝0.041)。0.01%阿托品组和0.02%阿托品组的眼轴长度随用药时间的延长均逐渐增加，0.01%阿托品组和0.02%阿托品组用药1年眼轴长度分别增加(0.37±0.20)mm和(0.30±0.17)mm，差异有统计学意义( P＝0.004)，矫正影响眼轴长度增加量的混杂因素，如年龄、体质量指数、基线眼轴长度后，经重复测量数据的广义相加混合模型分析，2个组的眼轴长度增加率分别为0.031 mm/月和0.025 mm/月，差异有统计学意义( P 交互作用＝0.032)。用药1~4周内，0.01%阿托品组和0.02%阿托品组分别有26.9%(32/119)和28.2%(33/117)受试者出现畏光症状；用药后2~4周，0.01%阿托品组和0.02%阿托品组均有7例受试者出现视近模糊，分别占5.9%(7/119)和6.0%(7/117)；用药后1个月，0.01%阿托品组有1例出现局部药物变态反应，停药后症状消失。
结论青少年连续局部应用0.01%和0.02%阿托品滴眼液1年的局部不良反应发生率接近，0.02%阿托品滴眼液点眼对青少年近视进展的控制效果较0.01%阿托品好。
ObjectiveTo compare the clinical efficacy and safety of 0.01% and 0.02% atropine eye drops on myopia development in adolescents.
MethodsA randomized controlled double-blind study was carried out.Two hundred and eighty myopic adolescents (280 eyes) with spherical equivalent (SE) from -1.25 to -6.0 D were enrolled in The First Affiliated Hospital of Zhengzhou University from June 2016 to June 2017.All the subjects wore full-correction single vision spectacle lenses before topical administration of atropine eye drops.The subjects were randomly divided into 0.01% atropine group (142 eyes) and 0.02% atropine group (138 eyes) according to the random number table method.Atropine 0.01% or 0.02% eye drops was topically used in the test eye once per night according to grouping, and the related parameters of the right eyes were collected for data analysis.The subjects were followed up at the 1st, 4th, 8th and 12th month following administration.The SE was measured with an autorefractor to evaluate the refractive change.The anterior chamber depth, corneal curvature and axial length (AL) were measured with an IOLMaster.The adverse responses of atropine eye drops were investigated via a questionnaire.This study protocol adhered to the Declaration of Helsinki and was approved by an Ethics Committee of The First Affiliated Hospital of Zhengzhou University (No.2016-35). Written informed consent was obtained from subjects and their guardian prior to entering the cohort.
ResultsThe follow-up rate of 0.01% atropine group was 83.8%, and the follow-up rate of 0.02% atropine group was 84.8% at the end of following-up.SE and AL increased by (-0.47±0.32)D and (0.37±0.20)mm in 0.01% atropine group, and (-0.38±0.35)D and (0.30±0.17)mm in 0.02% atropine groups during the following-up, respectively, showing statistically significant differences between two groups ( P=0.040, 0.004). After adjusting age, body mass index and baseline SE, the analysis by generalized additive mixed model showed that the increase rate of SE was -0.039 D/month and -0.032 D/month in 0.01% and 0.02% atropine group, respectively ( P interaction=0.041). After adjusting age, body mass index and baseline AL, the analysis of mixed effect model showed that the increase rate of AL was 0.031 mm/month and 0.025 mm/month in 0.01% and 0.02% atropine group, respectively ( P interaction=0.032). In 0.01% and 0.02% atropine groups, 32 cases (26.9%) and 33 cases (28.2%) occurred photophobia from 1st to 4th week during administration, and 7 cases (5.9%) and 7 cases (6.0%) appeared near-vision blur from 2nd to 4th week.Allergic response occurred in 0.01% atropine group at 1 month of treatment, and the symptom disappeared after interruption of the medication for two days.
ConclusionsThe incidence of adverse resoponses of 0.01% and 0.02% atropine eye drops is similar.Atropine 0.02% eye drops is more effective in controlling myopia progression.
符爱存,荣军博,王卫群,等. 0.01%与0.02%阿托品滴眼液对青少年近视控制效果的随机对照研究[J]. 中华实验眼科杂志,2022,40(03)：253-259.
DOI:10.3760/cma.j.cn115989-20190112-00007版权归中华医学会所有。
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符爱存：研究选题和设计、实施研究、采集数据和分析论文撰写；荣军博：实施研究、采集数据、分析/解释数据、对文章的知识性内容进行修改；王卫群：参与酝酿和设计试验、文章进行修改；魏丽、赵兵新：研究参数测量、采集数据、对文章进行修改；张俊杰：研究选题和药物配制、对文章智力性内容进行修改和定稿；吕勇：研究设计和实施、实验数据审核和分析、文章智力性内容修改及定稿
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