间断使用1%阿托品滴眼液控制儿童近视进展的临床研究

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

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。

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.