不同年龄近视儿童使用0.01%阿托品滴眼液的有效性观察

Efficacy of 0.01% atropine in myopic children of different ages

摘要:

目的：评价0.01%阿托品滴眼液控制不同年龄儿童近视进展的有效性。方法： 随机、双盲、安慰剂平行对照、单中心临床研究。纳入2019-05/2020-05就诊于本院的年龄6～13周岁，近视球镜度数-0.5～-6.00D，散光度数≤2.0D的近视儿童295例，以2：1的比例随机分配到试验组(197例)和对照组(98例)，试验组和对照组按年龄又分为6～8岁(40例/26例)、9～10岁(84例/34例)及11～13岁(73例/38例)三个亚组，试验组每晚睡前点0.01%阿托品滴眼液，对照组每晚睡前点安慰剂。比较两组患者治疗前、治疗2wk，3、6、9及12mo各指标变化情况。治疗2wk仅行眼压、调节幅度、最佳矫正远/近视力、瞳孔直径及泪膜检查； 治疗前，治疗6及12mo行睫状肌麻痹验光。结果：治疗12mo后，试验组等效屈光度及眼轴变化分别为-0.37±0.69D及0.29±0.24mm，对照组为-0.59±0.65D及0.37±0.23mm(P=0.008、0.006)。两组间等效屈光度和眼轴变化比较6～8岁无差异(t=0.054，P=0.957； t=-0.623，P=0.536)； 9～10岁有差异(t=2.056，P=0.042； t=-2.057，P=0.042)； 11～13岁有差异(t=2.33，P=0.022； t=-2.424，P=0.017)。试验组治疗后瞳孔轻度散大、调节幅度降低，治疗12mo后两组平均瞳孔直径分别为3.94±0.79和3.16±0.48mm(P<0.001)，两组间其他参数及不良事件无差异。结论：使用0.01%硫酸阿托品滴眼液有助于控制儿童近视进展，且耐受性良好，但6～8岁的低龄儿童，使用0.01%阿托品滴眼液控制近视效果不佳，可以尝试增加阿托品使用浓度。

Abstract:

AIM: To valuate the efficacy of 0.01% atropine for controlling myopia in children of different ages.METHOD: A randomized, double-blind, placebo control and single-center study was conducted. A total of 295 myopic children, aged 6～13 years, with myopia of -0.5D～-6.00D and astigmatism ≤2.0D, who admitted to our hospital from May 2019 to May 2020 were randomly assigned to experimental group(197 cases)and control group(98 cases)in a 2:1 ratio. Two groups were further divided into three subgroups according to age, 6～8 years old group(40/26 cases), 9～10 years group(84/34 cases), and 11～13 years group(73/38 cases). 0.01% atropine was administrated in the experimental group and placebo was administrated in the control group once before sleep. The changes of parameters were compared before and at 2wk, 3, 6, 9 and 12mo after treatment. Intraocular pressure, accommodation amplitude, best corrected distance and near visual acuity, pupil diameter and tear film were tested at 2wk. Cycloplegic refraction was assessed before treatment, and at 6 and 12mo after treatment.RESULTS: The spherical equivalent and axial length progression at 12mo after administration was -0.37±0.69D and 0.29±0.24mm in the experimental group, and -0.59±0.65D and 0.37±0.23mm in the control group(P=0.008, 0.006). In 6～8 years group, spherical equivalent and axial length progression between experimental and control group were not statistically significant(t=0.054, P=0.957; t=-0.623, P=0.536). In 9～10 years group, spherical equivalent and axial length progression between groups were statistically significant(t=2.056, P=0.042; t=-2.057 P=0.042). In 11～13 years group, spherical equivalent and axial length progression between groups were statistically significant(t=2.33, P=0.022; t=-2.424, P=0.017). The pupil was slightly dilated and the accommodation amplitude was decreased in experimental group, and the mean pupil diameter of the two groups was 3.94±0.79 and 3.16±0.48 mm respectively at 12mo after treatment(P<0.001). Other parameters and adverse event noted between groups were not statistically significant.CONCLUSIONS: 0.01% atropine is helpful to control the progression of myopia in children, which is well tolerated by adolescents. However, the effect of 0.01% atropine on the control of myopia for children aged 6～8 years is not enough. The findings suggest that increased concentration of atropine can be tried for 6～8 years old.