Zhu Qin, Tang Guang-Yong, Hua Zhi-Juan, Xue Li-Ping, Zhou Yuan, Zhang Jie-Ying, Zhu Ying-Ting, Zhang Xiao-Fan
Department of Pediatric Ophthalmology, Affiliated Hospital of Yunnan University, Kunming 650021, Yunnan Province, China.
Department of Ophthalmology, People's Hospital of Xundian County, Kunming 655200, Yunnan Province, China.
Int J Ophthalmol. 2023 Jun 18;16(6):939-946. doi: 10.18240/ijo.2023.06.17. eCollection 2023.
To evaluate the effect of 0.05% atropine on the control of myopia for 2y (phase I) and on spherical equivalent refraction (SER) progression for 1y (phase II) after its withdrawal in Chinese myopic children.
Totally 142 children with myopia were randomly assigned to the 0.05% atropine group or to the placebo group. In phase I, children received 1 treatment for each eye daily. In phase II, the patients received no treatment. Axial length (AL), SER, intraocular pressure (IOP) and atropine-related side effects were assessed at 6 months' intervals.
During phase I, the mean change of SER was -0.46±0.30 D in the atropine group, compared to -1.72±1.12 D in the placebo group (<0.001). The mean change of AL in the atropine group (0.26±0.30 mm) was significantly shorter than that in the placebo group (0.76±0.62 mm, =0.002). In addition, in phase II (12mo after the withdrawal of atropine), there was no significant difference in AL change from the atropine group, when compared with that from the placebo group (0.31±0.25 mm 0.28±0.26 mm, >0.05). Furthermore, the change in SER from the atropine group was 0.50±0.41 D, which was significantly lower than 0.72±0.60 D from placebo group, (<0.05). Finally, there were no statistically significant differences in IOP between the treatment and control groups at any stages (all >0.05).
The use of 0.05% atropine for two consecutive years may effectively control elongation of AL and thus progression of myopia, without significant SER progression 1y after atropine withdrawal. Therefore, treatment with 0.05% atropine daily for 2y is effective and safe.
评估0.05%阿托品对中国近视儿童两年(第一阶段)近视控制及停药后一年(第二阶段)等效球镜度(SER)进展的影响。
142例近视儿童被随机分为0.05%阿托品组或安慰剂组。在第一阶段,儿童每天对每只眼睛进行1次治疗。在第二阶段,患者不接受治疗。每隔6个月评估眼轴长度(AL)、SER、眼压(IOP)及与阿托品相关的副作用。
在第一阶段,阿托品组SER的平均变化为-0.46±0.30 D,而安慰剂组为-1.72±1.12 D(<0.001)。阿托品组AL的平均变化(0.26±0.30 mm)明显短于安慰剂组(0.76±0.62 mm,P = 0.002)。此外,在第二阶段(停用阿托品后12个月),阿托品组与安慰剂组的AL变化相比无显著差异(0.31±0.25 mm对0.28±0.26 mm,P>0.05)。此外,阿托品组SER的变化为0.50±0.41 D,明显低于安慰剂组的0.72±0.60 D(P<0.05)。最后,治疗组和对照组在任何阶段的眼压均无统计学显著差异(均P>0.05)。
连续两年使用0.05%阿托品可有效控制AL延长,从而控制近视进展,且停药后一年SER无明显进展。因此,每天使用0.05%阿托品治疗两年是有效且安全的。