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PURPOSE

(1) To compare the efficacy of continued and stopping treatment for 0.05%, 0.025%, and 0.01% atropine during the third year. (2) To evaluate the efficacy of continued treatment over 3 years. (3) To investigate the rebound phenomenon and its determinants after cessation of treatment.

DESIGN

A randomized, double-masked extended trial.

PARTICIPANTS

A total of 350 of 438 children aged 4 to 12 years originally recruited into the Low-Concentration Atropine for Myopia Progression (LAMP) study.

METHODS

At the beginning of the third year, children in each group were randomized at a 1:1 ratio to continued treatment and washout subgroups. Cycloplegic spherical equivalent (SE) refraction and axial length (AL) were measured at 4-month intervals.

MAIN OUTCOME MEASURES

Changes in SE and AL between groups.

RESULTS

A total of 326 children completed 3 years of follow-up. During the third year, SE progression and AL elongation were faster in the washout subgroups than in the continued treatment groups across all concentrations: -0.68 ± 0.49 diopters (D) versus -0.28 ± 0.42 D (P < 0.001) and 0.33 ± 0.17 mm versus 0.17 ± 0.14 mm (P < 0.001) for the 0.05%; -0.57 ± 0.38 D versus -0.35 ± 0.37 D (P = 0.004) and 0.29 ± 0.14 mm versus 0.20 ± 0.15 mm (P = 0.001) for the 0.025%; -0.56 ± 0.40 D versus -0.38 ± 0.49 D (P = 0.04) and 0.29 ± 0.15 mm versus 0.24 ± 0.18 mm (P = 0.13) for the 0.01%. Over the 3-year period, SE progressions were -0.73 ± 1.04 D, -1.31 ± 0.92 D, and -1.60 ± 1.32 D (P = 0.001) for the 0.05%, 0.025%, and 0.01% groups in the continued treatment subgroups, respectively, and -1.15 ± 1.13 D, -1.47 ± 0.77 D, and -1.81 ± 1.10 D (P = 0.03), respectively, in the washout subgroup. The respective AL elongations were 0.50 ± 0.40 mm, 0.74 ± 0.41 mm, and 0.89 ± 0.53 mm (P < 0.001) for the continued treatment subgroups and 0.70 ± 0.47 mm, 0.82 ± 0.37 mm, and 0.98 ± 0.48 mm (P = 0.04) for the washout subgroup. The rebound SE progressions during washout were concentration dependent, but their differences were clinically small (P = 0.15). Older age and lower concentration were associated with smaller rebound effects in both SE progression (P < 0.001) and AL elongation (P < 0.001).

CONCLUSIONS

During the third year, continued atropine treatment achieved a better effect across all concentrations compared with the washout regimen. 0.05% atropine remained the optimal concentration over 3 years in Chinese children. The differences in rebound effects were clinically small across all 3 studied atropine concentrations. Stopping treatment at an older age and lower concentration are associated with a smaller rebound.

目的

(1) 比较在第三年继续和停止使用 0.05%、0.025%和 0.01%阿托品治疗的疗效。(2) 评估连续治疗 3 年的疗效。(3) 调查停止治疗后反弹现象及其决定因素。

设计

一项随机、双盲扩展试验。

参与者

共有 438 名 4 至 12 岁的儿童最初入选低浓度阿托品治疗近视进展研究（LAMP）。

方法

在第三年初，每组儿童按 1:1 的比例随机分为继续治疗和冲洗亚组。每 4 个月测量一次睫状肌麻痹等效球镜（SE）屈光度和眼轴（AL）。

主要观察指标

各组之间 SE 和 AL 的变化。

结果

共有 326 名儿童完成了 3 年的随访。在第三年，冲洗亚组的 SE 进展和 AL 伸长速度比继续治疗组快，所有浓度均如此：-0.68 ± 0.49 屈光度（D）比-0.28 ± 0.42 D（P < 0.001）和 0.33 ± 0.17 mm 比 0.17 ± 0.14 mm（P < 0.001）；0.05%组为-0.57 ± 0.38 D 比-0.35 ± 0.37 D（P = 0.004）和 0.29 ± 0.14 mm 比 0.20 ± 0.15 mm（P = 0.001）；0.025%组为-0.56 ± 0.40 D 比-0.38 ± 0.49 D（P = 0.04）和 0.29 ± 0.15 mm 比 0.24 ± 0.18 mm（P = 0.13）；0.01%组为-0.56 ± 0.40 D 比-0.38 ± 0.49 D（P = 0.04）和 0.29 ± 0.15 mm 比 0.24 ± 0.18 mm（P = 0.13）。在 3 年期间，继续治疗亚组的 SE 进展分别为-0.73 ± 1.04 D、-1.31 ± 0.92 D 和-1.60 ± 1.32 D（P = 0.001），冲洗亚组分别为-1.15 ± 1.13 D、-1.47 ± 0.77 D 和-1.81 ± 1.10 D（P = 0.03）。相应的 AL 伸长率分别为 0.50 ± 0.40 mm、0.74 ± 0.41 mm 和 0.89 ± 0.53 mm（P < 0.001），在继续治疗亚组和 0.70 ± 0.47 mm、0.82 ± 0.37 mm 和 0.98 ± 0.48 mm（P = 0.04）在冲洗亚组。冲洗期间的反弹 SE 进展与浓度有关，但差异较小（P = 0.15）。年龄较大和浓度较低与 SE 进展（P < 0.001）和 AL 伸长（P < 0.001）中的反弹效应较小有关。

结论

在第三年，与冲洗方案相比，继续使用阿托品治疗在所有浓度下均取得了更好的效果。在中国儿童中，0.05%阿托品在 3 年内仍是最佳浓度。在所有 3 种研究浓度下，反弹效果的差异在临床上较小。在年龄较大和浓度较低时停止治疗与反弹较小有关。

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