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评估日本学龄儿童停止使用 0.01%阿托品滴眼液治疗后的近视反弹效应。

Assessment of myopic rebound effect after discontinuation of treatment with 0.01% atropine eye drops in Japanese school-age children.

机构信息

Department of Ophthalmology, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Kyoto, 602-8566, Japan.

Department of Ophthalmology, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.

出版信息

Jpn J Ophthalmol. 2023 Sep;67(5):602-611. doi: 10.1007/s10384-023-01012-8. Epub 2023 Aug 7.

Abstract

PURPOSE

Having previously demonstrated the efficacy of 0.01% atropine eye drops for inhibiting progression of childhood myopia, we conducted additional analyses to assess post-treatment changes in myopia progression.

STUDY DESIGN

Analysis of follow-up data from a previously reported randomized controlled trial METHODS: A mixed-effects model was used to compare intergroup changes in spherical equivalent (SE) and axial length (AL) at 1 month and 12 months after discontinuation of 2-year treatment with atropine or placebo in 167 school-age children.

RESULTS

Follow-up measurements were available for 149 participants at 1 month after discontinuation of treatment and for 51 participants at 12 months after discontinuation. At 1 month post-treatment, differences between the atropine and placebo groups in least squares (LS) mean changes in SE and AL, respectively, from 24 months were -0.06 diopters (D) (95% CI: -0.21, 0.08; P = .39) and 0.02 mm (95% CI: -0.05, 0.08; P = .60). At 12 months post-treatment, intergroup differences (atropine vs placebo) in LS mean changes in SE and AL, respectively, were -0.13 D (95% CI: -0.35, 0.10; P = .26) and -0.02 mm (95% CI: -0.12, 0.09; P = .75). LS mean changes in SE and AL from treatment discontinuation did not differ between the groups at 1 or 12 months post-treatment.

CONCLUSION

Axial elongation was significantly less in the atropine group than in the placebo group. The suppression effect obtained at 2 years was maintained after 12 months. The absence of intergroup differences in myopia progression since treatment cessation suggests that myopic rebound did not occur.

摘要

目的

我们之前已经证明了 0.01%阿托品滴眼液抑制儿童近视进展的疗效,在此基础上,我们进行了进一步的分析,以评估治疗停止后的近视进展变化。

研究设计

对之前报道的一项随机对照试验的随访数据进行分析

方法

采用混合效应模型比较 167 名学龄儿童在停止为期 2 年的阿托品或安慰剂治疗后 1 个月和 12 个月时,两组间球镜等效(SE)和眼轴(AL)的变化。

结果

149 名参与者在治疗停止后 1 个月时可进行随访测量,51 名参与者在治疗停止后 12 个月时可进行随访测量。治疗停止后 1 个月时,与安慰剂组相比,阿托品组 SE 和 AL 的最小二乘均数(LS)变化差异分别为-0.06 屈光度(D)(95%可信区间:-0.21,0.08;P=0.39)和 0.02 毫米(95%可信区间:-0.05,0.08;P=0.60)。治疗停止后 12 个月时,SE 和 AL 的 LS 平均变化差异分别为-0.13 D(95%可信区间:-0.35,0.10;P=0.26)和-0.02 毫米(95%可信区间:-0.12,0.09;P=0.75)。治疗停止后 1 个月和 12 个月时,两组 SE 和 AL 的 LS 平均变化无差异。

结论

与安慰剂组相比,阿托品组眼轴伸长明显减少。治疗 2 年后获得的抑制效果在 12 个月后仍能维持。治疗停止后近视进展无组间差异表明近视反弹并未发生。

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