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阿托品在儿童近视中的疗效与不良反应:一项荟萃分析。

Efficacy and Adverse Effects of Atropine in Childhood Myopia: A Meta-analysis.

作者信息

Gong Qianwen, Janowski Miroslaw, Luo Mi, Wei Hong, Chen Bingjie, Yang Guoyuan, Liu Longqian

机构信息

Department of Optometry and Visual Science, West China Hospital/West China School of Medicine, Sichuan University, Chengdu, China.

Institute for Cell Engineering, Division of Magnetic Resonance Research, Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Maryland3NeuroRepair Department, Mossakowski Medical Research Centre, Polish Academy of Sciences, Warsaw, Poland.

出版信息

JAMA Ophthalmol. 2017 Jun 1;135(6):624-630. doi: 10.1001/jamaophthalmol.2017.1091.

Abstract

IMPORTANCE

Some uncertainty about the clinical value and dosing of atropine for the treatment of myopia in children remains.

OBJECTIVE

To evaluate the efficacy vs the adverse effects of various doses of atropine in the therapy for myopia in children.

DATA SOURCES

Data were obtained from PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials, from inception to April 30, 2016. The reference lists of published reviews and clinicaltrials.gov were searched for additional relevant studies. Key search terms included myopia, refractive errors, and atropine. Only studies published in English were included.

STUDY SELECTION

Randomized clinical trials and cohort studies that enrolled patients younger than 18 years with myopia who received atropine in at least 1 treatment arm and that reported the annual rate of myopia progression and/or any adverse effects of atropine therapy were included in the analysis.

DATA EXTRACTION AND SYNTHESIS

Two reviewers independently abstracted the data. Heterogeneity was statistically quantified by Q, H, and I2 statistics, and a meta-analysis was performed using the random-effects model. The Cochrane Collaboration 6 aspects of bias and the Newcastle-Ottawa Scale were used to assess the risk for bias.

MAIN OUTCOMES AND MEASURES

The primary outcome was a difference in efficacy and the presence of adverse effects at different doses of atropine vs control conditions. The secondary outcomes included the differences in adverse effects between Asian and white patients.

RESULTS

Nineteen unique studies involving 3137 unique children were included in the analysis. The weighted mean differences between the atropine and control groups in myopia progression were 0.50 diopters (D) per year (95% CI, 0.24-0.76 D per year) for low-dose atropine, 0.57 D per year (95% CI, 0.43-0.71 D per year) for moderate-dose atropine, and 0.62 D per year (95% CI, 0.45-0.79 D per year) for high-dose atropine (P < .001), which translated to a high effect size (Cohen d, 0.97, 1.76, and 1.94, respectively). All doses of atropine, therefore, were equally beneficial with respect to myopia progression (P = .15). High-dose atropine were associated with more adverse effects, such as the 43.1% incidence of photophobia compared with 6.3% for low-dose atropine and 17.8% for moderate-dose atropine (χ22 = 7.05; P = .03). In addition, differences in the incidence of adverse effects between Asian and white patients were not identified (χ21 = 0.81; P = .37 for photophobia).

CONCLUSIONS AND RELEVANCE

This meta-analysis suggests that the efficacy of atropine is dose independent within this range, whereas the adverse effects are dose dependent.

摘要

重要性

阿托品用于治疗儿童近视的临床价值和给药剂量仍存在一些不确定性。

目的

评估不同剂量阿托品治疗儿童近视的疗效及不良反应。

数据来源

数据取自PubMed、EMBASE和Cochrane对照试验中心注册库,时间跨度从建库至2016年4月30日。检索已发表综述的参考文献列表及clinicaltrials.gov,以查找其他相关研究。主要检索词包括近视、屈光不正和阿托品。仅纳入英文发表的研究。

研究选择

纳入随机临床试验和队列研究,研究对象为18岁以下近视患者,至少有1个治疗组使用阿托品,并报告了近视进展的年速率和/或阿托品治疗的任何不良反应。

数据提取与合成

两名研究者独立提取数据。通过Q、H和I²统计量对异质性进行统计学量化,并使用随机效应模型进行荟萃分析。采用Cochrane协作组的6个偏倚方面及纽卡斯尔-渥太华量表评估偏倚风险。

主要结局与测量指标

主要结局是不同剂量阿托品与对照条件相比在疗效和不良反应方面的差异。次要结局包括亚洲和白人患者在不良反应方面的差异。

结果

分析纳入了19项独特研究,涉及3137名独特儿童。低剂量阿托品组与对照组在近视进展方面的加权平均差为每年0.50屈光度(D)(95%CI,每年0.24 - 0.76 D),中剂量阿托品组为每年0.57 D(95%CI,每年0.43 - 0.71 D),高剂量阿托品组为每年0.62 D(95%CI,每年0.45 - 0.79 D)(P <.001),这转化为较高的效应量(Cohen d分别为0.97、1.76和1.94)。因此,所有剂量的阿托品在近视进展方面同样有益(P =.15)。高剂量阿托品与更多不良反应相关,如畏光发生率为43.1%,而低剂量阿托品为6.3%,中剂量阿托品为17.8%(χ²2 = 7.05;P =.03)。此外,未发现亚洲和白人患者在不良反应发生率上存在差异(畏光方面χ²1 = 0.81;P =.37)。

结论与意义

这项荟萃分析表明,在此范围内阿托品的疗效与剂量无关,而不良反应与剂量有关。

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