目的系统评价周边离焦软性角膜接触镜(PDSCLs)与单焦框架眼镜、单焦角膜接触镜(SVCLs)对儿童青少年近视进展的控制效果。
方法采用Meta分析方法，使用中文检索关键词近视、角膜接触镜、儿童、青少年、近视进展、眼轴、屈光不正和相关自由术语检索中国知网(CNKI)、万方数据和维普网(VIP)等数据库，使用英文检索关键词myopia、contact lens、children、adolescents、myopia progression、axial length、refractive error和相关英文自由术语检索PubMed、Medline、Embase和Cochrane Library。由2名研究人员独立收集数据，纳入将佩戴PDSCLs者作为试验组、佩戴单焦框架眼镜或SVCLs者作为对照组来控制儿童青少年近视的随机对照试验(RCT)研究文献。采用RCTs的Cochrane风险偏倚评估工具评估纳入研究的文献质量。本研究的评级指标为2个组间屈光度变化和眼轴长度变化的差异，合并效应量以加权均数差(WMD)和95%置信区间( CI)表示。采用 I 2检验评估各研究的异质性。试验组与对照组间的屈光度及眼轴长度的比较采用 Z检验。将附加度数≤+2.00 D、低像差、低焦深量的试验数据分配至低中附加组，附加度数>+2.00 D、高像差、高焦深量的试验数据分配至高附加组，采用亚组分析的方法探讨不同附加值PDSCLs对近视的控制效果。
结果共检索到378项研究，最终纳入10项高质量的RCT研究，共14组数据纳入Meta分析。纳入文献中受试者年龄6~18岁，随访时间10~36个月，包括试验组808例和对照组837例。其中有2项交叉试验研究未设置洗脱期，故仅纳入其首次干预后的结果。Meta分析结果显示试验组屈光度变化小于对照组，差异有统计学意义(WMD＝0.22 D，95% CI：0.15~0.30， Z＝5.65； P<0.05)；试验组眼轴长度短于对照组，差异有统计学意义(WMD＝－0.10 mm，95% CI：－0.12~－0.09， Z＝12.28； P<0.05)。亚组分析结果显示，低中附加亚组中，试验组和对照组屈光度变化和眼轴长度变化的WMD分别为0.21 D(95% CI：0.10~0.31)和－0.10 mm(95% CI：－0.13~－0.08)。高附加值亚组中，试验组与对照组屈光度变化和眼轴长度变化的WMD分别为0.26 D(95% CI：0.13~0.38)和－0.13 mm(95% CI：－0.15~－0.10)。
结论与单焦框架眼镜或SVCLs相比，PDSCLs可更有效地减缓儿童的近视进展，且PDSCLs附加度数较高时，减缓近视进展的效果更明显。
ObjectiveTo evaluate the effect of peripheral defocus soft contact lenses (PDSCLs), single-vision spectacles and single-vision contact lenses (SVCLs) on the progression of myopia in children and adolescents.
MethodsA meta-analysis was conducted.To collect relevant studies on the myopia control effect of PDSCLs in children, English databases including PubMed, Medline, Embase and Cochrane library were searched with myopia, contact lens, children, adolescents, myopia progression, axial length, refractive error and relevant free English terms as key words.Chinese databases including CNKI, Wanfang and VIP were searched with corresponding Chinese phrases and relevant free Chinese terms as key words.Randomized controlled trials (RCTs) on the myopia control effect in children and adolescents, with PDSCLs wearer as experimental group and single-vision spectacles or SVCLs wearer as control group, were independently collected by two researchers.Quality of included studies was evaluated with the Cochrane tool to assess risk of bias for RCTs.Combined effects of change in refraction and axial length between experimental and control groups was calculated by weighted mean difference (WMD) and 95%confidence interval ( CI). The heterogeneity of included studies was evaluated by I 2 statistic.The refraction and axial length of experimental and control groups were compared by Z test.Myopia control effect of different PDSCLs add powers was analyzed by subgroup analysis.The experimental data with add power ≤+ 2.00 D, low aberration and low depth of focus were assigned to low-medium add power subgroup, and the experimental data with add power >+ 2.00 D, high aberration and high depth of focus were assigned to high add power subgroup.
ResultsA total of 378 publications were retrieved.Finally, 10 high-quality RCTs and 14 groups of data were included in this meta-analysis.In these studies, 1 645 myopic children aged from 6 to 18 years were enrolled, including 808 cases in experimental group and 837 in control group.The follow-up ranged from 10 to 36 months.Among the 10 studies, there were two crossover trials without a washout period, so only the first intervention results were included.According to the meta-analysis, the change in refraction in experimental group was significantly less than that in control group (WMD=0.22 D, 95% CI: 0.15-0.30, Z=5.65; P<0.05). The change in axial elongation was significantly less in experimental group than control group (WMD=-0.10 mm, 95% CI: -0.12--0.09, Z=12.28; P<0.05). Subgroup analysis showed that the WMD of refraction change and axial elongation between experimental and control groups were 0.21 D (95% CI: 0.10-0.31) and-0.10 mm (95% CI: -0.13-0.08) in the low-medium add power subgroup, respectively, and were 0.26 D (95% CI: 0.13-0.38) and -0.13 mm (95% CI: -0.15--0.10) in the high add power subgroup, respectively.
ConclusionsPDSCLs have better myopia control effect than single-vision spectacles and SVCLs in children and adolescents.When the add power is higher, PDSCLs can slow the progression of myopia more effectively.
刘珠珠,魏瑞华,张翔宇,等. 周边离焦软性角膜接触镜控制儿童青少年近视进展Meta分析[J]. 中华实验眼科杂志,2022,40(11)：1046-1054.
DOI:10.3760/cma.j.cn115989-20210521-00314版权归中华医学会所有。
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除非特别声明，本刊刊出的所有文章不代表中华医学会和本刊编委会的观点。
刘珠珠：收集数据、参与选题、数据整理和分析、论文撰写；张翔宇：参与数据整理；裴如霞：论文修改；魏瑞华：参与选题、论文修改及定稿
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