角膜塑形镜控制青少年近视有效性及安全性的Meta分析

Efficacy and Safety of Orthokeratology for Slowing Myopia Progression in Children:A Meta-Analysis Study

目的:就角膜塑形镜对青少年近视患者的有效性及安全性进行Meta分析。方法:循证医学研究。以2017年1月前发表的角膜塑形镜控制儿童近视进展有效性和安全性的临床资料为目标,检索Medline及中国知网、万方数据库。通过Stata11.0对文献进行Meta分析。计算1年和2年时间的眼轴长度改变的加权均数差(WMD)和不良反应发生率的比值比(OR及95%CI),并按研究类型、种族、测量仪器等因素进行亚组分析。结果:共纳入14项研究,病例共2563例,其中塑形镜组1339例,框架镜组1224例。Meta分析结果显示:2年观察中,塑形镜组和框架镜组眼轴的变化量有显著差异,WMD=-0.361,95%CI:-0.604~0.118,1年观察中,塑形镜组和框架镜组眼轴的变化量有显著差异,WMD=-0.356,95%CI:-0.610^-0.102。随访1年后塑形镜组近视控制率为66.6%,随访2年后为51.3%[近视控制率=(塑形镜组眼轴变化量-框架镜组眼轴变化量)/框架镜组眼轴变化量]。2年随访时间内,塑形镜组和框架镜组不良反应发生率的OR=6.408,95%CI:2.460~16.688。结论:角膜塑形镜是一个有效且相对安全的控制儿童近视进展的方法。

Objective:To evaluate the efficacy and safety of orthokeratology for slowing myopia progression in children using meta-analysis.Methods:This study was evidence-based research.Studies about the efficacy and safety of orthokeratology,which have involved children,were obtained from Medline,CNKI,and Wan Fang before January 2017.Selected studies were processed in meta-analysis by using the Stata version 11.0.The pooled weighted mean difference(WMD),odds ratio(OR)and 95%confidence interval(CI)of the axial length change and adverse reaction rates during 1-year and 2-year follow-ups were calculated.Subgroup analysis was conducted based on study type,race,and measurement instruments.Results:Fourteen studies involving 2 563 subjects were included.There were 1 339 subjects in the orthokeratology group(experimental)and 1 224 subjects in the spectacle group(control).The results showed that during the 2-year follow-up,a statistically significant difference was observed in axial length change between the orthokeratology and control groups,with a WMD of-0.361 mm(95%CI:-0.604 to 0.118).During the 1-year follow-up,a statistically significant difference was observed in axial length change between the orthokeratology and control groups,with a WMD of-0.356(95%CI:-0.610 to-0.102).The myopia control rate was 66.6%and 51.3%in the 1-year and 2-year follow-ups,respectively(myopia control rate=change in axial length in the experimental group-change in axial length in the control group/change in axial length in the control group).The OR of the adverse rate between the orthokeratology and control groups in 2 years was 6.408(95%CI:2.460 to 16.688).Conclusions:Orthokeratology is effective and safe for slowing myopia progression in children.