抗青光眼药物中防腐剂苯扎氯铵对患者眼压及眼表影响的Meta分析

Influence of benzalkonium chloride in anti-glaucoma medications on intraocular pressure and ocular surface:a Meta-analysis

目的采用二次文献分析法评估含苯扎氯铵(BAK)的抗青光眼药物应用后对眼压和眼表组织的影响。方法通过PubMed、EMbase、Cochrane Library数据库检索2000年1月1日至2016年12月31日采用抗青光眼药物治疗青光眼的相关文献,筛选局部用含与不含BAK的抗青光眼滴眼液对18岁及以上的多种类型青光眼及高眼压症患者眼压和眼表疾病观察的随机对照试验(RCT)文献。采用Excel表格统计相关数据,采用Cochrane系统对纳入的文献质量进行评价,用RevMan 5.3和Comprehensive Meta Analysis V3(CMA)统计学软件进行Meta分析。结果最终筛选出符合标准的RCT文献13篇。Meta分析结果显示,含与不含BAK的抗青光眼滴眼液均能有效降低眼压,2类滴眼液的降眼压幅度差异无统计学意义(SMD:-0.00,95%CI:-0.063~0.063,P=0.99,I 2=0%)。随访期内药物不良反应主要为结膜充血、角膜炎和干眼。2类滴眼液发生结膜充血、角膜炎和干眼的合并效应值差异均无统计学意义(OR=1.163,95%CI:0.896~1.509,P=0.257,I 2=51.6%;OR=1.15,95%CI:0.76~1.76,P=0.50,I 2=0%;OR=1.13,95%CI:0.79~1.61,P=0.51,I 2=40%)。结论抗青光眼滴眼液中的BAK对患者的降眼压效果无明显影响,短期内也不增加眼表组织的不良反应发生率。

Objective To evaluate the influence of benzalkonium chloride(BAK)in anti-glaucoma medication on intraocular pressure and ocular surface.Methods A Meta-analysis was performed.The literature about anti-glaucoma medications published in PubMed,EMbase,Cochrane Library from January 1,2000 to December 31,2016 were comprehensively searched to identify eligible studies.Randomized controlled trials(RCT)for intraocular pressure and ocular surface disease in anti-glaucoma eye drops with or without BAK in various types of glaucoma or ocular hypertension patients aged>18 years were collected.EXCEL tables were used to count the relevant data and Cochrane collaboration's tool was used to assess the risk of bias system and to evaluate the quality of studies.RevMan 5.3 and Comprehensive Meta Analysis(CMA)V3 were used to perform the Meta-analysis of all RCT.Results Thirteen RCTs were incorporated.With BAK or without BAK,anti-glaucoma eye drops could efficiently decrease intraocular pressure,meanwhile this comparison had no significant difference(SMD:-0.00,95%CI:-0.063-0.063,P=0.99,I 2=0%).Adverse events including conjunctival hyperemia,dry eye and keratitis between the two groups were analyzed.During the follow-up period,conjunctival hyperemia,dry eye and keratitis were the main adverse reactions.A random effect model was used for conjunctival hyperemia Meta-analysis,and the fixed effect model was used for dry eye and keratitis Meta-analysis.The combined effect values of conjunctival hyperemia,keratitis and dry eye were OR=1.163,95%CI:0.896-1.509,P=0.257,I 2=51.6%;OR=1.15,95%CI:0.76-1.76,P=0.50,I 2=0%;OR=1.13,95%CI:0.79-1.61,P=0.51,I 2=40%.Systematic comparison result showed that there were no statistically significant differences in the three adverse reactions between the two groups(all at P>0.05).Conclusions This Meta-analysis indicates that the reduction in intraocular pressure achieved by BAK-free eye drops is equivalent to the effect of eye drops with BAK,and the short term use of eye drops with BAK doesn't change the incidence of conjunctival hyperemia,keratitis and dry eye.