不含苯扎氯铵的抗青光眼滴眼液疗效及安全性的Meta分析

Efficacy and safety of benzalkonium chloride(BAK)-free eye drops in treatment of glaucoma and ocular hypertension:a Meta-analysis

目的通过荟萃分析评价不含苯扎氯铵（BAK）的滴眼液治疗青光眼和高眼压症的有效性及安全性。设计荟萃分析。研究对象Medline（1966—2011年）、EMbase（1966—2010年）、Cochrane图书馆（2010年）及中国生物医学文献数据库CBM（1979—2010年）有关含与不含BAK的滴眼液治疗青光眼和高眼压症的临床对照研究文献资料。方法采用Cochrane系统评价的方法检索文献，按照纳入和排除标准限定研究对象，通过Jadad评分量表进行文献质量评估后，使用Cochrane协作网提供的RevMan4．2统计软件进行Meta分析，以获得两者治疗青光眼和高眼压症的疗效及安全性是否有差异的相关证据。主要指标眼压，药物不良反应。结果纳入含与不含BAK的滴眼液治疗青光眼和高眼压症的临床对照研究6项（2313眼）。Meta分析结果显示，两类滴眼液均能有效降低眼压，两类滴眼液的降眼压幅度差异为0．08mmHg（95％CI，一0．10～0．27）（P_0．38）。随访期内发生相对较多的三种药物不良反应为结膜充血（10．98％）、过敏性结膜炎（4．84％）和干眼（3．11％）。采用固定效应模型进行Mete分析，用两类滴眼液者发生结膜充血、过敏性结膜炎和眼干的合并比值比分别为1．37（95％ CI，1．05—1．80）、2．1（95％CI，1．26～3．48）和1．69（95％CI，1．13-2．53）（P〈0．05）。结论不含BAK的滴眼液降眼压效果与含有BAK的滴眼液的差异无统计学意义且安全性更高，但尚需更多高质量的前瞻性临床对照研究进一步证实。

Objectiv.e To evaluate the efficacy and safety of BAK-free eye drops in treatment of glaucoma and ocular hypertension. Design Meta-analysis. Participants Published literature in Medline（1966-2011）, EMbase（1966-2010）, Cochrane library（2010） and CBM （1979-2010） which compared antiglaucoma drugs containing BAK with BAK-free. Methods According to evaluation guidelines of Cochrane collaboration, clinical controlled trials of antiglaucoma drugs in treatment of glaucoma and ocular hypertension were searched using Medline, EMbase, the Cochrane Library and CBM. Methodology qualities of literatures were performed by experienced researchers according to the Jadad Score. RevMan 4.2 offered by Cochrane was used for Meta-analysis. Main Outcome Measures Intraocular pressure and drug adverse events. Results Only 6 literatures （2313 eyes） were included for Meta-analysis . The result of analysis showed that BAK-free eye drops could control the intraoptic pressure as well as eye drops containing BAK （P=0.38）. However, adverse event rates （such as conjunctival hyperemia, allergic conjunctivitis and dry eye） in BAK-free group were much lower than BAK containing group （P=0.02, 0.004, 0.01, respectively）. Conclusion Meta-analysis shows that BAK-free eye drops have equal efficacy and much better safety when compared with BAK containing eye drops in treatment of glaucoma and ocular hypertension. More high quality perspective studies are still required for further analysis.