目的 评价不含苯扎氯铵的滴眼液治疗青光眼和高眼压症的有效性及安全性。
方法 荟萃分析。采用Cochrane系统评价的方法,检索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)有关含与不含苯扎氯铵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,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RevMan 4.2统计软件进行Meta分析,以获得二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。
结果 共纳入含与不含苯扎氯铵的滴眼液治疗青光眼和高眼压症的临床对照研究共6项(2313只眼)。各项研究中的眼内压降低效果存在异质性,采用随机效应模型,将纳入的研究结果进行Meta分析。结果显示,两类滴眼液均能有效的降低眼内压,使用两类滴眼液的患者眼内压降低幅度的差异为0.08mmHg (95%CI, -0.10~0.27),P=0.38,差异无统计学意义。随访期内发生相对较多的三种不良反应为:结膜充血(10.98%)、过敏性结膜炎(4.84%)和眼干(3.11%)。采用固定效应模型进行Mete分析,使用两类滴眼液的患者发生结膜充血、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),此差异具有显著的统计学意义(P<0.05)。
结论 不含苯扎氯铵的滴眼液降低青光眼和高眼压症患者的眼内压的效果与含有苯扎氯铵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。
Objective To evaluate the efficacy and safety in treatment of glaucoma and ocular hypertension by BAK-free eye drops. Methods A Meta analysis. According to evaluation guidelines of Cochrane collaboration, clinical controlled trials (CCTs) comparing antiglaucoma drugs preserved with benzalkonium chloride (BAK) or not 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 to do the meta-analysis.
Results Only 6 literatures came into meta-analysis (2313 eyes). 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 oral dryness) 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 has 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. |