玻璃酸钠滴眼液治疗干眼临床随机对照试验的Meta分析

Meta-analysis of randomized controlled trials of sodium hyaluronate eye drops treating dry eye

背景 国内外有较多关于玻璃酸钠滴眼液治疗干眼疗效的报道,应用循证医学的方法对玻璃酸钠滴眼液的疗效进行评估具有重要的临床意义. 目的 运用Meta分析法评价玻璃酸钠滴眼液治疗干眼的疗效.方法 本研究为文献的二次研究设计.采用Cochrane系统综述方法,按照预先制定的检索策略,计算机检索PubMed、Medline、中国生物医学文献数据库网络版、中国知网数据库、重庆维普中文科技期刊数据库、万方数据库等电子文献数据库.检索年限从各数据库建库至2011年12月.由2名评价者共同评价所纳入研究的质量,纳入玻璃酸钠滴眼液治疗干眼的随机对照试验（RCTs）,并对纳入的文献采用Jadad量表进行质量评价.对同质性研究结果进行Meta分析,采用Cochrane协作网提供的RevMan 5.0软件进行Meta分析,对异质性研究进行描述性分析,以比值比（OR）值表示效应指标. 结果 共纳入4个符合纳入标准的RCTs研究文献,Jadad量表评价结果显示,2个文献7分、1个4分、1个2分,共包括686例干眼患者,其中试验组应用玻璃酸钠点眼治疗干眼者344例,应用安慰剂、生理盐水、羟甲基纤维素、羟丙甲纤维素作为对照者342例.试验组中症状改善者183例,对照组症状改善者130例.Meta分析结果显示,试验组与对照组治疗有效率的OR为2.55,95％可信区间（CI）为0.94～6.93,试验组改善症状的有效率与对照组比较差异无统计学意义（Z=1.84,P=0.07）.结论 玻璃酸钠滴眼液治疗干眼具有一定的疗效,但与对照组比较差异不明显.限于纳入研究的文献量有限,且质量参差不齐,仍然需要进行大样本、多中心RCTs分析以进一步证实玻璃酸钠治疗干眼的优越性.

Background Some researching results of sodium hyaluronate eye drops treating dry eye have been reported home and abroad.To evaluate these results using the method of evidence-based medicine （EBM） has an important clinical significance.Objective This secondary study was to systematically evaluate the efficacy of sodium hyaluronate eye drops for the treatment of dry eye.Methods Meta analysis was adopted in this study.The electronic bibliographic databases were searched according to the prescribed strategy,including Medline,PubMed,VIP,CBM,CNKI,Wanfang Data using the method of Cochrane systematic review.The literature published time was limited from the commencement of each database to December,2011.Randomized controlled trials （RCTs） of sodium hyaluronate eye drops treating dry eye were included and the methodological quality of the RCTs was assessed by two evaluators using Jadad measuring scale,and homogeneous evaluation by Meta-analysis was performed.Statistical analysis of clinical data was performed using RevMan 5.0 software provided by the Cochrane Collaboration.With odds ratio （OR） value as the effect index,the randomized effect model was used to analyze the clinical heterogeneity.Results A total of 4 RCTs involving 686 patients were included.Jadad scale evaluation showed 7 points in 2 literature,4 points in 1 literature and 2 points in 1 literature.In all the RCTs,344 patients with dry eye were treated using sodium hyaluronate as the sodium hyaluronate eye drops group,and 342 dry eyes applied placebo,normal saline solution,hydroxymethyl cellulose,hydroxypropyl methyl cellulose respectively as the control group.Meta-analysis indicated that the total effective rate （OR） was 2.55 with the 95% confidence interval （CI） 0.94-6.93.The symptoms were improved in 183 cases in the experiment group and 130 cases in the control group.No significant difference was found in the OR between the sodium hyaluronate eye drops group and the control group （Z =1.84,P=0.07）.Conclusions Meta-analysis indicates that sodium hyaluronate eye drops can improve the symptom of dry eye,but have no significence with the control group.However,owing to fewer number and uneven quality of included RCTs,the large sample size and multicenter of RCTs is still needed to verify the superiority of sodium hyaluronate eye drops for dry eye.