目的：系统评价利非斯特治疗干眼症有效性与安全性，为干眼症的药物治疗提供选择依据。

方法：计算机检索中国知网、万方、维普、中国生物医学文献数据库、PubMed、Embase和The Cochrane Library数据库，收集利非斯特相关临床研究，检索时限从建库至2019-03。根据制定的纳入标准、排除标准对收集的文献进行严格筛选，采用Cochrane协作网偏倚风险评估工具对纳入的研究进行质量评价，使用Rev Man5.3软件对疗效和安全性指标进行Meta分析。

结果：本研究共纳入5项符合纳入标准的随机对照研究，合计样本量2 465例。Meta分析结果显示：与安慰剂比较，在84d的治疗后，角膜染色评分(CSS)变化\〖MD=-0.17，95%CI(-0.29，-0.05)，P=0.006\〗，眼干燥评分(EDS)变化\〖MD=-7.95，95%CI(-11.96，-3.93)，P=0.0001\〗，差异均有统计学意义。提示利非斯特滴眼液治疗干眼症的疗效优于安慰剂。安全性方面，严重不良反应发生率\〖OR=0.95，95%CI(0.50，1.81)，P=0.88\〗，差异无统计学意义； 常见不良反应方面，在滴眼部位不适、滴眼部位反应及味觉障碍等不良反应的发生率利非斯特组高于安慰剂组(P<0.05)。

结论：利非斯特治疗干眼症疗效确切，安全性较好。

METHODS: Randomized controlled trials about lifitegrast in the treatment of dry eye disease were searched in CNKI, VIP, CBM, PubMed, Embase and The Cochrane Library databases from inception to March 2019. The collected literatures were strictly screened according to the established inclusion and exclusion criteria, and the Cochrane collaborative network bias risk assessment tool was used to evaluate the quality of the included studies, RevMan 5.3 software was used for meta-analysis of efficacy and safety indicators.

RESULTS: A total of 5 randomized controlled trials that met the inclusion criteria were included in this study, with a total sample size of 2 465 participants. According to the result of Meta-analysis: compared with placebo, after 84d of treatment, the score of corneal staining(CSS)\〖MD= -0.17, 95% CI (-0.29, -0.05), P=0.006\〗, the score of eye dryness(EDS)\〖MD= -7.95, 95% CI (-11.96, -3.93), P=0.0001\〗, all the differences were statistically significant. It showed that lifitegrast eye drops had better effect than placebo in the treatment of dry eye disease. In terms of safety, the incidence of severe adverse reactions \〖OR=0.95, 95% CI (0.50, 1.81), P=0.88\〗; in terms of common adverse reactions, the incidence of adverse reactions such as instillation site irritation, instillation site reaction and dysgeusia were higher than that of placebo(P<0.05).

CONCLUSION: Lifitegrast is effective and safe in the treatment of dry eye disease.