目的：对0.05%环孢素A(CsA)滴眼液治疗干眼的安全性和有效性进行系统评价。

方法：检索PubMed、Web of Science、Cochrane图书馆、Embase、中国生物医学文献数据库、中国知网数据库、维普中文科技期刊数据库、万方数据库。纳入各数据库2016-01-01/2022-03-28 0.05%CsA滴眼液治疗干眼的随机对照试验。CsA组采用0.05%CsA滴眼液治疗，对照组采用人工泪液、安慰剂等进行治疗。采用ReMan 5.3软件对治疗后泪液分泌试验(SⅠt)、泪膜破裂时间(BUT)、角膜荧光素染色(CFS)、眼表疾病指数(OSDI)、不良反应进行Meta分析。

结果：共纳入13篇文献，共1 164例2 057眼。与对照组相比，CsA组SⅠt延长(MD=2.04，95%CI：1.75～2.33，P<0.00001)，BUT更久(MD=1.32，95%CI：0.87～1.76，P<0.00001)，CFS降低(MD=-0.79，95%CI：-1.20～-0.39，P=0.0001)，OSDI降低(MD=-5.52，95%CI：-9.14～-1.91，P=0.003)。但CsA组出现不良反应更多(OR=1.69，95%CI：1.06～2.72，P=0.03)。

结论：0.05%CsA可改善干眼患者的主观症状及各项客观指标。但与人工泪液等药物相比，0.05%CsA治疗后出现的眼部烧灼感等不良反应更多。

METHODS: PubMed, Web of Science, Cochrane Library, Embase, Chinese Bio-Medical Literature Database, CNKI, VIP, and Wan Fang Database were retrieved. Randomized controlled trials related to the treatment of dry eye with 0.05%CsA from January 1, 2016 to March 28, 2022 in each database were included. The CsA group was treated with 0.05% CsA eye drops, and the control group was treated with artificial tears and placebo. ReMan 5.3 was used for Meta-analysis of post-treatment Schirmer Ⅰ test(SⅠt), break up time(BUT), corneal fluorescein staining(CFS), ocular surface disease index(OSDI)and adverse effects.

RESULTS: A total of 13 literatures were included, which included 1 164 cases(2 057 eyes). Compared with the control group, the SIt in the CsA group was prolonged(MD=2.04, 95%CI: 1.75～2.33, P<0.00001), BUT was longer(MD=1.32, 95%CI: 0.87～1.76, P<0.00001), CFS decreased(MD=-0.79, 95%CI: -1.20～-0.39, P=0.0001)and OSDI decreased(MD=-5.52, 95%CI: -9.14～-1.91, P=0.003). However, the CsA group had more adverse reactions(OR=1.69, 95%CI: 1.06～2.72, P=0.03).

CONCLUSION: 0.05% CsA can improve the subjective symptoms and various objective indicators of dry eye patients. However, 0.05% CsA seems to produce more adverse effects, like ocular burning sensation when compared to drugs such as artificial tears.