目的：探讨1g/L花青素护眼贴应用于轻中度干眼的临床疗效。

方法：本研究为前瞻性、多中心设计。收集2016-10/2017-04长沙、重庆、武汉等8家爱尔眼科医院轻、中度干眼患者共320例640眼，以随机数字表法分为护眼贴组(160例)和人工泪液组(160例)。护眼贴组夜间睡眠时使用1g/L花青素护眼贴6h以上； 人工泪液组滴用聚乙烯醇滴眼液4次/d。于治疗前1d及治疗后14d对症状及体征进行评价，症状评价采用眼表疾病指数(ocular surface disease index，OSDI)评分，体征观察包括泪液分泌试验(Schirmer I test，SⅠt)以及采用Oculus眼表综合分析仪测量非侵入式首次泪膜破裂时间(first noninvasive tear break-up time，NITBUTf)和非侵入式平均泪膜破裂时间(average noninvasive tear break-up time，NITBUTav)。

结果：两组患者治疗后的OSDI评分、NITBUTf、NITBUTav较治疗前有明显改善，差异有统计学意义(P<0.05)，SⅠt治疗前后差异无统计学意义(P>0.05)。两组间治疗后OSDI评分、NITBUTf、NITBUTav、SⅠt比较差异无统计学意义(P>0.05)。

结论：对于轻、中度干眼，1g/L花青素护眼贴与人工泪液具有类似的疗效，能有效改善干眼症状、提高泪膜稳定性。

METHODS: In this prospective and multicenter study, a total of 320 cases(640 eyes)with mild and moderate dry eye were enrolled from 8 Aier Eye Hospitals in Changsha, Chongqing, Wuhan and so on from October 2016 to April 2017. The patients were assigned to eye patch group(160 cases)and artificial tears group(160 cases)based on random number table. The patients in eye-patch group used 1g/L of anthocyanin eye-patch for more than 6h during night sleep, while the patients in artificial tears group used polyvinyl alcohol eye drops for 4 times per day. The evaluation of symptoms and signs were conducted on 1d before the treatment and 14d after the treatment. The evaluation of symptoms adopted the Ocular Surface Disease Index(OSDI), while the observation of signs included tear secretion test(Schirmer Ⅰ test, SⅠt), first noninvasive tear breakup time(NITBUTf)as well as average noninvasive tear breakup time(NITBUTav)measured by Oculus ocular surface analyser.

RESULTS: OSDI score, NITBUTf and NITBUTav in the two groups after treatment were significantly improved compared with that before treatment, and the difference had a statistical significance(P<0.05). While the difference of SⅠt in the two groups before and after treatment had no statistical significance(P>0.05). There was no significant difference in OSDI score, NITBUTf, NITBUTav and SⅠt between the two groups after treatment(P>0.05).

CONCLUSION: The 1g/L anthocyanin eye-patch has similar efficacy with artificial tears for mild and moderate dry eye, which can effectively improve the symptoms and tear film stability.