Di Zazzo Antonio, Roberti Gloria, Mashaghi Alireza, Abud Tulio Batista, Pavese Daniela, Bonini Stefano
1 IRCCS-Fondazione GB Bietti , Rome, Italy .
2 Faculty of Mathematics and Natural Sciences, Leiden Academic Centre for Drug Research, Leiden University , Leiden, The Netherlands .
J Ocul Pharmacol Ther. 2017 Nov;33(9):670-677. doi: 10.1089/jop.2016.0117.
Chronic use of topical hypotensive therapies in glaucoma patients leads to chronic inflammation of the ocular surface, which decreases the success rate of long-term glaucoma management. The aim of this study is to evaluate the effect of topical palmitoylethanolamide (PEA) (Defluxa), a well-known anti-inflammatory and analgesic agent, in suppressing the ocular surface inflammation associated with the use of hypotensive eye drops.
In a pilot clinical trial, we enrolled 15 glaucomatous patients who received topical PEA (Defluxa) in addition to the current antiglaucoma drugs, while 15 glaucomatous patients did not receive any additional treatment. At 3 different time points (day 0, 15, and 30), signs of ocular surface involvement, adverse events, visual acuity, and intraocular pressure were assessed.
Topical PEA (Defluxa) was effective in increasing the Schirmer test (P < 0.05) and the tear film breakup time (T-BUT) (P < 0.0001), and improving the conjunctival hyperemia (P < 0.0001) by day 30, compared to baseline. Compared to control, by day 15, the conjunctival hyperemia score was significantly decreased in the PEA (Defluxa) group (P < 0.01), while the T-BUT and the Schirmer Test achieved a significant improvement by day 30 (P < 0.05; P < 0.01).
Our data suggests that topical PEA (Defluxa) is a safe, effective, and generally well-tolerated treatment to prevent or suppress ocular surface inflammation attributable to chronic glaucoma treatment.
青光眼患者长期使用局部降压疗法会导致眼表慢性炎症，从而降低青光眼长期治疗的成功率。本研究的目的是评估局部使用棕榈酰乙醇胺（PEA，商品名Defluxa）这种知名的抗炎和镇痛药，对抑制与使用降压眼药水相关的眼表炎症的效果。
在一项初步临床试验中，我们招募了15名青光眼患者，他们在使用当前抗青光眼药物的基础上还接受了局部PEA（Defluxa）治疗，而另外15名青光眼患者未接受任何额外治疗。在3个不同时间点（第0天、第15天和第30天），评估眼表受累体征、不良事件、视力和眼压。
与基线相比，到第30天时，局部PEA（Defluxa）在增加泪液分泌试验（P < 0.05）和泪膜破裂时间（T - BUT）（P < 0.0001）以及改善结膜充血（P < 0.0001）方面有效。与对照组相比，到第15天时，PEA（Defluxa）组的结膜充血评分显著降低（P < 0.01），而到第30天时，T - BUT和泪液分泌试验有显著改善（P < 0.05；P < 0.01）。
我们的数据表明，局部PEA（Defluxa）是一种安全、有效且总体耐受性良好的治疗方法，可预防或抑制因慢性青光眼治疗引起的眼表炎症。
