Toshida Hiroshi, Funaki Toshinari, Ono Koichi, Tabuchi Nobuhito, Watanabe Sota, Seki Tamotsu, Otake Hiroshi, Kato Takuji, Ebihara Nobuyuki, Murakami Akira
Department of Ophthalmology, Juntendo University Shizuoka Hospital, Shizuoka.
Department of Ophthalmology, Juntendo University Graduate School of Medicine.
Drug Des Devel Ther. 2017 Jun 23;11:1871-1879. doi: 10.2147/DDDT.S137825. eCollection 2017.
The purpose of this study was to investigate the efficacy and safety of the administration of retinol palmitate (VApal) ophthalmic solution (500 IU/mL) for the treatment of patients with dry eye.
This study included 66 patients with dry eye. After a 2-week washout period, patients were randomized (1:1) into either a VApal ophthalmic solution or a placebo group, and a single drop of either solution was administered six times daily for 4 weeks. Efficacy measures were 12 subjective symptoms, rose bengal (RB) and fluorescein staining scores, tear film breakup time, and tear secretion. Safety measures included clinical blood and urine analyses and adverse event recordings.
In comparisons of the two groups, the mean change in RB staining score from baseline was significantly lower in the VApal group at 2 and 4 weeks (<0.05 and <0.01, respectively). Furthermore, the fluorescein clearance rate (fluorescein staining score) was significantly higher in the VApal group at 4 weeks (<0.05). The VApal group showed a significant improvement in blurred vision at 1 and 2 weeks (<0.01 and <0.05, respectively), and the mean change in the total score for subjective symptoms from baseline was significantly lower in the VApal group at 1 week (<0.05). In before- and after-intervention comparisons, the fluorescein and RB staining scores showed improvement in both groups. Improvement was noted for 11 subjective symptoms in the VApal group and for seven symptoms in the placebo group. No significant differences in adverse events and reactions were found between the groups.
VApal ophthalmic solution (500 IU/mL) is safe and effective for the treatment of patients with dry eye.
本研究旨在探讨棕榈酸视黄酯（VApal）眼药水（500 IU/mL）治疗干眼症患者的疗效和安全性。
本研究纳入66例干眼症患者。经过2周的洗脱期后，患者被随机（1:1）分为VApal眼药水组或安慰剂组，两组均每天滴眼6次，每次1滴，持续4周。疗效指标包括12项主观症状、孟加拉玫瑰红（RB）染色和荧光素染色评分、泪膜破裂时间和泪液分泌。安全性指标包括临床血液和尿液分析以及不良事件记录。
两组比较，VApal组在第2周和第4周时RB染色评分较基线的平均变化显著更低（分别为<0.05和<0.01）。此外，VApal组在第4周时荧光素清除率（荧光素染色评分）显著更高（<0.05）。VApal组在第1周和第2周时视力模糊症状有显著改善（分别为<0.01和<0.05），且VApal组在第1周时主观症状总分较基线的平均变化显著更低（<0.05）。干预前后比较，两组的荧光素和RB染色评分均有改善。VApal组有11项主观症状得到改善，安慰剂组有7项症状得到改善。两组间不良事件和反应无显著差异。
VApal眼药水（500 IU/mL）治疗干眼症患者安全有效。
