Tauber J, Davitt W F, Bokosky J E, Nichols K K, Yerxa B R, Schaberg A E, LaVange L M, Mills-Wilson M C, Kellerman D J
Tauber Eye Center, Kansas City, MO 64111, USA.
Cornea. 2004 Nov;23(8):784-92. doi: 10.1097/01.ico.0000133993.14768.a9.
To investigate the safety and efficacy of diquafosol tetrasodium, a P2Y2 receptor agonist that stimulates fluid and mucin secretion on the ocular surface, as a novel topical treatment of dry eye disease.
Subjects with dry eye (n=527) were evaluated in a randomized, double-masked, parallel-group trial comparing 24 weeks of treatment with 2 concentrations of diquafosol (1% and 2%) versus placebo instilled 4 times daily. Corneal staining, conjunctival staining, Schirmer tests, and subjective symptoms of dry eye were evaluated. Use of artificial tears was permitted as necessary.
Subjects treated with 2% diquafosol had significantly lower corneal staining scores compared with placebo at the 6-week, primary efficacy time point (P<0.001), and superiority continued throughout the 24-week study. Reductions in corneal staining were observed as early as after 2 weeks of treatment, were maintained throughout the 24-week study, and were observed to worsen slightly (toward baseline) when diquafosol treatment was discontinued (week 25). Results for conjunctival staining were consistent with those observed for corneal staining. Schirmer scores at week 6 were significantly higher with diquafosol treatment than with placebo (P<or=0.030). The percentage of subjects with clearing of foreign body sensation (score of 0) was higher at week 6 in subjects treated with 2% diquafosol (21%) compared with placebo (15%), but the difference did not achieve significance (P=0.193). Significant differences in favor of diquafosol were observed for clearing of foreign body sensation and for worst symptom in secondary data analyses.
Diquafosol tetrasodium was well tolerated and was superior to placebo (vehicle) in reducing corneal staining and in relieving certain patient symptoms. Diquafosol has a favorable risk/benefit profile in a broad spectrum of patients with dry eye disease and is a novel topical treatment of dry eye.
研究新型局部用药四磷酸二喹法索（一种刺激眼表液体和黏蛋白分泌的P2Y2受体激动剂）治疗干眼症的安全性和有效性。
在一项随机、双盲、平行组试验中对527例干眼症患者进行评估，比较每日4次滴注2种浓度（1%和2%）的二喹法索治疗24周与安慰剂的疗效。评估角膜染色、结膜染色、泪液分泌试验及干眼主观症状。必要时允许使用人工泪液。
在6周这个主要疗效时间点，与安慰剂相比，接受2%二喹法索治疗的患者角膜染色评分显著更低（P<0.001），且在整个24周研究期间这种优势一直持续。角膜染色减少最早在治疗2周后即可观察到，在整个24周研究期间持续存在，并且在停用二喹法索治疗时（第25周）观察到有轻微恶化（趋向基线水平）。结膜染色结果与角膜染色观察结果一致。第6周时，二喹法索治疗组的泪液分泌试验评分显著高于安慰剂组（P≤0.030）。在第6周时，接受2%二喹法索治疗的患者中异物感消失（评分为0）的比例为21%，高于安慰剂组的15%，但差异无统计学意义（P=0.193）。在次要数据分析中，在异物感消失和最严重症状方面观察到二喹法索具有显著优势。
四磷酸二喹法索耐受性良好，在减少角膜染色和缓解患者某些症状方面优于安慰剂（赋形剂）。二喹法索在广泛的干眼症患者中具有良好的风险/效益比，是一种新型的干眼症局部治疗药物。
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