Kiliç Adil, Gürler Bülent
Department of Opthalmology, Tatvan Military Hospital, Turkey.
Can J Ophthalmol. 2006 Dec;41(6):693-8. doi: 10.3129/i06-061.
A double-masked, placebo-controlled trial to evaluate the short-term efficacy and safety of topical 2% cyclosporine A in preservative-free artificial tears for patients with vernal keratoconjunctivitis.
Twenty patients with severe vernal keratoconjunctivitis were included in the study. All were treated with topical 2% cyclosporine A eye drops. One eye of each patient was administered 2% cyclosporine A in preservative-free artificial tears; the fellow eye received the placebo (vehicle) for the first 2 weeks, in a double-masked, placebo-controlled trial. Thereafter, the placebo eye received cyclosporine A (open trial). Symptoms and signs were scored on the day of enrollment and at the end of week 2, 4, and 14.
At the end of week 2, no statistically significant decrease was noted from baseline in mean scores of either signs (p = 0.18) or symptoms (p = 0.50) in the eyes that received placebo. On the other hand, a statistically significant decrease was observed in both sign and symptom scores (p < 0.001, for both) of eyes that received cyclosporine A. Significant differences were also noted at 2 weeks in mean scores of both signs and symptoms (p < 0.001, for both) between the eyes that received cyclosporine A and those that received placebo. At week 4 and 14, statistically significant decreases in both sign scores and symptom scores were noted compared with baseline in the eyes that received cyclosporine A and in the eyes that had initially received placebo (p < 0.001, for all).
Topical 2% cyclosporine A in preservative-free artificial tears is effective in alleviating signs and symptoms of patients with severe vernal keratoconjunctivitis and had no observed side effects over the course of the study.
一项双盲、安慰剂对照试验，以评估不含防腐剂的人工泪液中2%环孢素A局部用药对春季角结膜炎患者的短期疗效和安全性。
20例重度春季角结膜炎患者纳入本研究。所有患者均接受2%环孢素A滴眼液局部治疗。在一项双盲、安慰剂对照试验中，每位患者的一只眼睛滴入不含防腐剂的人工泪液中含2%环孢素A的滴眼液；另一只眼睛在前2周接受安慰剂（赋形剂）。此后，安慰剂组眼睛改用环孢素A（开放试验）。在入组当天以及第2、4和14周结束时对症状和体征进行评分。
在第2周结束时，接受安慰剂的眼睛，体征（p = 0.18）或症状（p = 0.50）的平均评分与基线相比无统计学显著下降。另一方面，接受环孢素A的眼睛，体征和症状评分均有统计学显著下降（两者p < 0.001）。接受环孢素A的眼睛与接受安慰剂的眼睛在体征和症状平均评分上在2周时也有显著差异（两者p < 0.001）。在第4周和第14周，与基线相比，接受环孢素A的眼睛以及最初接受安慰剂的眼睛，体征评分和症状评分均有统计学显著下降（所有p < 0.001）。
不含防腐剂的人工泪液中局部使用2%环孢素A可有效缓解重度春季角结膜炎患者的体征和症状，且在研究过程中未观察到副作用。
