Hingorani M, Moodaley L, Calder V L, Buckley R J, Lightman S
Moorfields Eye Hospital, London, United Kingdom.
Ophthalmology. 1998 Sep;105(9):1715-20. doi: 10.1016/S0161-6420(98)99043-1.
This study aimed to investigate the therapeutic effect of topical cyclosporin A (CsA) 2% in maize oil as a steroid-sparing agent in steroid-dependent atopic keratoconjunctivitis.
Prospective, randomized, double-masked, placebo-controlled trial.
Twenty-one patients with steroid-dependent atopic keratoconjunctivitis were studied.
Patients used either topical CsA or vehicle four times daily for 3 months in addition to their usual therapy, and the clinical response was used to taper or stop topical steroids when possible.
Steroid drop usage per week, ability to cease steroid use, scores for symptoms and clinical signs, drop side effects, and overall subjective rating of trial drop by patients and clinician were measured.
Cyclosporin A had a greater steroid-sparing effect than did placebo. Nine of 12 CsA patients ceased steroids compared to 1 of 9 placebo patients (P = 0.01), the final steroid use was lower in the CsA group (2.6 +/- 1.4 vs. 27.7 +/- 17.7, P = 0.005), and the mean reduction in steroid use was greater for CsA (85.5 +/- 14.7 vs. 13.9 +/- 16.0, P = 0.005). Clinical signs and symptom scores were reduced to a greater level for CsA. Serious side effects were lid skin maceration in one patient using CsA and an allergic reaction in one placebo patient. Marked blurring of vision after drop instillation was common in both groups, but intense stinging was more common in CsA patients (9/12 vs. 1/9, P = 0.01), limiting frequency of drop use. The clinician rated the trial drops as good or excellent more frequently for CsA (11/12 vs. 0/9, P < 0.0001).
Topical CsA is an effective and safe steroid-sparing agent in atopic keratoconjunctivitis and, despite difficulties in patient tolerance, also improves symptoms and signs.
本研究旨在探讨2%环孢素A（CsA）玉米油溶液作为一种类固醇节省剂在依赖类固醇的特应性角结膜炎中的治疗效果。
前瞻性、随机、双盲、安慰剂对照试验。
对21例依赖类固醇的特应性角结膜炎患者进行了研究。
患者除常规治疗外，每天使用局部CsA或赋形剂4次，持续3个月，并根据临床反应尽可能减少或停用局部类固醇。
测量每周类固醇滴眼液的使用量、停止使用类固醇的能力、症状和临床体征评分、滴眼液副作用以及患者和临床医生对试验滴眼液的总体主观评价。
环孢素A的类固醇节省效果优于安慰剂。12例CsA患者中有9例停用了类固醇，而9例安慰剂患者中只有1例停用（P = 0.01），CsA组最终类固醇使用量更低（2.6±1.4对27.7±17.7，P = 0.005），CsA组类固醇使用量的平均减少幅度更大（85.5±14.7对13.9±16.0，P = 0.005）。CsA组的临床体征和症状评分降低到了更高水平。严重副作用包括1例使用CsA的患者出现眼睑皮肤浸渍，1例安慰剂患者出现过敏反应。两组患者滴眼药水后均常见明显视力模糊，但强烈刺痛在CsA患者中更常见（9/12对1/9，P = 0.01），限制了滴眼液的使用频率。临床医生对CsA试验滴眼液的评价为良好或优秀的频率更高（11/12对0/9，P < 0.0001）。
局部使用CsA是特应性角结膜炎中一种有效且安全的类固醇节省剂，尽管患者耐受性存在困难，但也能改善症状和体征。
