Wakamatsu Tais Hitomi, Tanaka Mari, Satake Yoshiyuki, Dogru Murat, Fukagawa Kazumi, Igarashi Ayako, Fujishima Hiroshi
Johnson & Johnson Department of Ocular Surface and Visual Optics, Keio University School of Medicine, Tokyo, Japan.
Mol Vis. 2011 Apr 13;17:932-8.
To examine the clinical efficacy and anti-inflammatory effects of tacrolimus eye drops; we studied the changes in clinical ocular findings and measured tear eosinophil cationic protein (ECP) levels of atopic keratoconjunctivitis (AKC) patients before and after the treatment.
Nine eyes of 9 patients (8 males, 1 female; mean age: 16.9 ± 11.4 years; range: 6-44 years) diagnosed with moderate or severe AKC disease were enrolled in this prospective study and treated with tacrolimus. All patients received 0.1% tacrolimus eye drops 2 times a day for 1 month. Tear samples were taken before and after treatment and ECP concentrations were obtained. Corneal fluorescein staining and conjunctival injection, edema, and papillary formation were graded on the recruitment day and one month later. Analysis of pre- and post-treatment findings was done using the Wilcoxon signed test. The ECP concentrations were correlated with the clinical signs using Spearman correlation tests.
Post-treatment tear ECP levels were significantly reduced compared to the pre-treatment level. Clinical corneal scores also improved significantly after one month treatment with tacrolimus eye-drops. The mean conjunctival injection and conjunctival edema scores were significantly (p<0.05) decreased after the drug therapy. Strong positive linear correlations between ECP values and clinical signs were observed. Patients did not present side effects during the treatment with tacrolimus.
In this pilot study, tacrolimus eye drops were found to reduce signs of AKC. ECP proved to correlate well with clinical signs of AKC.
为了研究他克莫司滴眼液的临床疗效和抗炎作用；我们研究了特应性角结膜炎（AKC）患者治疗前后临床眼部表现的变化，并测量了泪液嗜酸性粒细胞阳离子蛋白（ECP）水平。
本前瞻性研究纳入了9例（8例男性，1例女性；平均年龄：16.9±11.4岁；范围：6 - 44岁）被诊断为中度或重度AKC疾病的患者的9只眼睛，并用他克莫司进行治疗。所有患者每天使用0.1%他克莫司滴眼液2次，持续1个月。在治疗前后采集泪液样本并测定ECP浓度。在入组当天和1个月后对角膜荧光素染色、结膜充血、水肿和乳头形成进行分级。使用Wilcoxon符号秩检验对治疗前后的结果进行分析。使用Spearman相关检验分析ECP浓度与临床体征之间的相关性。
与治疗前水平相比，治疗后泪液ECP水平显著降低。使用他克莫司滴眼液治疗1个月后，临床角膜评分也显著改善。药物治疗后结膜充血和结膜水肿的平均评分显著（p<0.05）降低。观察到ECP值与临床体征之间存在强正线性相关性。患者在使用他克莫司治疗期间未出现副作用。
在这项初步研究中，发现他克莫司滴眼液可减轻AKC的体征。ECP被证明与AKC的临床体征密切相关。
