Kauss Hornecker M, Charles Weber S, Brandely Piat M-L, Darrodes M, Jomaa K, Chast F
Service de pharmacie clinique, hôpitaux universitaires Paris Centre, site Hôtel-Dieu, 2, rue d'Arcole, 75004 Paris, France.
Service de pharmacie clinique, hôpitaux universitaires Paris Centre, site Hôtel-Dieu, 2, rue d'Arcole, 75004 Paris, France.
J Fr Ophtalmol. 2015 Oct;38(8):700-8. doi: 10.1016/j.jfo.2015.02.008. Epub 2015 Sep 11.
The University Hospitals Paris Centre Pharmacy compounds three concentrations of cyclosporine eye drops: 20mg/mL (=2%); 5mg/mL (=0.5%) and 0.5mg/mL (=0.05%). Cyclosporine A 2% drops were developed in 1995 to prevent the rejection of high-risk cornea transplants after failure of topical steroids. The other concentrations of eye drops were developed for the treatment of various immune or inflammatory diseases of the cornea, conjunctiva and uvea. These eye drops are dispensed with a physician's prescription to hospitalized or ambulatory patients. A retrospective study over 4 years (2009-2013) was conducted to analyze the details of prescription and possible adverse events.
Dispensations made from January 1st, 2009 through December 31st, 2013 were studied, including patient age, dose of cyclosporine and practice location of prescribing physician. We also recorded the indications for cyclosporine eye drops in a sample of ambulatory patients. The analysis of local tolerability and the effect on visual comfort was based on questionnaires sent to the patients on cyclosporine 2% over a period of 2 months.
Cyclosporine eye drops prescription grew continuously from 2009 through 2013 for all concentrations. In 2013, 5,859 patients were treated, among which 3,616 patients with topical cyclosporine 2%, 1,681 patients with 0.5%, and 562 patients with 0.05%. In total, this represents 62,621 eye drops. Treated patients ranged from 1 week to 100 years old. Topical 2% cyclosporine is indicated in 61% of cases to prevent high-risk corneal graft rejection. Other indications are corneal ulcer (6%), atopic keratoconjunctivitis (5%), vernal keratoconjunctivitis (5%) and herpetic keratitis (4%). Topical 0.5% cyclosporine is prescribed primarily for dry eye syndrome (20%) and to prevent rejection of high-risk corneal transplantation (11%), to treat ocular rosacea (10%), vernal keratoconjunctivitis (10%), atopic keratoconjunctivitis (8%) and Sjögren's syndrome (7%). Topical 0.05% cyclosporine is prescribed primarily for dry eye syndrome resistant to conventional treatment (47%) and Sjögren's syndrome (21%). Local tolerability of topical cyclosporine was evaluated in 388 patients. The majority of patients (63%) did not experience any adverse effects. The main side effects are redness, burning sensation and itching.
Prescription of various formulations of topical cyclosporine is current practice for surgical indications: rejection of high-risk corneal transplantation; or medical indications: vernal or atopic keratoconjunctivitis and dry eye syndrome. Further prospective randomized studies would be necessary to validate formulations, doses and indications of cyclosporine eye drops.
巴黎大学医院中心药房配制三种浓度的环孢素滴眼液：20mg/mL（=2%）、5mg/mL（=0.5%）和0.5mg/mL（=0.05%）。2%的环孢素A滴眼液于1995年研发，用于在局部类固醇治疗失败后预防高危角膜移植排斥反应。其他浓度的滴眼液则用于治疗角膜、结膜和葡萄膜的各种免疫或炎症性疾病。这些滴眼液凭医生处方提供给住院或门诊患者。进行了一项为期4年（2009 - 2013年）的回顾性研究，以分析处方细节和可能的不良事件。
研究了2009年1月1日至2013年12月31日期间的配药情况，包括患者年龄、环孢素剂量以及开处方医生的执业地点。我们还记录了门诊患者中环孢素滴眼液的用药指征。基于在两个月内发送给使用2%环孢素患者的问卷，分析局部耐受性和对视觉舒适度的影响。
2009年至2013年期间，所有浓度的环孢素滴眼液处方量持续增长。2013年，5859名患者接受治疗，其中3616名患者使用2%的局部环孢素，1681名患者使用0.5%的，562名患者使用0.05%的。总计62621瓶滴眼液。接受治疗的患者年龄从1周至100岁不等。61%的病例中，2%的局部环孢素用于预防高危角膜移植排斥反应。其他指征包括角膜溃疡（6%）、特应性角结膜炎（5%）、春季角结膜炎（5%）和疱疹性角膜炎（4%）。0.5%的局部环孢素主要用于干眼症（20%）和预防高危角膜移植排斥反应（11%），治疗眼部酒渣鼻（10%）、春季角结膜炎（10%）、特应性角结膜炎（8%）和干燥综合征（7%）。0.05%的局部环孢素主要用于对传统治疗耐药的干眼症（47%）和干燥综合征（21%）。对388名患者评估了局部环孢素的耐受性。大多数患者（63%）未出现任何不良反应。主要副作用为眼红、烧灼感和瘙痒。
局部环孢素各种制剂的处方用于手术指征：高危角膜移植排斥反应；或医学指征：春季或特应性角结膜炎和干眼症。需要进一步的前瞻性随机研究来验证环孢素滴眼液的制剂、剂量和指征。
