Long-term use of topical tacrolimus ointment: a safe and effective option for the treatment of vernal keratoconjunctivitis

ABSTRACT Purpose: To assess the compliance, efficacy, and safety of the long-term use of topical tacrolimus for the clinical management of vernal keratoconjunctivitis. Methods: The medical records of patients with vernal keratoconjunctivitis undergoing long-term treatment with 0.03% topical tacrolimus were retrospectively reviewed. The duration of tacrolimus use and the causes for drug discontinuation were used to assess treatment compliance. To assess drug efficacy, the need for and the number of times that topical corticosteroids were used to control symptoms were registered. Side effects related to tacrolimus use were monitored to determine drug safety. Results: The study cohort consisted of 21 patients who met the eligibility criteria. The mean duration of tacrolimus use was 41.3 ± 18.5 months. Fourteen patients (66.7%) continuously used tacrolimus, and three (14.3%) discontinued treatment following complete remission. Four patients (19%) did not use tacrolimus as prescribed or interrupted tacrolimus use on their own: two (9.5%) because of discomfort upon application and two (9.5%) because of the lack of improvement. Ten patients (47.6%) maintained disease control without the use of corticosteroids, whereas 11 (52.4%) required an average of 2.70 ± 1.35 corticosteroid cycles to control symptoms. The only reported side effect was discomfort upon application. Conclusions: Despite the small sample size and study design limitations, these results support the long-term use of topical tacrolimus as an effective and safe option for the treatment of vernal keratoconjunctivitis, with good compliance of patients to the treatment.

摘要
研究目的：评估长期外用他克莫司（topical tacrolimus）用于春季角结膜炎（vernal keratoconjunctivitis）临床管理的依从性、疗效与安全性。
研究方法：回顾性分析接受0.03%外用他克莫司长期治疗的春季角结膜炎患者的临床病历资料。以他克莫司用药时长及停药原因作为评估治疗依从性的指标；为评估药物疗效，记录患者控制症状所需外用糖皮质激素（topical corticosteroids）的使用需求与频次；通过监测他克莫司相关不良反应以评估用药安全性。
研究结果：本研究队列共纳入符合入组标准的21例患者，患者他克莫司的平均用药时长为41.3±18.5个月。14例患者（66.7%）持续使用他克莫司，3例（14.3%）在疾病完全缓解后停药；4例患者（19%）未按医嘱使用他克莫司或自行中断用药，其中2例（9.5%）因用药时出现不适，2例（9.5%）因症状无改善。10例患者（47.6%）未使用糖皮质激素即可维持疾病控制，而11例患者（52.4%）平均需要2.70±1.35个糖皮质激素治疗周期以控制症状。本研究仅报道的不良反应为用药时出现不适感。
研究结论：尽管本研究样本量较小且研究设计存在一定局限，但结果支持长期外用他克莫司可作为治疗春季角结膜炎的有效且安全的选择，且患者对该治疗的依从性良好。