Katonis Georgios, Tzamalis Argyrios, Tsinopoulos Ioannis, Ziakas Nikolaos
Postgraduate Master Program "Ocular Surgery", School of Medicine, Aristotle University of Thessaloniki, University Campus, 54124 Thessaloniki, Greece.
2nd Department of Ophthalmology, Aristotle University of Thessaloniki, Papageorgiou General Hospital, 56429 Thessaloniki, Greece.
J Clin Med. 2025 Jul 29;14(15):5347. doi: 10.3390/jcm14155347.
: Tacrolimus, an immunosuppressant, is increasingly used topically in ophthalmology, particularly for conditions like vernal keratoconjunctivitis and post-keratoplasty rejection prophylaxis. This systematic review aims to evaluate the efficacy and safety of topical tacrolimus in these ocular conditions. : A thorough search was conducted in PubMed and Cochrane Library for relevant studies published up to 16 March 2025. Studies were eligible for inclusion if they were randomized controlled trials investigating topical tacrolimus in human ocular disease, were published in English, and reported clearly defined outcomes. Exclusion criteria included non-randomized studies, animal studies, systemic treatments, non-English publications, and studies lacking clearly reported outcomes. Data regarding study design, patient demographics, intervention details, and outcomes were extracted and analyzed. The Cochrane risk-of-bias tool (RoB 2.0) was used to assess the risk of bias. : A total of 10 studies met the inclusion criteria, were retrieved, and were categorized as not highly biased after the risk-of-bias assessment. These studies were included in the systematic review, where a qualitative analysis took place. Our analysis revealed that the topical use of tacrolimus showed promising results, as it improved clinical signs and symptoms in most patients. In half of the studies, tacrolimus demonstrated superior efficacy compared to the control group, while in the remaining studies, it showed equivalent efficacy. Adverse effects, such as a burning sensation, were noted in 7/10 studies but were generally mild. The methodologies were somewhat heterogeneous, and some studies had small sample sizes. : Topical tacrolimus shows promising effects in managing various ocular surface diseases. While randomized controlled trials provide evidence, further research with larger sample sizes is necessary to solidify its efficacy and safety profile compared to other immunosuppressants.
他克莫司是一种免疫抑制剂，在眼科越来越多地用于局部用药，特别是用于春季角结膜炎和角膜移植术后排斥反应的预防等病症。本系统评价旨在评估局部应用他克莫司治疗这些眼部疾病的疗效和安全性。
在PubMed和Cochrane图书馆对截至2025年3月16日发表的相关研究进行了全面检索。如果研究是调查局部应用他克莫司治疗人类眼部疾病的随机对照试验、以英文发表且报告了明确界定的结果，则符合纳入标准。排除标准包括非随机研究、动物研究、全身治疗、非英文出版物以及缺乏明确报告结果的研究。提取并分析了有关研究设计、患者人口统计学、干预细节和结果的数据。使用Cochrane偏倚风险工具（RoB 2.0）评估偏倚风险。
共有10项研究符合纳入标准，被检索到，在偏倚风险评估后被归类为偏倚程度不高。这些研究被纳入系统评价并进行了定性分析。我们的分析表明，局部应用他克莫司显示出有希望的结果，因为它改善了大多数患者的临床体征和症状。在一半的研究中，他克莫司与对照组相比显示出更高的疗效，而在其余研究中，它显示出同等疗效。在10项研究中有7项注意到有烧灼感等不良反应，但一般较轻。方法存在一定异质性，一些研究样本量较小。
局部应用他克莫司在治疗各种眼表疾病方面显示出有希望的效果。虽然随机对照试验提供了证据，但与其他免疫抑制剂相比，仍需要进行更大样本量的进一步研究来巩固其疗效和安全性。
