局部滴注0.1%阳离子乳剂环孢素A后异基因造血干细胞移植患者的结膜T细胞谱
Conjunctival T Cell Profile in Allogeneic Hematopoietic Stem Cell Transplant Patients after Instilling Topical Cyclosporine-A 0.1% Cationic Emulsion.
作者信息
Tong Louis, Lim Elizabeth Wen Ling, Yeo Sharon Wan Jie, Hou Aihua, Linn Yeh Ching, Ho Aloysius, Than Hein, Quek Jeffrey Kim Siang, Hwang William Ying Khee, Lim Francesca Lorraine Wei Inng, Lim Li
机构信息
Corneal and External Eye Disease Service, Singapore National Eye Centre, 11 Third Hospital Avenue, Singapore, 168751, Singapore.
Ocular Surface Research Group, Singapore Eye Research Institute, 20 College Road Discovery Tower Level 6, The Academia, Singapore, 169856, Singapore.
出版信息
Ophthalmol Ther. 2023 Jun;12(3):1547-1567. doi: 10.1007/s40123-023-00686-0. Epub 2023 Mar 1.
INTRODUCTION
To profile conjunctival T cell populations in allogeneic hematopoietic stem cell transplant (HSCT) patients after instillation of daily topical cyclosporine-A (CsA) 0.1% cationic emulsion (Ikervis), and to evaluate patients' tolerance to these eye drops.
METHODS
Nineteen participants were prescribed Ikervis prophylaxis once daily to both eyes from 3-5 weeks pre-HSCT to 12 months post-HSCT. The outcome measure was conjunctival T cell proportions from flow cytometry after impression cytology. Covariates included visual acuity, intraocular pressure, slit lamp and fundal examination, dry eye (SPEED) and quality of life questionnaires, non-invasive keratograph tear break-up time (NIKBUT), conjunctival redness, meibography, lipid thickness, Schirmer test, tear cytokines, fluorescein staining, tear osmolarity, and meibomian gland expressibility.
RESULTS
The conjunctival T cell analysis showed either stable or decreased proportions of conjunctival CD4 T cells at the last visit from baseline in compliant patients. CD4 proportions were increased in non-compliant patients and in the single patient who developed ocular graft-versus-host disease (GVHD). All patients were tolerant to Ikervis but 6/19 were not compliant. In the majority of patients, vision did not affect activities of daily living. Pre- and post-HSCT up to the last study visit, there was no statistically significant change in clinical covariates. Only one participant developed ocular GVHD at 9 months post-HSCT.
CONCLUSION
Superficial conjunctival T cell profile reflects compliance to daily topical Ikervis eye drops and clinical ocular surface parameters in allogenic HSCT patients. Tolerance is comparable to other formulations of topical CsA in the first 12 months.
GOV IDENTIFIER
NCT04636918. URL: https://clinicaltrials.gov/ct2/show/NCT04636918?cond=ocular+Graft+Versus+Host+Disease&cntry=SG&draw=2&rank=2 .
引言
描述接受同种异体造血干细胞移植（HSCT）的患者在每日滴注0.1%阳离子乳液环孢素A（CsA，Ikervis）后的结膜T细胞群体特征，并评估患者对这些滴眼液的耐受性。
方法
19名参与者在HSCT前3 - 5周直至HSCT后12个月期间，每天双眼使用一次Ikervis进行预防。结果测量指标为印片细胞学检查后通过流式细胞术检测的结膜T细胞比例。协变量包括视力、眼压、裂隙灯和眼底检查、干眼（SPEED）和生活质量问卷、非侵入性角膜地形图泪膜破裂时间（NIKBUT）、结膜充血、睑板腺造影、脂质厚度、泪液分泌试验、泪液细胞因子、荧光素染色、泪液渗透压以及睑板腺可挤压性。
结果
结膜T细胞分析显示，依从性良好的患者在最后一次随访时结膜CD4 T细胞比例与基线相比保持稳定或下降。非依从性患者以及发生眼部移植物抗宿主病（GVHD）的唯一一名患者的CD4比例升高。所有患者对Ikervis均耐受，但19名患者中有6名不依从。在大多数患者中，视力并未影响日常生活活动。在HSCT前后直至最后一次研究随访，临床协变量无统计学显著变化。仅一名参与者在HSCT后9个月发生眼部GVHD。
结论
浅表结膜T细胞特征反映了同种异体HSCT患者对每日局部使用Ikervis滴眼液的依从性以及临床眼表参数。在最初12个月内，耐受性与其他局部用CsA制剂相当。
政府标识符
NCT04636918。网址：https://clinicaltrials.gov/ct2/show/NCT04636918?cond=ocular+Graft+Versus+Host+Disease&cntry=SG&draw=2&rank=2 。
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