再组合脱氧核糖核酶I眼药用于眼科移植与宿主疾病:随机临床试验结果
Christine S Mun1, Bayasgalan Surenkhuu, Yi-Fan Chen
1Corneal Translational Biology Laboratory (C.S.M., B.S., N.A., J.M., C.K., T.S., A.P., S.J.), Department of Ophthalmology and Visual Sciences; Center for Clinical and Translational Science (Y.-F.C.); and Department of Pharmacy Practice (M.A.S.), University of Illinois at Chicago, Chicago, IL.
Eye & contact lens
|February 26, 2024
概括
中性细胞外细胞陷 (NETs) 有助于眼科移植与宿主疾病 (oGVHD). DNAase眼滴安全降低了oGVHD的体征和症状,包括角膜染色和眼皮表面疾病指数得分,显示了初步的疗效.
科学领域:
- 眼科医生 眼科 眼科
- 免疫学 免疫学 免疫学
- 移植与宿主疾病的研究.
背景情况:
- 中性细胞外细胞陷 (NETs) 涉及到眼部表面炎症在眼部移植与宿主疾病 (oGVHD).
- 以前的研究表明,OGVHD患者的眼睛表面存在NETs.
研究的目的:
- 评估脱氧核酶I (DNAase) 眼滴在减少NET的安全性和初步疗效.
- 测试这样的假设,即眼皮表面NETs的减少将缓解oGVHD的体征和症状.
主要方法:
- 一个前性的,随机的,安慰剂控制的,双重掩盖的I/II期临床试验.
- 58名患有oGVHD的患者接受了DNAase (0.1%) 或车载眼滴每天四次,持续8周.
- 治疗意图分析评估了安全性 (耐受性,不良事件) 和疗效 (眼部表面疾病指数 (OSDI) 评分,角膜染色).
主要成果:
- 与车辆相比,DNAase眼滴与类似的不良事件相比,耐受性很好.
- 与基线相比,DNAase组观察到角膜染色和OSDI得分的显著减少.
- 在DNAase组中,主观总体评估的改善和粘液排泄的减少显著增加.
结论:
- DNAase眼滴是安全的,并且在治疗oGVHD时显示初步的疗效.
- 用DNAase眼滴减少眼睛表面NET可能会降低oGVHD的严重程度.
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