Esen K Akpek, John D Sheppard, Adam Hamm, Simone Angstmann-Mehr, Sonja Krösser
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引用次数: 0
摘要
这是对两项 III 期临床试验的汇总分析,研究了治疗中重度干眼症的无水外用环孢素 0.1%。分析对象包括 1162 名患者:其中 35% 患有白内障,20% 患有假性角膜病,45% 未患白内障。除年龄和视力外,各组的人口统计学或基线特征具有可比性。接受环孢素治疗的患者在第15天时的平均视力与基线相比有很大提高:无白内障患者为-3.7,白内障患者为-3.2,假性白内障患者为-3.1。与相应的药物组相比,这些改善在统计学上明显更高。在白内障亚组中,59%接受环孢素治疗的患者的角膜染色评分早在第15天就得到了≥3级的改善。这种新型环孢素溶液疗效显著、起效早,有望成为白内障手术患者术前眼表治疗的候选药物。
Efficacy of a new water-free topical cyclosporine 0.1% solution for optimizing the ocular surface in patients with dry eye and cataract.
This is a pooled analysis from 2 phase III clinical trials investigating a water-free topical cyclosporine 0.1% for the treatment of moderate to severe dry eye. The analyses included 1162 patients: 35% with cataract, 20% with pseudophakia, and 45% without cataract. Demographics or baseline characteristics were comparable across groups except for age and vision. The cyclosporine-treated patients achieved large mean improvements from baseline by day 15: -3.7 in patients without cataract, -3.2 in patients with cataract, and -3.1 in pseudophakic patients. These improvements were statistically significantly higher compared with the respective vehicle groups. In the cataract subgroup, 59% of patients treated with cyclosporine achieved ≥3 grade improvements in corneal staining score, as early as day 15. The magnitude of the effect and early onset of action make this new cyclosporine solution a promising candidate for preoperative management of ocular surface in patients undergoing cataract surgery.
期刊介绍:
The Journal of Cataract & Refractive Surgery (JCRS), a preeminent peer-reviewed monthly ophthalmology publication, is the official journal of the American Society of Cataract and Refractive Surgery (ASCRS) and the European Society of Cataract and Refractive Surgeons (ESCRS).
JCRS publishes high quality articles on all aspects of anterior segment surgery. In addition to original clinical studies, the journal features a consultation section, practical techniques, important cases, and reviews as well as basic science articles.