Bandage Soft Contact Lenses for Ocular Graft-versus-Host Disease.
Bandage Soft Contact Lenses for Ocular Graft-versus-Host Disease.
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DOI：
10.1016/j.bbmt.2015.07.013
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发表时间：
2015-11
期刊：
影响因子：
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通讯作者：
Lee SJ
中科院分区：
文献类型：
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作者：
Inamoto Y;Sun YC;Flowers ME;Carpenter PA;Martin PJ;Li P;Wang R;Chai X;Storer BE;Shen TT;Lee SJ
为了检查绷带软性角膜接触镜（BSCL）治疗眼部慢性移植物抗宿主病（GVHD）的安全性和有效性，我们进行了一项II期临床试验。在每日局部抗生素预防下应用延长磨损BSCL。患者在入组时以及2周、4周和3个月后完成标准化症状问卷。在入组时、2周时和之后根据医学需要进行眼科评估。通过配对t检验将随访时的评估与基线进行比较。19例眼部GVHD患者，尽管进行了常规治疗，但仍有症状。入组时平均Lee眼子量表评分为75.4分，2周时显著改善至63.2分（p=0.01），4周时显著改善至61.8分（p=0.005），3个月时显著改善至56.3分（p=0.02）。眼表疾病指数评分和11分眼症状评分也显著改善。根据Lee眼子量表，在2周时观察到9例患者（47%）、4周时观察到11例患者（58%）和3个月时观察到9例患者（47%）有临床意义的改善。与入组值相比，2周时视力显著改善。根据2周时的裂隙灯检查，58%的患者点状上皮糜烂改善，16%稳定，5%恶化。无角膜溃疡和眼部感染发生。BSCL是一种广泛可用、安全有效的治疗选择，可改善约50%患者的眼部移植物抗宿主病表现。本研究在www.clinicaltrials.gov上注册为NCT 01616056。
To examine safety and efficacy of bandage soft contact lenses (BSCLs) for ocular chronic graft-versus host disease (GVHD), we conducted a phase II clinical trial. Extended-wear BSCLs were applied under daily topical antibiotics prophylaxis. Patients completed standardized symptom questionnaires at enrollment and at 2 weeks, 4 weeks and 3 months afterwards. Ophthalmologic assessment was performed at enrollment, at 2 weeks and afterwards as medically needed. Assessments at follow-up were compared with baseline by paired t-test. Nineteen patients with ocular GVHD who remained symptomatic despite conventional treatments were studied. The mean Lee eye subscale score was 75.4 at enrollment, and improved significantly to 63.2 at 2 weeks (p=0.01), to 61.8 at 4 weeks (p=0.005) and to 56.3 at 3 months (p=0.02). The ocular surface disease index score and 11-point eye symptom ratings also improved significantly. According to the Lee eye subscale, clinically meaningful improvement was observed in 9 patients (47%) at 2 weeks, in 11 (58%) at 4 weeks and in 9 (47%) at 3 months. Visual acuity improved significantly at 2 weeks compared with enrollment values. Based on slit lamp exam at 2 weeks, punctate epithelial erosions improved in 58% of the patients, showed stability in 16% and worsened in 5%. No corneal ulceration or ocular infection occurred. BSCLs are a widely available, safe and effective treatment option that improves manifestations of ocular graft-versus host disease in approximately 50% of patients. This study was registered at www.clinicaltrials.gov as NCT01616056.