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羟丙甲纤维素眼用植入剂(泪然)治疗干眼综合征患者亚组的疗效:患者登记研究的结果。

Efficacy of hydroxypropyl cellulose ophthalmic inserts (LACRISERT) in subsets of patients with dry eye syndrome: findings from a patient registry.

机构信息

South Shore Eye Care, Wantagh, NY 11566, USA.

出版信息

Cornea. 2010 Dec;29(12):1417-27. doi: 10.1097/ICO.0b013e3181e3f05b.

Abstract

PURPOSE

To determine acceptability and efficacy of hydroxypropyl cellulose ophthalmic inserts in patients with dry eye syndrome (DES) and additional comorbidities.

DESIGN

A multicenter, 2-visit, open-label, 4-week registry study.

PARTICIPANTS

Five hundred twenty patients were recruited to the intent-to-treat group. Four hundred eighteen patients completed the study including 86 contact lens wearers, 79 with cataract diagnosis, 52 with prior cataract surgery, 22 with prior laser-assisted in situ keratomileusis, and 15 with glaucoma.

METHODS

Patient questionnaires were completed at baseline and after 4 weeks of treatment to assess mean change in severity of DES symptoms, ocular surface disease index (OSDI) scores, frequency of occurrence of DES symptoms, occurrence of difficulty when performing activities of daily living (ADLs), and frequency of discomfort in various environmental conditions. Mean change was measured from visit 1 to visit 2.

MAIN OUTCOME MEASURES

Symptoms, OSDI scores, and measure of degree of difficulty when performing ADLs.

RESULTS

Four hundred eighteen patients completed the study. Compared with baseline, this population of patients demonstrated statistically significant improvements in mean OSDI scores (P = 0.0215) and symptoms of discomfort, burning, dryness, grittiness, stinging, and light sensitivity (P < 0.05). Mean improvement in OSDI scores of patients in the 5 identified subsets of patients with comorbid conditions were significant for patients using contact lenses (P < 0.025), who had undergone prior cataract surgery (P < 0.04), and with prior laser-assisted in situ keratomileusis surgery (P < 0.05). Patients diagnosed with cataracts or glaucoma did not show significant changes in any measures in this study. Patients with DES and comorbid conditions experienced relief of symptoms and benefit to ADLs and quality of life similar to patients without comorbid conditions.

CONCLUSIONS

In subsets of patients with moderate to severe DES and comorbid conditions, hydroxypropyl cellulose ophthalmic inserts improve the symptoms of DES, ability to perform ADLs, and quality of life. The reported benefits may be additive to those seen with patients' existing therapies.

摘要

目的

评估羟丙甲纤维素眼用植入剂治疗伴有其他合并症的干眼综合征(DES)患者的安全性和疗效。

设计

多中心、双次就诊、开放性、4 周注册研究。

参与者

共有 520 例患者被纳入意向治疗组。418 例患者完成了研究,其中包括 86 名隐形眼镜佩戴者、79 名白内障诊断患者、52 名白内障手术史患者、22 名激光辅助原位角膜磨镶术史患者和 15 名青光眼患者。

方法

患者在基线时和治疗 4 周后完成问卷调查,以评估 DES 症状严重程度、眼表疾病指数(OSDI)评分、DES 症状发生频率、日常生活活动(ADL)执行困难程度以及各种环境条件下不适频率的平均变化。从就诊 1 到就诊 2 测量平均变化。

主要观察指标

症状、OSDI 评分和 ADL 执行困难程度的衡量标准。

结果

418 例患者完成了研究。与基线相比,该患者人群的 OSDI 评分(P=0.0215)和不适、烧灼感、干燥感、磨砂感、刺痛感和畏光感等症状有统计学意义的改善(P<0.05)。在 5 个有合并症患者亚组中,戴隐形眼镜的患者(P<0.025)、接受过白内障手术的患者(P<0.04)和接受过激光辅助原位角膜磨镶术的患者(P<0.05)的 OSDI 评分平均改善有统计学意义。患有白内障或青光眼的患者在本研究中没有任何指标的显著变化。患有 DES 和合并症的患者在症状缓解、ADL 获益和生活质量方面与无合并症患者相似。

结论

在伴有中重度 DES 和合并症的患者亚组中,羟丙甲纤维素眼用植入剂可改善 DES 症状、ADL 能力和生活质量。报告的益处可能与患者现有治疗的益处相加。

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