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3% 地夸磷索眼用溶液对白内障术后干眼患者的临床疗效及安全性:一项随机对照试验

Clinical Effects and Safety of 3% Diquafosol Ophthalmic Solution for Patients With Dry Eye After Cataract Surgery: A Randomized Controlled Trial.

作者信息

Park Dae Hyun, Chung Jin Kwon, Seo Du Ri, Lee Sung Jin

机构信息

Department of Ophthalmology, Soonchunhyang University College of Medicine, Soonchunhyang University Hospital, Seoul, South Korea.

Department of Ophthalmology, Soonchunhyang University College of Medicine, Soonchunhyang University Hospital, Seoul, South Korea.

出版信息

Am J Ophthalmol. 2016 Mar;163:122-131.e2. doi: 10.1016/j.ajo.2015.12.002. Epub 2015 Dec 11.

Abstract

PURPOSE

To compare the efficacies and safety profiles of 3% diquafosol and 0.1% sodium hyaluronate in patients with dry eye after cataract surgery.

DESIGN

Randomized controlled trial.

METHODS

setting: Soonchunhyang University Hospital, Seoul, South Korea.

STUDY POPULATION

In all, 130 eyes of 86 dry eye patients who had undergone cataract surgery between January 2014 and January 2015 were enrolled and randomly divided into a diquafosol group and a sodium hyaluronate group.

INTERVENTION

The diquafosol group used diquafosol 6 times a day and the hyaluronate group used sodium hyaluronate 6 times a day after cataract surgery.

MAIN OUTCOME MEASURES

Evaluations of efficacy were conducted based on an Ocular Surface Disease Index questionnaire, tear breakup time (TBUT), Schirmer I test, corneal fluorescein and conjunctival lissamine green staining scores, serial measurement of ocular higher-order aberrations (HOAs), corneal HOAs, and uncorrected distance visual acuity test. Safety evaluations were based on anterior chamber inflammation and discontinuation of the eye drops.

RESULTS

Objective signs and subjective symptoms were aggravated at 1 week postoperatively and began to recover significantly 4 weeks after surgery. The diquafosol group showed significantly superior TBUT (P < .001), corneal fluorescein (P = .045), and conjunctival staining (P = .001) compared to the sodium hyaluronate group throughout the study period. TBUT (P < .001) and the change in HOAs (P = .018) recovered significantly more quickly in the diquafosol group. The safety evaluations showed no intergroup differences.

CONCLUSIONS

Eye drops of 3% diquafosol may be an effective and safe treatment for the management of cataract surgery-induced dry eye aggravation in patients with preexisting dry eye.

摘要

目的

比较3%地夸磷索钠和0.1%透明质酸钠对白内障术后干眼患者的疗效和安全性。

设计

随机对照试验。

方法

地点:韩国首尔顺天乡大学医院。

研究对象

2014年1月至2015年1月期间接受白内障手术的86例干眼患者的130只眼被纳入研究,并随机分为地夸磷索钠组和透明质酸钠组。

干预措施

地夸磷索钠组在白内障术后每天使用地夸磷索钠6次,透明质酸钠组每天使用透明质酸钠6次。

主要观察指标

基于眼表疾病指数问卷、泪膜破裂时间(TBUT)、泪液分泌试验、角膜荧光素和结膜丽丝胺绿染色评分、眼部高阶像差(HOAs)的系列测量、角膜HOAs以及未矫正远视力测试进行疗效评估。安全性评估基于前房炎症和滴眼液停用情况。

结果

术后1周客观体征和主观症状加重,术后4周开始明显恢复。在整个研究期间,地夸磷索钠组的TBUT(P <.001)、角膜荧光素(P =.045)和结膜染色(P =.001)明显优于透明质酸钠组。地夸磷索钠组的TBUT(P <.001)和HOAs变化(P =.018)恢复得明显更快。安全性评估显示两组间无差异。

结论

3%地夸磷索钠滴眼液可能是治疗已有干眼的患者白内障手术引起的干眼加重的一种有效且安全的方法。

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