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随机临床试验:局部胰岛素与人工泪液治疗糖尿病患者玻璃体视网膜手术后医源性角膜上皮缺损愈合率的比较。

Randomized Clinical Trial of Topical Insulin Versus Artificial Tears for Healing Rates of Iatrogenic Corneal Epithelial Defects Induced During Vitreoretinal Surgery in Diabetics.

机构信息

Department of Ophthalmology, Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia, Kuala Lumpur, Wilayah Persekutuan, Malaysia; and.

Department of Pharmacy, Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia, Kuala Lumpur, Wilayah Persekutuan, Malaysia.

出版信息

Cornea. 2023 Nov 1;42(11):1395-1403. doi: 10.1097/ICO.0000000000003308. Epub 2023 May 17.

Abstract

PURPOSE

The aim of this study was to measure and compare the effect of topical insulin (0.5 units, 4 times per day) versus artificial tears (Vismed, sodium hyaluronate 0.18%, 4 times per day) for the healing of postoperative corneal epithelial defects induced during vitreoretinal surgery in diabetic patients.

METHODS

This is a double-blind randomized controlled hospital-based study involving diabetic patients with postoperative corneal epithelial defects after vitreoretinal surgery. Diabetic patients were randomized into 2 different groups and received either 0.5 units of topical insulin (DTI) or artificial tears (Vismed, sodium hyaluronate 0.18%; DAT). The primary outcome measured was the rate of corneal epithelial wound healing (mm 2 /h) over a preset interval and time from baseline to minimum size of epithelial defect on fluorescein-stained anterior segment digital camera photography. The secondary outcome measured was the safety of topical insulin 0.5 units and artificial tears (Vismed, sodium hyaluronate 0.18%). Patients were followed up until 3 months postoperation.

RESULTS

A total of 38 eyes from 38 patients undergoing intraoperative corneal debridement during vitreoretinal surgery with resultant epithelial defects (19 eyes per group) were analyzed. DTI was observed to have a significantly higher healing rate compared with the DAT group at rates over 36 hours ( P = 0.010), 48 hours ( P = 0.009), and 144 hours ( P = 0.009). The rate from baseline to closure was observed to be significantly higher in the DTI group (1.20 ± 0.29) (mm 2 /h) compared with the DAT group (0.78 ± 0.20) (mm 2 /h) as well ( P < 0.001). No adverse effect of topical insulin and artificial tears was reported.

CONCLUSIONS

Topical insulin (0.5 units, 4 times per day) is more effective compared with artificial tears (Vismed, sodium hyaluronate 0.18%, 4 times per day) for the healing of postoperative corneal epithelial defects induced during vitreoretinal surgery in diabetic patients, without any adverse events.

摘要

目的

本研究旨在测量和比较局部胰岛素(0.5 单位,每天 4 次)与人工泪液(Vismed,透明质酸钠 0.18%,每天 4 次)在治疗糖尿病患者玻璃体视网膜手术后引起的术后角膜上皮缺损的效果。

方法

这是一项基于医院的双盲随机对照研究,涉及玻璃体视网膜手术后出现术后角膜上皮缺损的糖尿病患者。糖尿病患者被随机分为 2 组,分别接受 0.5 单位的局部胰岛素(DTI)或人工泪液(Vismed,透明质酸钠 0.18%;DAT)。主要测量指标为预设时间间隔内角膜上皮愈合率(mm 2 /h),以及从基线到荧光素染色前节数字摄影术上皮缺损最小尺寸的时间。次要测量指标为局部胰岛素 0.5 单位和人工泪液(Vismed,透明质酸钠 0.18%)的安全性。患者随访至术后 3 个月。

结果

共分析了 38 例(每组 19 例)在玻璃体视网膜手术中进行术中角膜清创术并导致上皮缺损的患者的 38 只眼。与 DAT 组相比,DTI 在 36 小时(P=0.010)、48 小时(P=0.009)和 144 小时(P=0.009)时具有更高的愈合率。在 DTI 组中,从基线到闭合的速度明显高于 DAT 组(1.20±0.29)(mm 2 /h)(P<0.001)。未报告局部胰岛素和人工泪液的不良反应。

结论

与人工泪液(Vismed,透明质酸钠 0.18%,每天 4 次)相比,局部胰岛素(0.5 单位,每天 4 次)在治疗糖尿病患者玻璃体视网膜手术后引起的术后角膜上皮缺损方面更有效,且无不良反应。

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