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蜂蜜眼用制剂治疗角膜溃疡患者的疗效:一项随机临床试验。

Efficacy of Honey-based Ophthalmic Formulation in Patients with Corneal Ulcer: A Randomized Clinical Trial.

机构信息

Poostchi Eye Research Center, Department of Ophthalmology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.

Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.

出版信息

Curr Drug Discov Technol. 2021;18(3):457-462. doi: 10.2174/1570163817666200214113055.

DOI:10.2174/1570163817666200214113055
PMID:32056528
Abstract

AIM

The aim of this study was to evaluate the efficacy of honey-based ophthalmic drop in patients with foreign body induced corneal ulcer.

BACKGROUND

Honey is traditionally used for skin, mucosal and corneal ulcers. Its use is well studied in human skin and mucosal ulcers and animal model of corneal ulcer with promising effects.

METHODS

In this randomized clinical trial, 50 patients with foreign body induced corneal ulcer were allocated to receive 70% sterile honey-based ophthalmic formulation or 0.3% ophthalmic ciprofloxacin, as the standard treatment every 6 hours. All the patients were examined for the size of corneal epithelial defect, corneal infiltration and depth and followed on a daily basis until complete healing. Duration for complete healing was considered as the outcome measure. Smear, culture, antibiogram and minimum inhibition concentration (MIC) tests were performed for honey and ciprofloxacin in all patients.

RESULTS

The average durations of complete healing of corneal epithelial defect in the honey and ciprofloxacin groups were 3.88 ± 3.44 vs. 6.32 ± 3.69days, respectively (p=0.020). No significant difference was observed between two groups regarding an average duration of healing of corneal infiltration (8.12 ±1.94 days vs. 8.64±2.15 days, p=0.375). MIC of honey for pseudomonas aeruginosa was 60%w/w, for E.Coli 40% w/w, and for staphylococcus aureus 30% w/w.

CONCLUSION

Honey based ophthalmic drop can acceleratethe corneal epithelial defect healing in patients with foreign body induced corneal ulcer, compared to ophthalmic ciprofloxacin as a standard treatment. The study was registered in Iranian registry of clinical trial center (IRCT) with registration number IRCT2015020120892N1.

摘要

目的

本研究旨在评估蜂蜜滴眼剂治疗外物性角膜溃疡的疗效。

背景

蜂蜜传统上用于治疗皮肤、黏膜和角膜溃疡。其在人类皮肤和黏膜溃疡以及角膜溃疡动物模型中的应用已有广泛研究,疗效令人鼓舞。

方法

在这项随机临床试验中,将 50 名外物性角膜溃疡患者分为两组,分别接受 70%无菌蜂蜜滴眼剂或 0.3%环丙沙星滴眼剂(作为标准治疗,每 6 小时 1 次)治疗。所有患者均接受角膜上皮缺损大小、角膜浸润及深度检查,并每天随访,直至完全愈合。将完全愈合所需的时间作为观察指标。对所有患者进行蜂蜜和环丙沙星的涂片、培养、药敏试验和最低抑菌浓度(MIC)检测。

结果

蜂蜜组和环丙沙星组角膜上皮缺损完全愈合的平均时间分别为 3.88 ± 3.44 天和 6.32 ± 3.69 天(p=0.020)。两组角膜浸润完全愈合的平均时间分别为 8.12 ± 1.94 天和 8.64± 2.15 天(p=0.375),差异无统计学意义。蜂蜜对铜绿假单胞菌的 MIC 为 60%w/w,对大肠杆菌的 MIC 为 40% w/w,对金黄色葡萄球菌的 MIC 为 30% w/w。

结论

与标准治疗药物环丙沙星相比,蜂蜜滴眼剂可加速外物性角膜溃疡患者的角膜上皮缺损愈合。本研究已在伊朗临床试验注册中心(IRCT)注册,注册号为 IRCT2015020120892N1。

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