新型冷藏角膜保存介质的时间杀菌和毒性研究的抗真菌效果和安全性。

Antimycotic Efficacy and Safety of a New Cold Corneal Storage Medium by Time-Kill and Toxicity Studies.

机构信息

Alchilife S.r.l., Ponte San Nicolò, Italy.

Ophthalmic Biophysics Center Bascom Palmer Eye Institute (BPEI), University of Miami Miller School of Medicine, Miami, FL.

出版信息

Cornea. 2019 Oct;38(10):1314-1321. doi: 10.1097/ICO.0000000000002068.

DOI:10.1097/ICO.0000000000002068

PMID:31335527

Abstract

PURPOSE

To evaluate a new corneal cold storage medium including an antimycotic tablet (Kerasave, AL.CHI.MI.A. S.r.l.).

METHODS

Kerasave and tryptone soy broth (control) were inoculated with 10 and 10 colony-forming units (CFU)/mL of 6 Candida isolates (Candida albicans [n = 4], Candida tropicalis [n = 1], and Candida glabrata [n = 1]). Minimum inhibitory concentrations (MICs) were determined using amphotericin B Etest strips. Sterile porcine corneas contaminated with 10 CFU/mL of each isolate were incubated in Kerasave and control at 4°C. Growth rate and Log10 reduction at 4°C at different time intervals were determined for liquid samples and tissue homogenates. Kerasave biocompatibility was assessed according to ISO 10993-5 and ISO 10993-10.

RESULTS

No C. albicans or C. tropicalis colonies were recovered from Kerasave inoculated with 10 CFU/mL after incubation for 3 days at 4°C. C. glabrata was inhibited but not killed after 3 days at 4°C. Four of the 6 strains contaminated with 10 CFU/mL demonstrated a significant ≥ 3 Log10 reduction in media and tissue homogenates within 5 days as compared to controls (p < 0.01). Amphotericin B MICs ranged from 0.19 to 0.38 μg/mL for C. albicans (n = 3) and C. tropicalis (n = 1). C. glabrata showed reduced susceptibility (0.5 μg/mL) and 1 C. albicans was resistant to amphotericin B (≥ 1 μg/mL). Kerasave was not cytotoxic, irritating, or sensitizing according to the ISO standards.

CONCLUSIONS

Kerasave showed high antifungal efficacy against susceptible fungal strains at 4°C in the presence and absence of corneal tissue. Resistant strains to amphotericin B were not eliminated by Kerasave. Kerasave is not cytotoxic, irritating, or sensitizing.

摘要

目的

评估一种新型角膜冷藏液，其中包含一种抗真菌片剂（Kerasave，AL.CHI.MI.A. S.r.l.）。

方法

将 Kerasave 和胰蛋白胨大豆肉汤（对照）分别接种 10 和 10 个菌落形成单位（CFU）/mL 的 6 株念珠菌分离株（白色念珠菌[4 株]、热带念珠菌[1 株]和光滑念珠菌[1 株]）。使用两性霉素 B Etest 条确定最小抑菌浓度（MIC）。将 10 CFU/mL 的每个分离株污染的无菌猪角膜在 4°C 下孵育于 Kerasave 和对照中。在不同时间间隔测定液体样本和组织匀浆中的 4°C 下的生长速度和 Log10 减少。根据 ISO 10993-5 和 ISO 10993-10 评估 Kerasave 的生物相容性。

结果

在 4°C 孵育 3 天后，从接种 10 CFU/mL 的 Kerasave 中未回收任何白色念珠菌或热带念珠菌菌落。4°C 孵育 3 天后，光滑念珠菌被抑制但未被杀死。与对照相比，6 株污染 10 CFU/mL 的菌株中有 4 株在 5 天内显示出显著的≥3 Log10 减少（p < 0.01）。白色念珠菌（n = 3）和热带念珠菌（n = 1）的两性霉素 B MIC 范围为 0.19 至 0.38 μg/mL。光滑念珠菌显示出较低的敏感性（0.5 μg/mL），1 株白色念珠菌对两性霉素 B 耐药（≥1 μg/mL）。根据 ISO 标准，Kerasave 无细胞毒性、刺激性或致敏性。