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.
Cornea. 2019 Oct;38(10):1314-1321. doi: 10.1097/ICO.0000000000002068.
To evaluate a new corneal cold storage medium including an antimycotic tablet (Kerasave, AL.CHI.MI.A. S.r.l.).
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.
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.
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.
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.）。
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。
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。
在存在和不存在角膜组织的情况下，Kerasave 在 4°C 时对敏感真菌株显示出高抗真菌功效。Kerasave 未消除对两性霉素 B 耐药的菌株。Kerasave 无细胞毒性、刺激性或致敏性。
