Department of Ophthalmology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
Cornea. 2013 Aug;32(8):1116-9. doi: 10.1097/ICO.0b013e3182910036.
To evaluate the sterility and safety of 100% nonpreserved, autologous, serum eye drop treatment in patients with ocular surface diseases.
A total of 147 autologous serum bottles (294 samples) from 21 patients with ocular surface diseases were included. Seven bottles with autologous serum were prepared for each patient, and each bottle was used for only 1 day, then discarded. Two samples from each bottle were taken (before use and after 24 hours of use) and then cultured in standard media. The culture plates were held for at least 6 weeks or until no growth could be confirmed. To monitor safety, all patients were admitted and evaluated for the occurrence of infection.
In the pretreatment group, 4 samples from 4 patients (1.36%) were positive for bacteria and 7 samples from 7 patients (2.38%) were positive for fungi. In the 24-hour-after-treatment group, 1 culture (0.34%) was positive for bacteria, and 6 samples (2.04%) from 6 patients were positive for fungi. Aspergillus spp and Fonsecaea spp were the most common organisms identified in any of the cultures. Neither clinical nor microbiological evidence of infection was demonstrated in any patient during the treatment or follow-up periods.
Although no ocular surface infection was observed, the patients under 100% autologous serum eye drops therapy should be closely monitored for clinical evidence of fungal and bacterial infections.
评估 100% 未保存的、自体、血清滴眼剂治疗眼表疾病患者的无菌性和安全性。
纳入 21 例眼表疾病患者的 147 瓶（294 份）自体血清。每位患者制备 7 瓶自体血清，每瓶仅使用 1 天，然后丢弃。从每个瓶中取 2 个样本（使用前和使用 24 小时后），然后在标准培养基中培养。培养板保持至少 6 周或直到确认无生长。为了监测安全性，所有患者均入院并评估感染发生情况。
在预处理组中，4 名患者（1.36%）的 4 份样本细菌培养阳性，7 名患者（2.38%）的 7 份样本真菌培养阳性。在治疗 24 小时后组中，1 份培养物（0.34%）细菌培养阳性，6 名患者（2.04%）的 6 份样本真菌培养阳性。在任何培养物中，最常见的分离物为曲霉菌属和绵霉属。在治疗和随访期间，任何患者均未出现临床或微生物学证据的感染。
尽管未观察到眼表感染，但接受 100%自体血清滴眼剂治疗的患者应密切监测真菌和细菌感染的临床证据。
