Shanghai First People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Ophthalmology. 2013 Feb;120(2):355-61. doi: 10.1016/j.ophtha.2012.07.083. Epub 2012 Oct 18.
To describe an outbreak of intraocular inflammation caused by endotoxin-contaminated counterfeit bevacizumab in China.
Retrospective, observational case series.
Patients undergoing intravitreal injection at a public hospital in September 2010.
The medical records and microbiology results of patients who presented with intraocular inflammation after injection with intravitreal counterfeit bevacizumab were reviewed.
The incidence of intraocular inflammation, results of pathogen cultures, and clinical features of inflammation.
A total of 116 patients (70 men and 46 women) were injected from 3 vials of counterfeit bevacizumab. Intraocular inflammation developed in 80 patients. The estimated median incubation period was 12 hours (range, 2-24 hours), and the median duration of symptoms was 6 days (range, 3-22 days). All patients were treated initially with topical corticosteroid and antibiotics. Vitreous tap and intravitreal injection were performed on 43 patients. Twenty-one patients with hypopyon and significant vitreous inflammation underwent vitrectomy. Microscopic evaluations and microbiologic cultures of all ocular specimens were negative for bacterial and fungal contamination. The presence of endotoxin in specimens was confirmed by laboratory testing. We refer to this new clinical syndrome as "endotoxin-induced ocular toxic syndrome" (EOTS). The inflammation regressed rapidly after treatment, and 63 patients (78.8%) recovered their pre-injection vision.
This study implicates endotoxin as the cause of intraocular inflammation after the intravitreal injection of counterfeit bevacizumab. The EOTS appeared clinically distinct from typical infectious endophthalmitis.
描述中国一起由内毒素污染的假冒贝伐单抗引起的眼内炎症暴发。
回顾性、观察性病例系列研究。
2010 年 9 月在一家公立医院接受玻璃体腔注射的患者。
回顾了接受玻璃体腔注射假冒贝伐单抗后出现眼内炎症的患者的病历和微生物学结果。
眼内炎症的发生率、病原体培养结果和炎症的临床特征。
共有 116 名患者（70 名男性和 46 名女性）接受了来自 3 支假冒贝伐单抗的注射。80 名患者发生眼内炎症。估计的中位潜伏期为 12 小时（范围，2-24 小时），中位症状持续时间为 6 天（范围，3-22 天）。所有患者最初均接受局部皮质类固醇和抗生素治疗。对 43 名患者进行了玻璃体抽吸和玻璃体内注射。21 名有前房积脓和明显玻璃体炎症的患者接受了玻璃体切除术。所有眼部标本的显微镜评估和微生物培养均未发现细菌和真菌感染。通过实验室检测证实标本中存在内毒素。我们将这种新的临床综合征称为“内毒素诱导的眼毒性综合征（EOTS）”。炎症在治疗后迅速消退，63 名患者（78.8%）恢复了注射前的视力。
本研究提示内毒素是玻璃体腔注射假冒贝伐单抗后眼内炎症的原因。EOTS 与典型的感染性眼内炎在临床上有明显不同。
