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韩国白内障手术后真菌性眼内炎的暴发。

An Outbreak of Fungal Endophthalmitis After Cataract Surgery in South Korea.

机构信息

Department of Ophthalmology, Korea University Guro Hospital, Seoul, Korea.

Kim's Eye Hospital, Seoul, Korea.

出版信息

JAMA Ophthalmol. 2023 Mar 1;141(3):226-233. doi: 10.1001/jamaophthalmol.2022.5927.

Abstract

IMPORTANCE

Fungal endophthalmitis caused by contaminated medical products is extremely rare; it follows an intractable clinical course with a poor visual prognosis.

OBJECTIVE

To report the epidemiologic and clinical features and treatment outcomes of a nationwide fungal endophthalmitis outbreak after cataract surgery as a result of contaminated viscoelastic agents in South Korea.

DESIGN, SETTING, AND PARTICIPANTS: This was a retrospective case series analysis of clinical data from multiple institutions in South Korea conducted from September 1, 2020, to October 31, 2021. Data were collected through nationwide surveys in May and October 2021 from the 100 members of the Korean Retinal Society. Patients were diagnosed with fungal endophthalmitis resulting from the use of the viscoelastic material sodium hyaluronate (Unial [Unimed Pharmaceutical Inc]). Data were analyzed from November 1, 2021, to May 30, 2022.

MAIN OUTCOMES AND MEASURES

The clinical features and causative species were identified, and treatment outcomes were analyzed for patients who underwent 6 months of follow-up.

RESULTS

The fungal endophthalmitis outbreak developed between September 1, 2020, and June 30, 2021, and peaked in November 2020. An official investigation by the Korea Disease Control and Prevention Agency confirmed contamination of viscoelastic material. All 281 eyes of 265 patients (mean [SD] age, 65.4 [10.8] years; 153 female individuals [57.7%]) were diagnosed with fungal endophthalmitis, based on clinical examinations and supportive culture results. The mean (SD) time period between cataract surgery and diagnosis was 24.7 (17.3) days. Patients exhibited characteristic clinical features of fungal endophthalmitis, including vitreous opacity (212 of 281 [75.4%]), infiltration into the intraocular lens (143 of 281 [50.9%]), and ciliary infiltration (55 of 281 [19.6%]). Cultures were performed in 260 eyes, and fungal presence was confirmed in 103 eyes (39.6%). Among them, Fusarium species were identified in 89 eyes (86.4%). Among the 228 eyes included in the treatment outcome analysis, the mean (SD) best-corrected visual acuity improved from 0.78 (0.74) logMAR (Snellen equivalent, 20/120 [7.3 lines]) to 0.36 (0.49) logMAR (Snellen equivalent, 20/45 [4.9 lines]) at 6 months. Furthermore, disease remission with no signs of fungal endophthalmitis (or cells in the anterior chamber milder than grade 1) was noted in 214 eyes (93.9%).

CONCLUSIONS AND RELEVANCE

This was a retrospectively reviewed case series of a fungal endophthalmitis outbreak resulting from contaminated viscoelastic material. Findings of this case series study support the potential benefit of prompt, aggressive surgical intervention that may reduce treatment burden and improve prognosis of fungal endophthalmitis caused by contaminated medical products.

摘要

重要性

由污染的医疗产品引起的真菌性眼内炎极为罕见;它具有难治的临床病程和较差的视觉预后。

目的

报告韩国白内障手术后由于粘性剂污染导致的全国性真菌性眼内炎爆发的流行病学和临床特征以及治疗结果。

设计、设置和参与者:这是一项对 2020 年 9 月 1 日至 2021 年 10 月 31 日期间来自韩国多个机构的临床数据进行的回顾性病例系列分析。数据通过 2021 年 5 月和 10 月对韩国视网膜学会的 100 名成员进行的全国性调查收集。患者被诊断为使用粘性材料透明质酸钠(Unial [Unimed Pharmaceutical Inc])引起的真菌性眼内炎。数据分析于 2021 年 11 月 1 日至 2022 年 5 月 30 日进行。

主要结果和措施

确定了临床特征和致病物种,并分析了接受 6 个月随访的患者的治疗结果。

结果

真菌性眼内炎爆发发生在 2020 年 9 月 1 日至 2021 年 6 月 30 日之间,并在 2020 年 11 月达到高峰。韩国疾病控制和预防局的一项官方调查证实了粘性材料的污染。根据临床检查和支持性培养结果,265 名患者的 281 只眼中(平均[标准差]年龄,65.4[10.8]岁;153 名女性[57.7%])被诊断为真菌性眼内炎。白内障手术后至诊断的平均(标准差)时间为 24.7(17.3)天。患者表现出真菌性眼内炎的典型临床特征,包括玻璃体混浊(212 只眼[75.4%])、眼内晶状体浸润(143 只眼[50.9%])和睫状体浸润(55 只眼[19.6%])。对 260 只眼进行了培养,在 103 只眼中证实了真菌的存在(39.6%)。其中,89 只眼(86.4%)鉴定为镰刀菌属。在包括 228 只眼的治疗结果分析中,最佳矫正视力从 0.78(0.74)logMAR(Snellen 等价物,20/120 [7.3 行])改善至 0.36(0.49)logMAR(Snellen 等价物,20/45 [4.9 行])在 6 个月时。此外,214 只眼(93.9%)观察到疾病缓解,无真菌性眼内炎迹象(或前房细胞轻度至 1 级)。

结论和相关性

这是一项回顾性病例系列研究,研究了由污染的粘性材料引起的真菌性眼内炎爆发。本病例系列研究的结果支持及时、积极的手术干预的潜在益处,这可能减轻治疗负担并改善受污染医疗产品引起的真菌性眼内炎的预后。

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