纳他霉素和伏立康唑的体外药敏与真菌性角膜炎临床结局之间的关联
Association between in vitro susceptibility to natamycin and voriconazole and clinical outcomes in fungal keratitis.
作者信息
Sun Catherine Q, Lalitha Prajna, Prajna N Venkatesh, Karpagam Rajarathinam, Geetha Manoharan, O'Brien Kieran S, Oldenburg Catherine E, Ray Kathryn J, McLeod Stephen D, Acharya Nisha R, Lietman Thomas M
机构信息
F.I. Proctor Foundation, University of California, San Francisco, San Francisco, California.
Aravind Eye Care System, Madurai, India.
出版信息
Ophthalmology. 2014 Aug;121(8):1495-500.e1. doi: 10.1016/j.ophtha.2014.03.004. Epub 2014 Apr 16.
PURPOSE
To assess the association between minimum inhibitory concentration (MIC) and clinical outcomes in a fungal keratitis clinical trial.
DESIGN
Experimental study using data from a randomized comparative trial.
PARTICIPANTS
Of the 323 patients enrolled in the trial, we were able to obtain MIC values from 221 patients with monocular fungal keratitis.
METHODS
The Mycotic Ulcer Treatment Trial I was a randomized, double-masked clinical trial comparing clinical outcomes of monotherapy with topical natamycin versus voriconazole for the treatment of fungal keratitis. Speciation and determination of MIC to natamycin and voriconazole were performed according to Clinical and Laboratory Standards Institute guidelines. The relationship between MIC and clinical outcome was assessed.
MAIN OUTCOME MEASURES
The primary outcome was 3-month best spectacle-corrected visual acuity. Secondary outcomes included 3-month infiltrate or scar size; corneal perforation and/or therapeutic penetrating keratoplasty; and time to re-epithelialization.
RESULTS
A 2-fold increase in MIC was associated with a larger 3-month infiltrate or scar size (0.21 mm; 95% confidence interval [CI], 0.10-0.31; P < 0.001) and increased odds of perforation (odds ratio, 1.32; 95% CI, 1.04-1.69; P = 0.02). No correlation was found between MIC and 3-month visual acuity. For natamycin-treated cases, an association was found between higher natamycin MIC with larger 3-month infiltrate or scar size (0.29 mm; 95% CI, 0.15-0.43; P < 0.001) and increased perforations (odds ratio, 2.41; 95% CI, 1.46-3.97; P < 0.001). Among voriconazole-treated cases, the voriconazole MIC did not correlate with any of the measured outcomes in the study.
CONCLUSIONS
Decreased susceptibility to natamycin was associated with increased infiltrate or scar size and increased odds of perforation. There was no association between susceptibility to voriconazole and outcome.
目的
在一项真菌性角膜炎临床试验中评估最低抑菌浓度（MIC）与临床结局之间的关联。
设计
利用一项随机对照试验的数据进行的实验性研究。
参与者
在该试验纳入的323例患者中，我们能够获取221例单眼真菌性角膜炎患者的MIC值。
方法
真菌性溃疡治疗试验I是一项随机、双盲临床试验，比较局部使用那他霉素与伏立康唑单药治疗真菌性角膜炎的临床结局。根据临床和实验室标准协会指南进行菌种鉴定以及那他霉素和伏立康唑的MIC测定。评估MIC与临床结局之间的关系。
主要结局指标
主要结局为3个月时最佳矫正视力。次要结局包括3个月时浸润或瘢痕大小；角膜穿孔和/或治疗性穿透性角膜移植术；以及上皮化时间。
结果
MIC升高2倍与3个月时更大的浸润或瘢痕大小（0.21 mm；95%置信区间[CI]，0.10 - 0.31；P < 0.001）以及穿孔几率增加（优势比，1.32；95% CI，1.04 - 1.69；P = 0.02）相关。未发现MIC与3个月时的视力之间存在相关性。对于接受那他霉素治疗的病例，发现较高的那他霉素MIC与3个月时更大的浸润或瘢痕大小（0.29 mm；95% CI，0.15 - 0.43；P < 0.001）以及穿孔增加（优势比，2.41；95% CI，1.46 - 3.97；P < 0.001）相关。在接受伏立康唑治疗的病例中，伏立康唑MIC与研究中任何测量结局均无相关性。
结论
对那他霉素的敏感性降低与浸润或瘢痕大小增加以及穿孔几率增加相关。对伏立康唑的敏感性与结局之间无关联。
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