The mycotic ulcer treatment trial: a randomized trial comparing natamycin vs voriconazole.
The mycotic ulcer treatment trial: a randomized trial comparing natamycin vs voriconazole.
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DOI：
10.1001/jamaophthalmol.2013.1497
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发表时间：
2013-04
影响因子：
8.1
通讯作者：
Lietman, Thomas M.
中科院分区：
文献类型：
--
作者：
Prajna, N. Venkatesh;Krishnan, Tiruvengada;Mascarenhas, Jeena;Rajaraman, Revathi;Prajna, Lalitha;Srinivasan, Muthiah;Raghavan, Anita;Oldenburg, Catherine E.;Ray, Kathryn J.;Zegans, Michael E.;McLeod, Stephen D.;Porco, Travis C.;Acharya, Nisha R.;Lietman, Thomas M.
比较纳他霉素与伏立康唑治疗丝状真菌性角膜炎的疗效。这项3期、双盲、多中心试验设计将368名患者随机分配到伏立康唑（1%）或纳他霉素（5%）组，醒着时每小时局部应用一次，直到上皮再生，然后每天4次，持续至少3周。入选条件包括涂片阳性丝状真菌溃疡和视力在20/40至20/400之间。主要结果为3个月时最佳眼镜矫正视力；次要结果包括角膜穿孔和/或治疗性穿透性角膜移植术。共有940名患者接受了筛查，323名患者入组。致病菌包括镰刀菌（128例[40%]）、曲霉菌（54例[17%]）和其他丝状真菌（141例[43%]）。纳他霉素治疗组3个月最佳眼镜矫正视力明显优于伏立康唑治疗组（回归系数= - 0.18 logMAR; 95% CI, - 0.30 ~ - 0.05； P= 0.006）。纳他霉素治疗的病例发生穿孔或需要治疗性穿透性角膜移植术的可能性较小（优势比=0.42;95% CI， 0.22至0.80；P= 0.009）。镰刀菌感染患者纳他霉素治疗效果优于伏立康唑治疗（回归系数= - 0.41 logMAR， 95% CI为- 0.61至- 0.20，P< 0.001；穿孔的优势比=0.06,95% CI为0.01至0.28，P< 0.001），非镰刀菌感染患者的效果相似（回归系数= - 0.02 logMAR， 95% CI为- 0.17至0.13，P= 0.81；穿孔的优势比=1.08,95% CI为0.48至2.43，P= 0.86）。对于涂片阳性丝状真菌性角膜炎，纳他霉素治疗的临床和微生物学结果明显优于伏立康唑治疗，其中大部分差异可归因于镰刀菌病例的改善结果。伏立康唑不应用于丝状角膜炎的单药治疗。clinicaltrials.gov标识符：NCT00996736
To compare topical natamycin vs voriconazole in the treatment of filamentous fungal keratitis. This phase 3, double-masked, multicenter trial was designed to randomize 368 patients to voriconazole (1%) or natamycin (5%), applied topically every hour while awake until reepithelialization, then 4 times daily for at least 3 weeks. Eligibility included smear-positive filamentous fungal ulcer and visual acuity of 20/40 to 20/400. The primary outcome was best spectacle-corrected visual acuity at 3 months; secondary outcomes included corneal perforation and/or therapeutic penetrating keratoplasty. A total of 940 patients were screened and 323 were enrolled. Causative organisms included Fusarium (128 patients [40%]), Aspergillus (54 patients [17%]), and other filamentous fungi (141 patients [43%]). Natamycin-treated cases had significantly better 3-month best spectacle-corrected visual acuity than voriconazole-treated cases (regression coefficient=−0.18 logMAR; 95% CI, −0.30 to −0.05; P=.006). Natamycin-treated cases were less likely to have perforation or require therapeutic penetrating keratoplasty (odds ratio=0.42; 95% CI, 0.22 to 0.80; P=.009). Fusarium cases fared better with natamycin than with voriconazole (regression coefficient=−0.41 logMAR; 95% CI, −0.61 to −0.20; P<.001; odds ratio for perforation=0.06; 95% CI, 0.01 to 0.28; P<.001), while non-Fusarium cases fared similarly (regression coefficient=−0.02 logMAR; 95% CI, −0.17 to 0.13; P=.81; odds ratio for perforation=1.08; 95% CI, 0.48 to 2.43; P=.86). Natamycin treatment was associated with significantly better clinical and microbiological outcomes than voriconazole treatment for smear-positive filamentous fungal keratitis, with much of the difference attributable to improved results in Fusarium cases. Voriconazole should not be used as monotherapy in filamentous keratitis. clinicaltrials.gov Identifier: NCT00996736
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DOI：
10.1136/bjo.2009.169607
发表时间：
2011-06
期刊：
The British journal of ophthalmology
影响因子：
--
作者：
Shah A;Sachdev A;Coggon D;Hossain P
通讯作者：
Hossain P
影响因子：
120.7
作者：
Chang, Douglas C.;Grant, Gavin B.;Park, Benjamin J.
通讯作者：
Park, Benjamin J.
影响因子：
3.7
作者：
Ibrahim, Marlon Moraes;de Angelis, Rafael;Rocha, Eduardo Melani
通讯作者：
Rocha, Eduardo Melani
影响因子：
--
作者：
Bernal, Maria D.;Acharya, Nisha R.;Hwang, David G.
通讯作者：
Hwang, David G.
影响因子：
--
作者：
Lalitha, Prajna;Shapiro, Brett L.;Lietman, Thomas M.
通讯作者：
Lietman, Thomas M.