Comparison of natamycin and voriconazole for the treatment of fungal keratitis.
Comparison of natamycin and voriconazole for the treatment of fungal keratitis.
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DOI：
10.1001/archophthalmol.2010.102
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发表时间：
2010-06
影响因子：
--
通讯作者：
Acharya, Nisha R.
中科院分区：
文献类型：
--
作者：
Prajna, Namperumalsamy V.;Mascarenhas, Jeena;Krishnan, Tiruvengada;Reddy, P. Ravindranath;Prajna, Lalitha;Srinivasan, Muthiah;Vaitilingam, C. M.;Hong, Kevin C.;Lee, Salena M.;McLeod, Stephen D.;Zegans, Michael E.;Porco, Travis C.;Lietman, Thomas M.;Acharya, Nisha R.
进行一项治疗探索性临床试验，比较局部纳他霉素与局部伏立康唑治疗真菌性角膜炎的临床结局。这项多中心、双盲、临床试验包括印度Aravind眼科医院的120名真菌性角膜炎患者，他们被随机分配接受局部纳他霉素或局部伏立康唑治疗，并反复刮除上皮或不刮除上皮。主要结局是3个月时的最佳视力矫正视力（BSCVA）。其他结局包括瘢痕大小、穿孔和入组视力为20/40至20/400的患者3个月时BSCVA的亚组分析。与接受那他霉素治疗的患者相比，伏立康唑治疗的患者在多变量回归模型中调整刮擦后3个月的BSCVA改善约1行，但差异无统计学意义（P= 0.29）。调整刮擦后，伏立康唑组3个月时的瘢痕大小略大（P=.48）。伏立康唑组的角膜穿孔（10/60例）与纳他霉素治疗组（9/60例）无显著差异（P> 0.99）。在调整药物后3个月，刮擦与BSCVA恶化相关（P= 0.06）。基线BSCVA为20/40至20/400的患者显示伏立康唑组视力有2线改善的趋势（P=.07）。总体而言，伏立康唑和纳他霉素治疗的患者在视力、瘢痕大小和穿孔方面没有显著差异。有一种趋势是刮擦与更糟糕的结果相关。伏立康唑在基线视力为20/40至20/400的患者亚组中观察到的获益需要在确证性临床试验中进行验证。clinicaltrials.gov标识符：NCT 00557362
To conduct a therapeutic exploratory clinical trial comparing clinical outcomes of treatment with topical natamycin vs topical voriconazole for fungal keratitis. The multicenter, double-masked, clinical trial included 120 patients with fungal keratitis at Aravind Eye Hospital in India who were randomized to receive either topical natamycin or topical voriconazole and either had repeated scraping of the epithelium or not. The primary outcome was best spectacle-corrected visual acuity (BSCVA) at 3 months. Other outcomes included scar size, perforations, and a sub-analysis of BSCVA at 3 months in patients with an enrollment visual acuity of 20/40 to 20/400. Compared with those who received natamycin, voriconazole-treated patients had an approximately 1-line improvement in BSCVA at 3 months after adjusting for scraping in a multivariate regression model but the difference was not statistically significant (P=.29). Scar size at 3 months was slightly greater with voriconazole after adjusting for scraping (P=.48). Corneal perforations in the voriconazole group (10 of 60 patients) were not significantly different than in the natamycin-treated group (9 of 60 patients) (P>.99). Scraping was associated with worse BSCVA at 3 months after adjusting for drug (P=.06). Patients with baseline BSCVA of 20/40 to 20/400 showed a trend toward a 2-line improvement in visual acuity with voriconazole (P=.07). Overall, there were no significant differences in visual acuity, scar size, and perforations between voriconazole- and natamycin-treated patients. There was a trend toward scraping being associated with worse outcomes. The benefit seen with voriconazole in the subgroup of patients with baseline visual acuity of 20/40 to 20/400 needs to be validated in a confirmatory clinical trial. clinicaltrials.gov Identifier: NCT00557362
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