Uddaraju Madhu, Mascarenhas Jeena, Das Mano Ranjan, Radhakrishnan Naveen, Keenan Jeremy D, Prajna Lalitha, Prajna Venkatesh N
Aravind Eye Hospital, Madurai, Tamilnadu, India.
Francis I. Proctor Foundation and Department of Ophthalmology, University of California, San Francisco, San Francisco, California.
Am J Ophthalmol. 2015 Jul;160(1):131-4.e5. doi: 10.1016/j.ajo.2015.03.024. Epub 2015 Apr 1.
To assess the efficacy of corneal cross-linking (CXL) as an adjuvant to appropriate antifungal therapy in nonresolving deep stromal fungal keratitis.
Randomized clinical trial.
Eyes with culture-positive deep stromal fungal keratitis not responding to appropriate medical therapy for a period of 2 weeks were randomized to receive either adjuvant CXL or no additional treatment. Antifungal medical therapy was continued in both groups. The prespecified primary outcome was treatment failure at 6 weeks after enrollment, defined as perforation and/or increase in ulcer size by ≥2 mm.
The trial was stopped before full enrollment because of a marked difference in the rate of perforation between the 2 groups. Of the 13 cases enrolled in the study, 6 were randomized to the CXL group and 7 to the non-CXL group. Five eyes in the CXL group and 3 eyes in the non-CXL group experienced treatment failure by 6 weeks (P = .56). In a secondary analysis, the CXL group experienced more perforations than the non-CXL group (4 vs 0, respectively; P = .02).
CXL used as adjuvant therapy for recalcitrant deep stromal fungal keratitis did not improve outcomes.
评估角膜交联术(CXL)作为辅助治疗手段用于难治性深层基质性真菌性角膜炎的适当抗真菌治疗中的疗效。
随机临床试验。
培养阳性的深层基质性真菌性角膜炎患者,若对适当的药物治疗2周无反应,则随机分为两组,一组接受辅助性CXL治疗,另一组不接受额外治疗。两组均继续进行抗真菌药物治疗。预先设定的主要结局是入组6周后的治疗失败,定义为穿孔和/或溃疡大小增加≥2毫米。
由于两组穿孔率存在显著差异,该试验在完全入组前停止。在纳入研究的13例病例中,6例随机分配至CXL组,7例至非CXL组。CXL组5只眼和非CXL组3只眼在6周时出现治疗失败(P = 0.56)。在一项次要分析中,CXL组比非CXL组出现更多穿孔(分别为4例和0例;P = 0.02)。
CXL作为难治性深层基质性真菌性角膜炎的辅助治疗方法并不能改善治疗效果。