Srinivasan M, Lalitha P, Mahalakshmi R, Prajna N V, Mascarenhas J, Chidambaram J D, Lee S, Hong K C, Zegans M, Glidden D V, McLeod S, Whitcher J P, Lietman T M, Acharya N R
Aravind Eye Care System, Madurai, India.
Br J Ophthalmol. 2009 Feb;93(2):198-202. doi: 10.1136/bjo.2008.147298. Epub 2008 Oct 1.
The aim of the study was to conduct a preliminary clinical trial to assess whether adjunctive topical corticosteroids improve outcomes in bacterial keratitis and, if no difference was found, to determine the feasibility and sample size necessary for conducting a larger trial to answer this question.
In this single centre, double-masked clinical trial, 42 patients with culture-confirmed bacterial keratitis at Aravind Eye Hospital in India were randomised to receive either topical prednisolone phosphate or placebo. All patients received topical moxifloxacin. The primary outcome was best spectacle-corrected visual acuity (BSCVA) at 3 months, adjusting for enrolment BSCVA and arm. Other pre-specified outcomes included re-epithelialisation time, infiltrate/scar size and adverse events.
Compared with placebo, patients in the steroid group re-epithelialised more slowly (hazard ratio 0.47, 95% CI 0.23 to 0.94). There was no significant difference in BSCVA or infiltrate/scar size at 3 weeks or 3 months. To have 80% power to detect a two-line difference in acuity, 360 cases would be required.
Although corticosteroid treatment resulted in a statistically significant delay in re-epithelialisation, this did not translate to a significant difference in visual acuity, infiltrate/scar size or adverse events. To assess the effect of steroids on acuity, a larger trial is warranted and feasible.
本研究旨在进行一项初步临床试验，以评估辅助局部使用皮质类固醇激素是否能改善细菌性角膜炎的治疗效果；若未发现差异，则确定开展一项更大规模试验来回答该问题所需的可行性和样本量。
在这项单中心、双盲临床试验中，印度阿拉文眼科医院的42例经培养确诊为细菌性角膜炎的患者被随机分为两组，分别接受局部使用磷酸泼尼松龙或安慰剂治疗。所有患者均接受局部使用莫西沙星治疗。主要结局指标为3个月时的最佳矫正视力（BSCVA），并对入组时的BSCVA和分组进行校正。其他预先设定的结局指标包括上皮化时间、浸润/瘢痕大小及不良事件。
与安慰剂组相比，类固醇组患者的上皮化速度更慢（风险比0.47，95%可信区间0.23至0.94）。在3周或3个月时，BSCVA或浸润/瘢痕大小无显著差异。要具备80%的把握度检测出视力上两行的差异，需要360例病例。
尽管皮质类固醇治疗在统计学上导致上皮化显著延迟，但这并未转化为视力、浸润/瘢痕大小或不良事件方面的显著差异。为评估类固醇对视力的影响，有必要且可行开展一项更大规模的试验。
