Rhee Steven S, Mah Francis S
University of Pittsburgh School of Medicine, Department of Ophthalmology, UPMC Eye Center, Pittsburgh, PA 15213-2588, USA.
Adv Ther. 2007 Jan-Feb;24(1):60-7. doi: 10.1007/BF02849993.
In this clinical trial, investigators compared the effectiveness of 2 commercially formulated antibiotic/steroid combinations - tobramycin 0.3%/dexamethasone 0.1% (Tobradex; Alcon, Fort Worth, Tex) and tobramycin 0.3%/loteprednol 0.5% (Zylet; Bausch & Lomb Inc., Rochester, NY) - for rapidly controlling inflammation in patients with blepharo-keratoconjunctivitis. Investigators in this randomized, parallel-group, double-masked study examined 40 eyes of 40 patients with blepharo-keratoconjunctivitis. Patients received tobramycin 0.3%/dexamethasone 0.1% or tobramycin 0.3%/loteprednol 0.5% twice daily in the test eye, according to the randomization schedule. At baseline, the ocular surface was graded on a scale of 3 (extensive) to 0 (minimum) for 4 components: blepharitis, conjunctivitis, ocular discharge, and corneal punctate epithelial keratopathy (PEK). Only those patients with moderate to extensive inflammation (cumulative score >6) were included in the study. At follow-up 3 to 5 d later, the ocular surface was regraded so that treatment response could be evaluated. No statistically significant difference was noted between groups in pretreatment scores for blepharitis (P=.31), discharge (P=.62), conjunctivitis (P=1.0), and PEK (P=.57), or for total ocular inflammation (P=.87). Mean posttreatment scores were as follows: total ocular surface scores, 1.8 and 3.4 (P=.002); blepharitis scores, 0.9 and 1.35 (P=.017); discharge scores, 0.2 and 0.6 (P=.025); and conjunctivitis scores, 0.15 and 0.6 (P=.013) for tobramycin/dexamethasone and tobramycin/loteprednol, respectively. Corneal PEK scores were not significantly different between treatments. Tobramycin 0.3%/dexamethasone 0.1% significantly decreased clinical signs of ocular inflammation (ie, blepharitis, discharge, conjunctivitis) and total ocular inflammation scores when compared with tobramycin 0.3%/loteprednol 0.5% in patients with moderate to severe blepharo-keratoconjunctivitis. The 2 regimens also provided comparably rapid decreases in corneal PEK.
在这项临床试验中，研究人员比较了两种市售抗生素/类固醇组合——0.3%妥布霉素/0.1%地塞米松（托百士；爱尔康公司，得克萨斯州沃思堡）和0.3%妥布霉素/0.5%洛替泼诺（泽利特；博士伦公司，纽约州罗切斯特）——对睑缘角结膜炎患者炎症快速控制的有效性。这项随机、平行组、双盲研究的研究人员检查了40例睑缘角结膜炎患者的40只眼睛。根据随机分组方案，患者在受试眼中每日两次使用0.3%妥布霉素/0.1%地塞米松或0.3%妥布霉素/0.5%洛替泼诺。在基线时，对睑缘炎、结膜炎、眼部分泌物和角膜点状上皮病变（PEK）这4个组分的眼表按3级（广泛）至0级（最小）进行分级。只有那些中度至重度炎症（累积评分>6）的患者被纳入研究。在3至5天后的随访中，对眼表重新分级以便评估治疗反应。两组在睑缘炎（P = 0.31）、分泌物（P = 0.62）、结膜炎（P = 1.0）和PEK（P = 0.57）的治疗前评分或总眼部炎症评分（P = 0.87）方面均未发现统计学上的显著差异。治疗后的平均评分如下：总眼表评分，分别为1.8和3.4（P = 0.002）；睑缘炎评分，分别为0.9和1.35（P = 0.017）；分泌物评分，分别为0.2和0.6（P = 0.025）；结膜炎评分，分别为0.15和0.6（P = 0.013），分别对应妥布霉素/地塞米松组和妥布霉素/洛替泼诺组。两种治疗方法的角膜PEK评分无显著差异。在中度至重度睑缘角结膜炎患者中，与0.3%妥布霉素/0.5%洛替泼诺相比，0.3%妥布霉素/0.1%地塞米松显著降低了眼部炎症的临床体征（即睑缘炎、分泌物、结膜炎）和总眼部炎症评分。两种治疗方案在角膜PEK方面也能使病情得到同样快速的缓解。
