INTRAOCULAR-PRESSURE RESPONSE TO LOTEPREDNOL ETABONATE IN KNOWN STEROID RESPONDERS
INTRAOCULAR-PRESSURE RESPONSE TO LOTEPREDNOL ETABONATE IN KNOWN STEROID RESPONDERS
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DOI：
10.1089/jop.1993.9.157
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发表时间：
1993-06-01
期刊：
影响因子：
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通讯作者：
HOWES, JF
中科院分区：
文献类型：
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作者：
BARTLETT, JD;HORWITZ, B;HOWES, JF
眼用类固醇的持续发展已经产生了具有低升高眼内压（IOP）倾向的化合物。初步临床数据表明，氯替泼诺（LE）0.5%混悬液可能不会升高IOP，同时有望成为一种有效的局部眼用类固醇。本研究旨在评价局部LE和醋酸泼尼松龙（PA）在已知为类固醇反应者人群中升高IOP的比较潜力。本研究采用双盲、随机、单眼、交叉设计，比较LE 0.5%和PA 1.0%。受试者在清醒时滴入1滴指定药物，每日4次，并在第14、28和42天进行随访检查。经过至少14天的洗脱期后，受试者进入研究的第二阶段，该阶段与第一阶段相同，不同之处在于受试者接受了替代研究药物。LE组的平均IOP从基线时的17.4mm Hg增加到第42天的21.5mm Hg（p > 0.05），而PA组的平均IOP从基线时的18.1mm Hg增加到第42天的27.1mm Hg（p < 0.05）。两组均未发生严重、重度或临床显著事件，LE对IOP的影响与PA不同。与PA诱导的IOP反应相比，LE对IOP的影响较小。LE可能成为一种临床有用的眼用类固醇，具有良好的IOP安全性。
The continuing development of ophthalmic steroids has resulted in compounds that have a low tendency to raise intraocular pressure (IOP). Preliminary clinical data have suggested that loteprednol etabonate (LE) 0.5% suspension may not elevate IOP while having promise as a potent topical ophthalmic steroid. This study was designed to evaluate the comparative potential of topical LE and prednisolone acetate (PA) to raise IOP in a population of individuals known to be steroid responders. The study used a double-masked, randomized, single eye, crossover design comparing LE 0.5% and PA 1.0%. Subjects instilled 1 drop of the assigned medication 4 times daily while awake, and follow-up examinations occurred on days 14, 28, and 42. Following a washout period of at least 14 days, subjects entered the second phase of the study, which was identical to the first phase, except that subjects received the alternate study medication. The mean IOP in the LE group increased from 17.4mm Hg at baseline to 21.5mm Hg at day 42 (p > 0.05), while in the PA group the mean IOP increased from 18.1mm Hg at baseline to 27.1mm Hg at day 42 (p < 0.05). There were no serious, severe, or clinically significant events in either group, and LE's effect on IOP was differentiable from that of PA. LE has less effect on IOP when compared to the IOP response induced by PA. LE may become a clinically useful ocular steroid with a favorable IOP-safety profile.