Costagliola Ciro, Parmeggiani Francesco, Antinozzi Paolo Pio, Caccavale Antonio, Cotticelli Luigi, Sebastiani Adolfo
Department of Ophthalmology, University of Ferrara, Ferrara, Italy.
Exp Eye Res. 2005 Nov;81(5):610-5. doi: 10.1016/j.exer.2005.03.020. Epub 2005 Jun 8.
The aim of this randomized, prospective, masked clinical study has been to verify the influence of a non-steroidal anti-inflammatory drug ophthalmic solution on intraocular pressure reduction induced by 0.5% timolol and 0.005% latanoprost eyedrops in patients affected by primary open-angle glaucoma. Thirty-two glaucomatous patients, compensated with 0.5% timolol, were randomized into two study groups (A and B). Timolol was continued for the first 2 weeks in all subjects. On the 15th day, in both groups timolol was replaced by latanoprost, and this regimen lasted up to the end of the follow-up (8 weeks). At the beginning of the 2nd week of the study, group A additionally started a 5-week therapy with topical 0.1% diclofenac; during the same period, group B received placebo eyedrops with identical modalities. Intraocular pressure was recorded at 7-day intervals during the first 7 weeks and at the 10th week. Non-steroidal anti-inflammatory drug and placebo did not modify the effect of timolol on intraocular pressure. In both groups, latanoprost induced a significant decrease in intraocular pressure. Diclofenac-treated patients exhibited a marked fall in intraocular pressure (p<0.01), whereas in placebo-treated patients, this diminution was less noticeable (p<0.05). After diclofenac withdrawal, in group A intraocular pressure significantly increased (p<0.01), remaining approximately at the same level up to the end of the study. In group B, at the same checks no significant variations in intraocular pressure occurred. In primary open-angle glaucoma patients, diclofenac significantly enhances the hypotensive effect of latanoprost, without influence on timolol efficacy. Because non-steroidal anti-inflammatory drugs are widely employed in medical practice, supplementary ophthalmologic checks should be scheduled during the co-administration of these compounds and prostaglandin analogues.
这项随机、前瞻性、双盲临床研究的目的是验证一种非甾体抗炎药眼药水对原发性开角型青光眼患者使用0.5%噻吗洛尔和0.005%拉坦前列素眼药水降低眼压的影响。32名使用0.5%噻吗洛尔病情得到控制的青光眼患者被随机分为两个研究组（A组和B组）。所有受试者在最初2周继续使用噻吗洛尔。在第15天，两组的噻吗洛尔均被拉坦前列素替代，该用药方案持续至随访结束（8周）。在研究第2周开始时，A组额外开始为期5周的局部使用0.1%双氯芬酸治疗；在此期间，B组以相同方式接受安慰剂眼药水。在最初7周内每7天记录一次眼压，在第10周也记录眼压。非甾体抗炎药和安慰剂均未改变噻吗洛尔对眼压的作用。两组中，拉坦前列素均使眼压显著降低。双氯芬酸治疗的患者眼压明显下降（p<0.01），而安慰剂治疗的患者眼压下降不太明显（p<0.05）。停用双氯芬酸后，A组眼压显著升高（p<0.01），直至研究结束时大致保持在同一水平。在B组，相同检查时眼压无显著变化。在原发性开角型青光眼患者中，双氯芬酸显著增强拉坦前列素的降压作用，而对噻吗洛尔的疗效无影响。由于非甾体抗炎药在医学实践中广泛使用，在这些化合物与前列腺素类似物联合使用期间应安排补充眼科检查。
