Nakano Tadashi, Mizoue Shiro, Fuse Nobuo, Iwase Aiko, Matsumoto Shun, Yoshikawa Keiji
Department of Ophthalmology, The Jikei University School of Medicine, Nishi-Shimbashi, Minato-ku, Tokyo.
Department of Ophthalmology, Ehime University Graduate School of Medicine, Shitsukawa, Toon-city, Ehime.
Clin Ophthalmol. 2016 Dec 20;11:55-61. doi: 10.2147/OPTH.S120639. eCollection 2017.
We have shown a decrease in mean intraocular pressure (IOP) by switching to travoprost/timolol fixed combination (TTFC) in subjects receiving prostaglandin analogue (PGA) monotherapy and requiring additional medication in a previous report. For analyzing factors affecting IOP reduction, baseline IOP and preceding PGA were selected as statistically and clinically significant factors. In this report, we examine IOP-lowering effect and adverse drug reactions by preceding PGA.
Patients with primary open angle glaucoma or ocular hypertension who received monotherapy with one of four PGAs (travoprost, latanoprost, tafluprost, or bimatoprost) for at least 3 months at 26 institutions and were determined to require additional medication by their primary physician were included. IOP reduction and adverse events were examined at 4, 8, and 12 weeks for each of four PGAs after switching to TTFC.
In total, 157 patients who could be followed up for at least 4 weeks after switching to TTFC were included in the efficacy analysis. Multiple regression analysis was performed, and baseline IOP and PGA were found to be significant factors to IOP reduction. IOP reduction at week 12, adjusted with the regression model, was -3.5, -1.8, and -1.4 mmHg in the tafluprost, latanoprost, and travoprost groups, whereas it was -0.5 mmHg in the bimatoprost group. Along with differences in baseline IOP between groups, an IOP-lowering effect of >1 mmHg was noted in the tafluprost, latanoprost, and travoprost groups after the switch. IOP was maintained at 13.8-14.8 mmHg throughout the follow-up period. No serious adverse events or noteworthy issues were observed in any group after the switch.
Clinically significant IOP-reducing effects of TTFC were observed in the latanoprost, travoprost, and tafluprost groups when switching from each PGA monotherapy, while there were some differences in effects between groups, with minimal safety concerns.
在之前的一份报告中，我们发现，在接受前列腺素类似物（PGA）单药治疗且需要额外用药的受试者中，改用曲伏前列素/噻吗洛尔固定复方制剂（TTFC）后平均眼压（IOP）有所降低。为分析影响眼压降低的因素，将基线眼压和之前使用的PGA作为具有统计学和临床意义的因素。在本报告中，我们按之前使用的PGA来研究眼压降低效果和药物不良反应。
纳入在26家机构接受四种PGA（曲伏前列素、拉坦前列素、他氟前列素或比马前列素）之一单药治疗至少3个月且经主治医生判定需要额外用药的原发性开角型青光眼或高眼压症患者。改用TTFC后，在4周、8周和12周时分别对四种PGA的眼压降低情况和不良事件进行检查。
疗效分析纳入了157例改用TTFC后至少能随访4周的患者。进行了多元回归分析，发现基线眼压和PGA是眼压降低的显著因素。经回归模型校正后，他氟前列素、拉坦前列素和曲伏前列素组在第12周时眼压降低值分别为-3.5、-1.8和-1.4 mmHg，而比马前列素组为-0.5 mmHg。除各组基线眼压存在差异外，改用药物后他氟前列素、拉坦前列素和曲伏前列素组的眼压降低效果>1 mmHg。在整个随访期间，眼压维持在13.8 - 14.8 mmHg。改用药物后，任何组均未观察到严重不良事件或值得注意的问题。
从每种PGA单药治疗改用TTFC时，拉坦前列素、曲伏前列素和他氟前列素组均观察到具有临床意义的眼压降低效果，尽管各组效果存在一些差异，但安全性问题极小。
