从非固定复方制剂换用0.005%拉坦前列素+0.5%马来酸噻吗洛尔固定复方制剂12个月后眼压降低效果及安全性评估
Assessment of ocular hypotensive effect and safety 12 months after changing from an unfixed combination to a latanoprost 0.005% + timolol maleate 0.5% fixed combination.
作者信息
Inoue Kenji, Okayama Ryoko, Higa Risako, Wakakura Masato, Tomita Goji
机构信息
Inouye Eye Hospital, 4-3 Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan.
出版信息
Clin Ophthalmol. 2012;6:607-12. doi: 10.2147/OPTH.S30611. Epub 2012 Apr 18.
BACKGROUND
Latanoprost 0.005% + timolol maleate 0.5% combined eyedrops were recently made available in Japan. We prospectively investigated the intraocular pressure (IOP)-lowering effect, visual preservation effect, and adverse reactions of a one-year administration of this fixed combination.
METHODS
The subjects included 162 eyes from 162 patients diagnosed with either primary open-angle glaucoma or ocular hypertension and using an unfixed combination of latanoprost 0.005% and timolol maleate 0.5%. The unfixed combination was discontinued and replaced with the latanoprost 0.005% + timolol maleate 0.5% fixed combination with no washout period. IOP was measured before (baseline) and 3, 6, 9, and 12 months after the change. The mean deviation value of Humphrey field analysis was compared. Adverse reactions were examined at every follow-up.
RESULTS
No significant differences were found between mean IOP values obtained at baseline (mean ± standard deviation, 15.2 ± 3.3 mmHg) 3 months (15.1 ± 3.2 mmHg), 6 months (15.3 ± 3.1 mmHg), 9 months (15.3 ± 3.1 mmHg), and 12 months (15.1 ± 3.2 mmHg) after the change from the unfixed to the fixed combination of eyedrops (P = 0.212). In addition, no significant differences were observed between mean deviation values obtained at baseline (-9.11 ± 6.94 dB) and 12 months (-10.08 ± 7.24 dB) after the change (P = 0.114). Thirty-one patients discontinued the fixed combination within 12 months of replacement, due to an insufficient IOP decrease (20 patients, 12.3%) and adverse reactions (11 patients, 6.8%).
CONCLUSION
Following replacement of two eyedrop medications (latanoprost 0.005% and timolol maleate 0.5%) by one fixed combination (latanoprost 0.005% + timolol maleate 0.5%), IOP and visual field were preserved. However, 20% of the patients discontinued the new treatment because of an insufficient IOP decrease and complaints of adverse reactions.
背景
0.005%拉坦前列素+0.5%马来酸噻吗洛尔复方滴眼液最近在日本上市。我们前瞻性地研究了这种固定复方制剂一年给药的降眼压效果、视力保护效果及不良反应。
方法
研究对象包括162例诊断为原发性开角型青光眼或高眼压症且正在使用0.005%拉坦前列素和0.5%马来酸噻吗洛尔非固定复方制剂的患者的162只眼。停用非固定复方制剂，直接换用0.005%拉坦前列素+0.5%马来酸噻吗洛尔固定复方制剂，无洗脱期。在换药前（基线）以及换药后3、6、9和12个月测量眼压。比较Humphrey视野分析的平均偏差值。每次随访时检查不良反应。
结果
从非固定复方制剂换为固定复方制剂后，基线时（均值±标准差，15.2±3.3 mmHg）、3个月（15.1±3.2 mmHg）、6个月（15.3±3.1 mmHg）、9个月（15.3±3.1 mmHg）和12个月（15.1±3.2 mmHg）时获得的平均眼压值之间无显著差异（P = 0.212）。此外，换药后基线时（-9.11±6.94 dB）和12个月时（-10.08±7.2 dB）获得的平均偏差值之间也未观察到显著差异（P = 0.114）。31例患者在换药后12个月内停用了固定复方制剂，原因是眼压降低不足（20例患者，12.3%）和出现不良反应（11例患者，6.8%）。
结论
将两种滴眼液药物（0.005%拉坦前列素和0.5%马来酸噻吗洛尔）换成一种固定复方制剂（0.005%拉坦前列素+0.5%马来酸噻吗洛尔）后，眼压和视野得以维持。然而，20%的患者因眼压降低不足和不良反应主诉而停用了新治疗方案。
Zotero 插件