Katz Gregory, Springs Clark L, Craven E Randy, Montecchi-Palmer Michela
Huron Ophthalmology, Ypsilanti, MI, USA.
Clin Ophthalmol. 2010 Nov 3;4:1253-61. doi: 10.2147/OPTH.S14113.
The preservative benzalkonium chloride (BAK) may adversely affect ocular surface health. This study evaluated symptoms of ocular surface disease (OSD) in patients previously treated with a BAK-preserved therapy to lower their intraocular pressure, who either continued that therapy or switched to a BAK-free therapy.
Eligible adult patients with ocular hypertension or open-angle glaucoma that had been controlled with BAK-preserved latanoprost 0.005% monotherapy (Xalatan ®) for at least one month and had a score of ≥ 13 (0 = none, 100 = most severe) on the Ocular Surface Disease Index (OSDI) questionnaire were entered into this prospective, double-masked, randomized, active-controlled, multicenter trial. By random assignment, patients either continued with BAK-preserved latanoprost 0.005% or transitioned to BAK-free travoprost 0.004% (Travatan Z ® ophthalmic solution). OSDI scores were assessed again after six and 12 weeks.
For the 678 evaluable patients, mean change in OSDI score from baseline to week 12 favored the travoprost 0.004% BAK-free group, but was not statistically different between groups (P = 0.10). When patients with mild OSD at baseline were assessed after 12 weeks, the mean OSDI score was significantly lower (P = 0.04) in the BAK-free travoprost 0.004% group (score = 11.6 ± 10.8 units) than in the BAK-preserved latanoprost 0.005% group (score = 14.4 ± 11.9 units), and a significantly larger percentage (P < 0.01) improved to normal OSDI scores in the BAK-free travoprost 0.004% group (62.9% of group) than in the BAK-preserved latanoprost 0.005% group (47.0% of group). Patients pretreated with BAK-preserved latanoprost 0.005% for >24 months were significantly more likely (P = 0.03) to improve to a normal OSDI score after 12 weeks if they were switched to BAK-free travoprost 0.004% (47.9% of group) than if they remained on BAK-preserved latanoprost 0.005% (33.9% of group).
Switching from BAK-preserved latanoprost 0.005% to BAK-free travoprost 0.004% yielded significant improvements in symptoms of OSD in patients with glaucoma or ocular hypertension.
防腐剂苯扎氯铵（BAK）可能会对眼表健康产生不利影响。本研究评估了先前接受BAK保存疗法以降低眼压的患者的眼表疾病（OSD）症状，这些患者要么继续接受该疗法，要么改用无BAK疗法。
符合条件的成年高眼压症或开角型青光眼患者，使用BAK保存的0.005%拉坦前列素单药治疗（适利达®）至少一个月，且在眼表疾病指数（OSDI）问卷上得分≥13（0 = 无，100 = 最严重），被纳入这项前瞻性、双盲、随机、活性对照、多中心试验。通过随机分配，患者要么继续使用BAK保存的0.005%拉坦前列素，要么改用无BAK的0.004%曲伏前列素（苏为坦®眼药水）。在6周和12周后再次评估OSDI评分。
对于678例可评估患者，从基线到第12周OSDI评分的平均变化有利于0.004%无BAK曲伏前列素组，但两组之间无统计学差异（P = 0.10）。在基线时患有轻度OSD的患者在12周后进行评估时，0.004%无BAK曲伏前列素组的平均OSDI评分（评分 = 11.6±10.8单位）显著低于0.005%BAK保存拉坦前列素组（评分 = 14.4±11.9单位）（P = 0.04），且0.004%无BAK曲伏前列素组改善至正常OSDI评分的百分比显著更高（P < 0.01）（组内62.9%），高于0.005%BAK保存拉坦前列素组（组内47.0%）。先前使用0.005%BAK保存拉坦前列素治疗>24个月的患者，如果改用0.004%无BAK曲伏前列素，在12周后改善至正常OSDI评分的可能性显著更高（P = 0.03）（组内47.9%），高于继续使用0.005%BAK保存拉坦前列素的患者（组内33.9%）。
从0.005%BAK保存的拉坦前列素改用0.004%无BAK的曲伏前列素可使青光眼或高眼压症患者的OSD症状得到显著改善。
