Egorov Evgeny, Ropo Auli
Russian State Medical University, Moscow - Russia.
Eur J Ophthalmol. 2009 Mar-Apr;19(2):214-22. doi: 10.1177/112067210901900207.
This study investigated the efficacy and safety of tafluprost as an adjunctive therapy to timolol in patients with open-angle glaucoma or ocular hypertension, uncontrolled by timolol monotherapy.
This was a randomized, double-masked, parallel-group, multinational and multicenter 12-week phase III study. Tafluprost 0.0015% (once daily: 20:10) or vehicle were administered as adjunctive therapy to timolol 0.5% (twice daily: 08:00 and 20:00) for 6 weeks, after which all patients received tafluprost for 6 weeks. Intraocular pressure (IOP) measurements were conducted at 08:00, 10:00, and 16:00 at baseline, and weeks 2, 4, 6, and 12.
A total of 185 patients were randomized to tafluprost (n = 96) or vehicle (n = 89). Reductions in IOP were seen in both groups, which were consistently more pronounced with tafluprost. At week 6, the change from baseline in diurnal IOP ranged from -5.49 to -5.82 mmHg, and the overall treatment difference (tafluprost vehicle) was -1.49 mmHg (upper 95% confidence interval, -0.66; p<0.001, intention-to-treat population, repeated measurements of the analysis of covariance model). At week 12, the change from baseline ranged from -6.22 to -6.79 mmHg in the tafluprost group. Patients switched from vehicle to tafluprost achieved a similar decrease in IOP to those who received tafluprost throughout the study (group difference at 12 weeks, -0.09 mmHg, p=0.812). There were more ocular adverse events with tafluprost compared with vehicle (42% vs. 29%, respectively), but most were mild in severity.
As adjunctive therapy to timolol, tafluprost achieved a consistently greater reduction in IOP compared with vehicle, and was well tolerated.
本研究调查了他氟前列素作为噻吗洛尔辅助治疗药物，用于治疗单药使用噻吗洛尔无法控制的开角型青光眼或高眼压症患者的疗效和安全性。
这是一项随机、双盲、平行组、多国多中心的12周III期研究。他氟前列素0.0015%（每日一次：20:10）或赋形剂作为噻吗洛尔0.5%（每日两次：08:00和20:00）的辅助治疗药物使用6周，之后所有患者均接受他氟前列素治疗6周。在基线、第2、4、6和12周的08:00、10:00和16:00测量眼压（IOP）。
共有185例患者被随机分为他氟前列素组（n = 96）或赋形剂组（n = 89）。两组患者的眼压均有所降低，他氟前列素组的降低幅度始终更为显著。在第6周时，日间眼压相对于基线的变化范围为-5.49至-5.82 mmHg，总体治疗差异（他氟前列素-赋形剂）为-1.49 mmHg（95%置信区间上限，-0.66；p<0.001，意向性治疗人群，协方差模型重复测量分析）。在第12周时，他氟前列素组相对于基线的变化范围为-6.22至-6.79 mmHg。从赋形剂组换用他氟前列素组的患者眼压降低幅度与整个研究期间均接受他氟前列素治疗的患者相似（第12周时组间差异为-0.09 mmHg，p = 0.812）。与赋形剂相比，他氟前列素导致的眼部不良事件更多（分别为42%和29%），但大多数严重程度较轻。
作为噻吗洛尔的辅助治疗药物，他氟前列素与赋形剂相比，能持续更显著地降低眼压，且耐受性良好。
