背景:前列腺素类似物(PGAs)是原发性开角型青光眼(POAG)和高眼压症(OH)的一线治疗方法。这项研究旨在证实Tapros®(0.0015%他氟前列素滴眼液)在中国POAG和OH患者中的有效性和安全性。
方法:第四阶段,多中心,非比较性,前瞻性研究纳入了2017年12月27日至2020年04月15日在中国患有POAG和OH的患者。未治疗或未治疗的患者在一个月内(A组)或先前单一治疗其他PGA(B组)或非PGA降低IOP的药物(C组)后未达到眼内压(IOP)目标,接受0.0015%他氟前列素治疗三个月。降低IOP,响应率,并观察到安全性。
结果:A组中有165、89和31例患者,B,C,基线IOP为22.4±4.7、21.0±3.5和22.5±3.2mmHg,分别。A组3个月时IOP降低的最小二乘均值和百分比,B,C为4.7(19.8%),1.6(6.1%),和4.6mmHg(20.3%),分别。与基线相比,在每次访视时观察到IOP显著降低(所有P<0.05)。在最后一次访问中,A组中57.0%的参与者实现IOP降低≥20%,而B组和C组分别为40.4%和77.4%,IOP降低≥10%。46名参与者(15.7%)发生了58起与治疗相关的不良事件,其中最常见的是结膜充血(34/293,11.6%)。
结论:他氟前列素在中国POAG和OH患者中表现出持续和显著的效果,并且有可耐受的不良事件,这些患者在1个月内未接受治疗或未接受治疗,结果不满意。
BACKGROUND: Prostaglandin analogs (PGAs) are the first-line treatment for primary open-angle glaucoma (POAG) and ocular hypertension (OH). This study aimed to confirm the effectiveness and safety of Tapros® (0.0015%
tafluprost eye drops) in Chinese patients with POAG and OH.
METHODS: This phase IV, multicenter, non-comparative, prospective study enrolled patients with POAG and OH in China between 12/27/2017 and 04/15/2020. Patients who were treatment-naïve or untreated within one month (group A) or with unreached intraocular pressure (IOP) target after previous monotherapy of other PGAs (group B) or non-PGA IOP-lowering drugs (group C) were treated with 0.0015%
tafluprost for three months. The IOP reduction, response rate, and safety were observed.
RESULTS: There were 165, 89, and 31 patients in groups A, B, and C, with baseline IOPs of 22.4 ± 4.7, 21.0 ± 3.5, and 22.5 ± 3.2 mmHg, respectively. The least-square means and percentages of IOP reduction at 3 months for groups A, B, and C were 4.7 (19.8%), 1.6 (6.1%), and 4.6 mmHg (20.3%), respectively. A significant reduction in IOP was observed at each visit compared with baseline (all P < 0.05). At the final visit, 57.0% of the participants in group A achieved an IOP reduction of ≥ 20%, while 40.4% and 77.4% in groups B and C achieved an IOP reduction of ≥ 10%. Fifty-eight treatment-related adverse events occurred in 46 participants (15.7%), of which the most common one was conjunctival hyperemia (34/293, 11.6%).
CONCLUSIONS: Tafluprost showed a sustained and significant effect with tolerable adverse events in Chinese patients with POAG and OH who were treatment-naïve or untreated within one month or received prior treatments with unsatisfying outcomes.