Department of Ophthalmology, The Jikei University School of Medicine, 3-19-18 Nishi-Shinbashi, Minato-ku, Tokyo 105-8461, Japan.
Jpn J Ophthalmol. 2011 Nov;55(6):605-13. doi: 10.1007/s10384-011-0082-7. Epub 2011 Aug 27.
To evaluate the intraocular pressure (IOP)-reducing effects and safety of 0.0015% tafluprost ophthalmic solution (tafluprost) in normal-tension glaucoma (NTG) patients with an IOP of 16 mmHg or less.
NTG patients with a baseline IOP of 16 mmHg or less were enrolled for a one-eye study in which tafluprost was applied once daily for 12 weeks. The presence of adverse drug reactions and the cumulative incidence of adverse events were also investigated.
Among the 44 enrolled patients, 41/44 (93.2%) eyes completed the study. The baseline IOP was 13.2 ± 1.3 mmHg in the study eyes and 13.0 ± 1.3 mmHg in the fellow eyes, which was not statistically significant (P = 0.9173, Student's t test). The values obtained for IOP in the study eyes versus fellow eyes were 10.2 ± 1.6 versus 12.1 ± 1.5 mmHg at week 12. The IOP difference between the study eyes and the fellow eyes was statistically significant (P < 0.0001, Student's t test). The cumulative incidence of adverse events was 58.5% by week 12. Ocular itching was the most frequently observed adverse event (29.3%). All adverse events were clinically tolerable.
Tafluprost induced significant IOP reductions in NTG patients with a baseline IOP of 16 mmHg or less without raising any safety concerns.
评估 0.0015%他氟前列素滴眼液（他氟前列素）在眼压（IOP）为 16mmHg 或以下的正常眼压性青光眼（NTG）患者中的降眼压效果和安全性。
纳入基线 IOP 为 16mmHg 或以下的 NTG 患者进行单眼研究，每天应用他氟前列素治疗 12 周。还研究了药物不良反应的发生情况和不良事件的累积发生率。
在纳入的 44 例患者中，41/44（93.2%）只眼完成了研究。研究眼的基线 IOP 为 13.2 ± 1.3mmHg，对侧眼为 13.0 ± 1.3mmHg，差异无统计学意义（P = 0.9173，Student's t 检验）。研究眼与对侧眼的 IOP 值在第 12 周分别为 10.2 ± 1.6mmHg 和 12.1 ± 1.5mmHg。研究眼与对侧眼的 IOP 差值具有统计学意义（P < 0.0001，Student's t 检验）。第 12 周时不良事件的累积发生率为 58.5%。眼部瘙痒是最常见的不良反应（29.3%）。所有不良事件均具有临床耐受性。
他氟前列素可使基线 IOP 为 16mmHg 或以下的 NTG 患者的 IOP 显著降低，且无安全性问题。
