Okumichi Hideaki, Kiuchi Yoshiaki, Baba Tetsuya, Kanamoto Takashi, Naito Tomoko, Nakakura Shunsuke, Tabuchi Hitoshi, Nii Hiroki, Sueoka Chie, Sugimoto Yosuke
Department of Ophthalmology and Visual Science, Graduate School of Biomedical & Health Sciences, Hiroshima University, Hiroshima, Japan.
Shirai Eye Hospital, Mitoyo, Japan.
Clin Ophthalmol. 2017 Jun 21;11:1175-1181. doi: 10.2147/OPTH.S136418. eCollection 2017.
To evaluate the ocular-surface safety of a 0.001% benzalkonium chloride-containing tafluprost/timolol fixed combination (TTFC) in patients with primary open-angle glaucoma (POAG) or ocular hypertension who have inadequate intraocular pressure (IOP) control with latanoprost monotherapy.
This study is a multicenter, prospective, single-arm, open-label clinical study. Patients with POAG or ocular hypertension who have inadequate IOP control with latanoprost monotherapy were considered eligible. After providing informed consent, patients continued latanoprost monotherapy for 12 weeks, followed by a switch to TTFC. We evaluated the extent of ocular-surface damage using superficial punctate keratopathy (SPK) score, tear breakup time (TBUT), hyperemia score, IOP, systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate at 0, 4, and 12 weeks after switching.
A total of 68 patients were enrolled, of whom, 64 patients were included in the final analysis. No significant changes in SPK score, TBUT, or hyperemia score were observed at 4 and 12 weeks compared with week 0. IOP decreased significantly at 4 (13.9±2.5 mmHg) and 12 (14.1±2.5 mmHg) weeks, relative to week 0 (15.3±2.7 mmHg). No significant changes in either SBP or DBP were observed during the study, although patients' mean heart rate decreased significantly after switching to TTFC. Adverse drug reactions to TTFC occurred in seven patients including two incidences of asthma and one of arrhythmia, and no events were serious.
The ocular-surface safety of TTFC is not significantly different to that of latanoprost. Furthermore, switching from latanoprost to TTFC in patients with insufficient IOP control has additive IOP-lowering effects. TTFC is an effective approach for patients receiving latanoprost monotherapy who require more intensive IOP reduction.
评估含0.001%苯扎氯铵的他氟前列素/噻吗洛尔固定复方制剂（TTFC）对原发性开角型青光眼（POAG）或眼压高且使用拉坦前列素单药治疗眼压控制不佳患者的眼表安全性。
本研究为多中心、前瞻性、单臂、开放标签的临床研究。使用拉坦前列素单药治疗眼压控制不佳的POAG或眼压高患者被视为符合条件。在获得知情同意后，患者继续使用拉坦前列素单药治疗12周，随后换用TTFC。我们在换药后0、4和12周使用浅层点状角膜炎（SPK）评分、泪膜破裂时间（TBUT）、充血评分、眼压、收缩压（SBP）、舒张压（DBP）和心率评估眼表损伤程度。
共纳入68例患者，其中64例患者纳入最终分析。与第0周相比，第4周和第12周时SPK评分、TBUT或充血评分均未观察到显著变化。相对于第0周（15.3±2.7 mmHg），眼压在第4周（13.9±2.5 mmHg）和第12周（14.1±2.5 mmHg）时显著降低。研究期间SBP和DBP均未观察到显著变化，尽管患者在换用TTFC后平均心率显著降低。7例患者出现了对TTFC的药物不良反应，包括2例哮喘发作和1例心律失常，且均无严重事件。
TTFC的眼表安全性与拉坦前列素无显著差异。此外，对于眼压控制不佳的患者，从拉坦前列素换用TTFC具有额外的降眼压作用。对于接受拉坦前列素单药治疗且需要更强力度降低眼压的患者，TTFC是一种有效的治疗方法。
