Takagi Yasutaka, Osaki Hirotaka, Yamashita Tomohiro, Kai Yasuhiko
Scientific Information Group, Santen Pharmaceutical Co., Ltd, Ofukacho Kita-ku, Osaka, Japan.
Safety Vigilance Group, Santen Pharmaceutical Co., Ltd, Ofukacho Kita-ku, Osaka, Japan.
Ophthalmol Ther. 2016 Dec;5(2):191-206. doi: 10.1007/s40123-016-0057-3. Epub 2016 Aug 4.
The intraocular pressure (IOP)-lowering effect and safety of tafluprost 0.0015%/timolol maleate 0.5% combination ophthalmic solution (Taf-TFC) were investigated in a real-world clinical setting.
A prospective up to 2-year (more than 1 year) observational study has been initiated to collect data on the IOP, conjunctival hyperemia score, corneal staining score, and adverse events suffered by patients with glaucoma or ocular hypertension treated at 3 months, and up to 2 years (more than 1 year) after initiating treatment with Taf-TFC. The 3-month findings are reported here.
Among 439 patients enrolled at 100 institutions in Japan, most had normal tension glaucoma (45.3%) or primary open angle glaucoma (36.0%). Adverse drug reaction (ADR) occurred in 5.01%. The important ADRs were conjunctival hyperemia (five patients), blepharitis (four patients), and punctate keratitis (two patients). Serious adverse reactions occurred in two patients (three events). In 410 patients with data both before and after treatment, baseline mean IOP was 17.5 ± 5.0 mmHg, and it was significantly decreased after 1, 2, and 3 months (all P < 0.05, paired-t test). IOP was significantly reduced in patients switched to Taf-TFC from either prostaglandin or β-blocker monotherapy. IOP also decreased significantly in patients switched from a prostaglandin/timolol fixed combination, but not in patients switched from concomitant use of a prostaglandin analog and a β-blocker. The use of Taf-TFC did not worsen the adherence in most patients.
Taf-TFC significantly reduced the IOP in patients with glaucoma or ocular hypertension treated in daily clinical practice with controllable or recoverable ADRs in short period. Taf-TFC was effective regardless of treatment patterns, and particularly, Taf-TFC significantly reduced IOP in cases in which requiring the second line therapy as insufficient of monotherapy.
Santen Pharmaceutical Co., Ltd., Osaka, Japan.
在真实临床环境中研究了0.0015%他氟前列素/0.5%马来酸噻吗洛尔复方滴眼液（Taf-TFC）降低眼压（IOP）的效果及安全性。
开展了一项为期2年（超过1年）的前瞻性观察研究，以收集青光眼或高眼压症患者在使用Taf-TFC治疗3个月时以及治疗开始后长达2年（超过1年）的眼压、结膜充血评分、角膜染色评分和不良事件的数据。本文报告了3个月时的研究结果。
在日本100家机构招募的439例患者中，大多数患有正常眼压性青光眼（45.3%）或原发性开角型青光眼（36.0%）。药物不良反应（ADR）发生率为5.01%。重要的ADR包括结膜充血（5例患者）、睑缘炎（4例患者）和点状角膜炎（2例患者）。2例患者发生严重不良反应（3起事件）。在410例有治疗前后数据的患者中，基线平均眼压为17.5±5.0 mmHg，在1、2和3个月后显著降低（所有P<0.05，配对t检验）。从前列腺素或β受体阻滞剂单药治疗转换为Taf-TFC治疗的患者眼压显著降低。从前列腺素/噻吗洛尔固定复方转换治疗的患者眼压也显著降低，但从同时使用前列腺素类似物和β受体阻滞剂转换治疗的患者眼压未降低。在大多数患者中，使用Taf-TFC并未降低依从性。
Taf-TFC可显著降低日常临床中治疗的青光眼或高眼压症患者的眼压，且不良反应在短期内可控或可恢复。无论治疗方式如何，Taf-TFC均有效，特别是在单药治疗不足需要二线治疗的情况下，Taf-TFC可显著降低眼压。
日本大阪参天制药株式会社。
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