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[与安慰剂相比,0.0015%他氟前列素对正常眼压性青光眼患者的降眼压效果:随机、双盲、多中心、III期研究]

[Intraocular pressure lowering effect of 0.0015% tafluprost as compared to placebo in patients with normal tension glaucoma: randomized, double-blind, multicenter, phase III study].

作者信息

Kuwayama Yasuaki, Komemushi Sadao

机构信息

Department of Ophthalmology, Osaka Koseinenkin Hospital, Japan.

出版信息

Nippon Ganka Gakkai Zasshi. 2010 May;114(5):436-43.

PMID:20545217
Abstract

PURPOSE

To compare the efficacy and safety of 0.0015% tafluprost ophthalmic solution (Tafluprost) with Placebo ophthalmic solution (Placebo) in normal tension glaucoma (NTG).

SETTING

Total of 94 patients enrolled in a randomized, double-blind, parallel-group and multicenter study.

METHOD

Patients with NTG were randomly assigned to either Tafluprost or Placebo. Both ophthalmic solutions were instilled once a day in the morning for 4 weeks.

RESULTS

Mean intraocular pressure (IOP) changes from baseline were -4.0 +/- 1.7 mmHg in Tafluprost administered patients and -1.4 +/- 1.8 mmHg in Placebo administered patients at 4 weeks, with a statistically significant difference (p<0.001). IOP change at 4 weeks, % IOP reduction at 2 and 4 weeks were also significantly greater in Tafluprost than in Placebo. A total of 51.0% in Tafluprost treated group and 8.9% in Placebo treated group reported adverse drug reactions.

CONCLUSION

These results indicate that Tafluprost is clinically useful in the treatment of NTG.

摘要

目的

比较0.0015%他氟前列素滴眼液(他氟前列素)与安慰剂滴眼液在正常眼压性青光眼(NTG)治疗中的疗效和安全性。

设置

共有94例患者参与了一项随机、双盲、平行组多中心研究。

方法

NTG患者被随机分配至他氟前列素组或安慰剂组。两种滴眼液均于每天早晨滴注一次,持续4周。

结果

4周时,使用他氟前列素的患者平均眼压(IOP)较基线变化为-4.0±1.7 mmHg,使用安慰剂的患者为-1.4±1.8 mmHg,差异有统计学意义(p<0.001)。他氟前列素组4周时的IOP变化、2周和4周时的IOP降低百分比也显著高于安慰剂组。他氟前列素治疗组共有51.0%的患者报告有药物不良反应,安慰剂治疗组为8.9%。

结论

这些结果表明他氟前列素在NTG治疗中具有临床应用价值。

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