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一种新型水凝胶制剂在人体志愿者中的疗效。

Efficacy of a novel hydrogel formulation in human volunteers.

作者信息

Mayer H, von der Ohe N

机构信息

Kinik und Poliklinik fur Augenheilkunde, Medizinische Hochschule Hannover, Deutschland.

出版信息

Ophthalmologica. 1996;210(2):101-3. doi: 10.1159/000310682.

DOI:10.1159/000310682
PMID:9148253
Abstract

In a two-period crossover study, 20 subjects without an ocular disease received single doses of either a novel timolol hydrogel (T-Gel 0.1%) or aqueous timolol 0.5% in one eye and placebo in the fellow eye. Diurnal variation curves of intraocular pressure of both eyes were obtained for a 24-hour period. Peak effects up to -30% of the baseline were observed. A statistically significant residual effect was still detectable 24 h after application. The timolol gel had the same efficacy in lowering intraocular pressure as the commercially available aqueous timolol solution with a five times higher strength. Equivalence of treatment effects was statistically proved.

摘要

在一项两阶段交叉研究中,20名无眼部疾病的受试者单眼接受新型噻吗洛尔水凝胶(0.1%噻吗洛尔凝胶)或0.5%噻吗洛尔水溶液,另一只眼接受安慰剂。在24小时内获取双眼眼压的昼夜变化曲线。观察到峰值效应高达基线的-30%。用药后24小时仍可检测到具有统计学意义的残留效应。噻吗洛尔凝胶降低眼压的效果与市售强度高五倍的噻吗洛尔水溶液相同。治疗效果的等效性得到了统计学证明。

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引用本文的文献

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Preservative-Free Gel-Formulated Glaucoma Therapies: Learning from the Past, Looking to the Future.无防腐剂凝胶剂型青光眼治疗药物:回顾过去,展望未来。
Adv Ther. 2025 Oct 13. doi: 10.1007/s12325-025-03342-0.
2
Timolol 0.1% in Glaucomatous Patients: Efficacy, Tolerance, and Quality of Life.青光眼患者使用0.1%噻吗洛尔的疗效、耐受性及生活质量
J Ophthalmol. 2019 May 2;2019:4146124. doi: 10.1155/2019/4146124. eCollection 2019.
3
Improved systemic safety and risk-benefit ratio of topical 0.1% timolol hydrogel compared with 0.5% timolol aqueous solution in the treatment of glaucoma.
Graefes Arch Clin Exp Ophthalmol. 2006 Nov;244(11):1491-6. doi: 10.1007/s00417-006-0328-0. Epub 2006 Apr 21.
4
Comparison of a non-preserved 0.1% T-Gel eye gel (single dose unit) with a preserved 0.1% T-Gel eye gel (multidose) in ocular hypertension and glaucomatous patients.未保存的0.1%煤焦油香波眼凝胶(单剂量单位)与保存的0.1%煤焦油香波眼凝胶(多剂量)在高眼压症和青光眼患者中的比较。
Br J Ophthalmol. 2006 May;90(5):574-8. doi: 10.1136/bjo.2005.080424.