OBJECTIVE:Prostaglandin receptor analogs lower intraocular pressure (IOP) and are used for the treatment of glaucoma. This study aimed to compare the safety, tolerability and pharmacodynamics of four doses of the new, selective-prostanoid receptor agonist, tafluprost (AFP-168) in a Phase I placebo-controlled study. METHODS:Healthy volunteers (n = 16) received sequentially ascending doses of tafluprost (0.0001%, 0.0005%, 0.0025% and 0.005%) in one eye, and placebo in the other. Each treatment period consisted of 2 days of treatment, with 5 days between the treatment periods. Safety and tolerability assessments, as well as IOP measurements, were performed at defined intervals. RESULTS:Tafluprost was generally well tolerated and no volunteer discontinued due to adverse events (AEs). The most common ocular AE was ocular hyperemia, which was mild-to-moderate, and highly concentration-dependent. All doses of tafluprost decreased IOP, with the maximum effect occurring 12 hours after treatment. The decrease in IOP relative to placebo was significantly more effective with tafluprost 0.0025% and 0.005%, compared with tafluprost 0.0001% (p pound 0.005). CONCLUSION:Tafluprost was well tolerated and effective in lowering IOP. These data support further testing of tafluprost 0.0025% and 0.005%.

译文

目的:前列腺素受体类似物可降低眼压(IOP),用于治疗青光眼。这项研究旨在在I期安慰剂对照研究中比较四种剂量的新型选择性前列腺素受体激动剂tafluprost(AFP-168)的安全性,耐受性和药效学。
方法:健康志愿者(n = 16)在一只眼睛中依次接受塔氟前列素(0.0001%,0.0005%,0.0025%和0.005%)的剂量,而另一只则接受安慰剂。每个治疗期包括2天的治疗,每个治疗期之间有5天。安全性和耐受性评估以及IOP测量均按规定的时间间隔进行。
结果:塔夫前列素一般耐受良好,没有志愿者因不良事件(AE)而停药。最常见的眼部AE是眼部充血,轻度至中度且高度依赖浓度。所有剂量的tafluprost均可降低IOP,最大作用发生在治疗后12小时。相对于安慰剂,IOP的降低在使用Tafluprost为0.0025%和0.005%时显着更有效,而在Tafluprost中为0.0001%(P磅为0.005)。
结论:Tafluprost具有良好的耐受性,可有效降低眼压。这些数据支持进一步对他氟普罗斯特进行0.0025%和0.005%的测试。

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