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一项比较贝美前列素 0.01%或曲伏前列素/噻吗洛尔在曾用拉坦前列素和噻吗洛尔降低眼内压的患者中的随机、前瞻性研究。

A randomized, prospective study of bimatoprost 0.01% or travoprost/timolol in patients previously treated with latanoprost and timolol to reduce intraocular pressure.

机构信息

Department of Surgery, Royal Victoria Regional Health Center , Barrie, Ontario, Canada .

出版信息

J Ocul Pharmacol Ther. 2013 Dec;29(10):876-81. doi: 10.1089/jop.2013.0108. Epub 2013 Sep 26.

DOI:10.1089/jop.2013.0108
PMID:24070367
Abstract

PURPOSE

To compare the efficacy and safety of bimatoprost 0.01% with the fixed combination travoprost 0.004%/timolol 0.5% in subjects with stable intraocular pressure (IOP) control on latanoprost and timolol.

METHODS

This was a randomized, prospective, investigator masked, crossover study comparing bimatoprost 0.01% with travoprost/timolol in 40 subjects diagnosed with primary open-angle glaucoma. Subjects were randomized to bimatoprost 0.01% qpm or travoprost/timolol qam and followed for 12 weeks, at which time they were crossed over to the alternate medication and followed for another 12 weeks. Intraocular pressure and hyperemia (rated on a standardized, 5-point photographic scale) were evaluated as change from baseline to 12 weeks following each therapy, and subject preference was elicited at the end of the study.

RESULTS

Both treatments were well tolerated and the majority of patients achieved effective IOP control relative to baseline. After 12 weeks of treatment, mean reductions from baseline IOP were -1.68 mmHg OD (right eye) and -1.58 mmHg OS (left eye) with bimatoprost and -0.45 mmHg OD and -0.53 mmHg OS with travoprost/timolol, although the differences between drugs were not statistically significant. Hyperemia scores were significantly higher with the fixed combination of travoprost/timolol than bimatoprost 0.01% as measured at 8 am (both P<0.01). Subject preference at the end of the study was more than 3 to 1 in favor of bimatoprost, with most citing greater tolerability.

CONCLUSION

Bimatoprost 0.01% and travoprost/timolol are both effective at reducing IOP in subjects with stable IOP control on latanoprost and timolol, but bimatoprost 0.01% is associated with less hyperemia.

摘要

目的

比较 0.01%贝美前列素与固定联合制剂 0.004%曲伏前列素/0.5%噻吗洛尔在对拉坦前列素和噻吗洛尔控制眼压稳定的患者中的疗效和安全性。

方法

这是一项随机、前瞻性、研究者设盲、交叉研究,比较 40 例原发性开角型青光眼患者 0.01%贝美前列素与曲伏前列素/噻吗洛尔。受试者随机分为 0.01%贝美前列素 qpm 或曲伏前列素/噻吗洛尔 qam,并随访 12 周,此时交叉至另一药物,并再随访 12 周。眼压和充血(按标准化的 5 分摄影量表评估)作为每种治疗后 12 周的基线变化进行评估,并在研究结束时得出患者的选择偏好。

结果

两种治疗均耐受良好,大多数患者与基线相比实现了有效的眼压控制。治疗 12 周后,右眼和左眼的平均眼压降低分别为贝美前列素组-1.68mmHg 和-1.58mmHg,曲伏前列素/噻吗洛尔组-0.45mmHg 和-0.53mmHg,但药物间差异无统计学意义。固定联合制剂曲伏前列素/噻吗洛尔的充血评分明显高于 0.01%贝美前列素,8 点时两者的差异均具有统计学意义(均 P<0.01)。研究结束时,超过 3 比 1 的患者选择了贝美前列素,多数患者表示其耐受性更好。

结论

0.01%贝美前列素和曲伏前列素/噻吗洛尔均可有效降低拉坦前列素和噻吗洛尔控制眼压稳定的患者的眼压,但 0.01%贝美前列素引起的充血更少。

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