评价0.004%曲伏前列素/0.5%噻吗心安复合滴眼液的安全性和有效性

作     者：Barnebey H.S Orengo-Nania S Flowers B.E 杨秀梅 

作者机构：University of Washington Ophthalmology Specialty Eye Care Center Boren Avenue Seattle WA 98004 United States Dr 

出 版 物：《世界核心医学期刊文摘（眼科学分册）》 (Digest of the World Core Medical Journals:Ophthalmology)

年 卷 期：2005年第1卷第12期

页      面：4-4页

学科分类：1002[医学-临床医学] 100212[医学-眼科学] 10[医学] 

主　　题：曲伏前列素 噻吗心安 开角型青光眼 高眼压症 安慰剂 临床观察结果 双盲法 

摘      要：PURPOSE: To compare the safety and intraocular pressure (IOP)-lowering efficacy of travoprost 0.004% /timolol 0.5% fixed combination ophthalmic solution (Trav/Tim) to its components travoprost 0.004% ophthalmic solution, TRAVATAN, (Trav) and timolol 0.5% ophthalmic solution (Tim) in patients with open-angle glaucoma or ocular hypertension. DESIGN: Randomized multicenter, double-masked, active-controlled, parallel group ***: Two hundred sixty-three patientswith open-angle glaucoma or ocular hypertensionwere randomized to receive Trav/Tim once daily AM (and vehicle PM), Trav once daily PM (and vehicle AM), or Tim twice daily (AM and PM). Efficacy and safety were compared across treatment groups over 3 months. RESULTS: Trav/Tim produced a mean IOP decrease from baseline of 1.9 mmHg to 3.3 mmHg more than Tim, with a significant decrease in mean IOP at each of the nine study visits (P ≤ .003). Trav/Tim decreased mean IOP by 0.9 mm Hg to 2.4 mm Hg more than Trav, with a significant decrease in mean IOP at seven of the nine study visits (P ≤ .05). The adverse event profile for Trav/Tim was comparable to Trav or Tim alone. CONCLUSIONS: Over the 3 months of treatment, Trav/Tim produced clinically relevant IOP reductions in patients with open-angle glaucoma or ocular hypertension that were greater than those produced by either Trav or Tim alone. The clinical results that Trav/Tim was safe andwell tolerated with an incidence of adverse eventswas comparable to the results of Trav or Tim alone. Trav/Tim provides both more effective IOP reduction than its components and the benefits of once-daily dosing.