新型噻吗洛尔滴眼液治疗原发性开角型青光眼有效性和安全性的临床研究  

Multicenter Clinical Trial with Timolol Maleate Sustained-release Eye Drop(New) in Treatment of Primary Open Angle Glaucoma

作　　者：包志淑[1] 瞿佳[2] 方爱武[2] 董仰曾[3] 孙伟 富名水[5] 王林农[6] 管怀进[7] 吕红彬[8] 张明昌[9] 秦南[10] 

机构地区：[1]温州医科大学附属眼视光医院国家药物临床试验机构,浙江温州325000 [2]温州医科大学附属眼视光医院眼科,浙江温州325000 [3]河南省眼科研究所眼科,郑州450003 [4]青岛眼科医院眼科,青岛266071 [5]上海市第一人民医院眼科,上海200081 [6]南京市第一医院眼科,南京210006 [7]南通大学附属医院眼科,江苏南通226017 [8]泸州医学院附属医院眼科,四川泸州646000 [9]华中科技大学同济医学院附属协和医院眼科,武汉430022 [10]沈阳何氏眼科医院眼科,沈阳110034

出　　处：《中国现代应用药学》2016年第6期807-810,共4页Chinese Journal of Modern Applied Pharmacy

基　　金："重大新药创制"国家科技重大专项(2014ZX09303301)

摘　　要：目的评价新型马来酸噻吗洛尔滴眼液治疗原发性开角型青光眼的安全性和有效性。方法以多中心、随机、双盲、阳性药平行对照的方式开展为期12周的非劣效性临床试验。240例原发性开角型青光眼患者,按1∶1分配至新型噻吗洛尔滴眼液组和普通的噻吗洛尔滴眼液,每组各120例,比较两者用药效果。结果符合方案集204例受试者,2组平均眼压治疗前后比较,差异有统计学意义(P<0.05)。用药第6周和治疗后较基线的差值组间比较,差异无统计学意义。安全集229例受试者发生不良事件32件,主要为眼部不适和心率减慢。结论与传统的噻吗洛尔滴眼液治疗原发性开角型青光眼相比,新型噻吗洛尔滴眼液疗效相似,且使用方便,值得临床推广。OBJECTIVE To evaluate the safety and efficacy of Timolol Maleate Sustained-release Eye Drop（new） in the treatment of primary open angle glaucoma. METHODS This was a 12-week multi-center, randomized, double-blind, parallel group, non-inferiority clinical trial. The trial enrolled 240 subjects with primary open angle glaucoma. Subjects were randomized to test [Timolol Maleate Sustained-release Eye Drop（new）] group and control（traditional timolol eye drops） group by 1∶1. The clinical effect of drugs in the two groups were recorded and analyzed comparatively. RESULTS There were 204 subjects in the per protocol set. These difference were statistically insignificant between pre-exposure and post-exposure average levels of lowing intraocular pressure（P〈0.05）. The comparision between two groups were revealed as no significant difference in statistics on every observation moments of time. There were 229 subjects in the safety set. The 32 cases of adverse events in the safety set mainly included eye reactions and slow heart rate. CONCLUSION The efficacy of Timolol Maleate Sustained-release Eye Drop（new） treatment in primary open angle glaucoma is similar with that of traditional timolol eye drops, and it is worthy of clinical application for its lower toxicity induced by its solvent and convenience of usage.

关 键 词：新型噻吗洛尔滴眼液 原发性开角型青光眼 临床试验 安全性 有效性 

分 类 号：R969.4[医药卫生—药理学]