| 引用本文: | 包志淑,瞿佳,方爱武,董仰曾,孙伟,富名水,王林农,管怀进,吕红彬,张明昌,秦南.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[J].中国现代应用药学,2016,33(6):807-810. |
| BAO Zhishu,QU Jia,FANG Aiwu,DONG Yangzeng,SUN Wei,FU Mingshui,WANG Linnong,GUAN Huaijin,LYU Hongbin,ZHANG Mingchang,QIN Nan.Multicenter Clinical Trial with Timolol Maleate Sustained-release Eye Drop (New) in Treatment of Primary Open Angle Glaucoma[J].Chin J Mod Appl Pharm(中国现代应用药学),2016,33(6):807-810. |
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| 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 |
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包志淑1, 瞿佳2, 方爱武2, 董仰曾3, 孙伟4, 富名水5, 王林农6, 管怀进7, 吕红彬8, 张明昌9, 秦南10
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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
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| 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。 |
| 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 |
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| 基金项目:“重大新药创制”国家科技重大专项(2014ZX09303301) |
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| Multicenter Clinical Trial with Timolol Maleate Sustained-release Eye Drop (New) in Treatment of Primary Open Angle Glaucoma |
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BAO Zhishu1, QU Jia2, FANG Aiwu2, DONG Yangzeng3, SUN Wei4, FU Mingshui5, WANG Linnong6, GUAN Huaijin7, LYU Hongbin8, ZHANG Mingchang9, QIN Nan10
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1.The Eye Hospital of Wenzhou Medical University, National Institute for Drug Clinical Trial, Wenzhou 325000, China;2.The Eye Hospital of Wenzhou Medical University, Department of Ophthalmology, Wenzhou 325000, China;3.Department of Ophthalmology, Henan Eye Institute, Zhengzhou 450003, China;4.Department of Ophthalmology, Qingdao Eye Hospital, Qingdao 266071, China;5.Department of Ophthalmology, Shanghai First People’s Hospital, Shanghai 200081, China;6.Department of Ophthalmology, Nanjing First Hospital, Nanjing 210006, China;7.Department of Ophthalmology, Affiliated Hospital of Nantong University, Nantong 226017, China;8.Department of Ophthalmology, Affiliated Hospital of Luzhou Medical College, Luzhou 646000, China;9.Department of Ophthalmology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China;10.Department of Ophthalmology, He Eye Hospital, Shenyang 110034, China
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| Abstract: |
| 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. |
| Key words: Timolol Maleate Sustained-release Eye Drop(new) primary open angle glaucoma clinical trial safety efficacy |
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