Safety profile of 0.0015%tafluprost eye drops in China:a post-marketing observational study  

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作  者:Xue-Li Chen Yan-Jing Fu Bo Qu Ye-Wei Wang Xin Tang Yu-Hong Wang Guo-Yi Zhou Ming-Kai Lin Jing-Yuan Shen Jin Yao Su-Yan Li Miao-Qin Wu Hua-Zong Peng Ming-Ying Lai Ren-Yi Wu Yi-Nong Zhang Yan Li Xiao-Jun Wu Ming-Chang Zhang Su-Ping Guo Xing-Huai Sun 

机构地区:[1]Department of Ophthalmology,Eye&ENT Hospital of Fudan University,Shanghai 200000,China [2]Department of Ophthalmology,Daqing Ophthalmologic Hospital,Daqing 163000,Heilongjiang Province,China [3]Department of Ophthalmology,the Fourth Affiliated Hospital of China Medical University,Shenyang 110000,Liaoning Province,China [4]Department of Ophthalmology,Da Lian He Eye Specialist Hospital,Dalian 116000,Liaoning Province,China [5]Department of Ophthalmology,Beijing Tongren Hospital,Beijing 100000,China [6]Department of Ophthalmology,Xiamen Eye Center of Xiamen University,Xiamen 361000,Fujian Province,China [7]Department of Ophthalmology,Yueqing People’s Hospital,Wenzhou 325600,Zhejiang Province,China [8]Department of Glaucoma,Zhongshan Ophthalmic Center,Sun Yat-sen University,Guangzhou 510000,Guangdong Province,China [9]Department of Ophthalmology,Shengzhou Shen’s Eye Hospital,Shaoxing 312400,Zhejiang Province,China [10]Department of Ophthalmology,the Affiliated Eye Hospital of Nanjing Medical University,Nanjing 210000,Jiangsu Province,China [11]Department of Ophthalmology,Xuzhou No.1 Peoples Hospital,Xuzhou 221000,Jiangsu Province,China [12]Department of Ophthalmology,Zhejiang Provincial People’s Hospital,Hangzhou 310000,Zhejiang Province,China [13]Department of Ophthalmology,Wuhan Eyegood Ophthalmic Hospital,Wuhan 430014,Hubei Province,China [14]Department of Ophthalmology,Shenzhen Eye Hospital,Shenzhen 518001,Guangdong Province,China [15]Department of Glaucoma,Shanghai Heping Eye Hospital,Shanghai 200000,China [16]Department of Ophthalmology,Wuxi Second People’s Hospital,Wuxi 214000,Jiangsu Province,China [17]Department of Ophthalmology,First Affiliated Hospital of Kunming Medical University,Kunming 650000,Yunnan Province,China [18]Department of Ophthalmology,Union Shenzhen Hospital(Nanshan Hospital),Shenzhen 518000,Guangdong Province,China [19]Department of Ophthalmology,Wuhan Union Hospital,Wuhan 430000,Hubei Province,China [20]Department of Ophthalmology,Shengyang He Eye Specialist Hospital,Shenyang 11

出  处:《International Journal of Ophthalmology(English edition)》2023年第1期108-114,共7页国际眼科杂志(英文版)

基  金:Supported by Santen Pharmaceutical(China)Co.,Ltd.

摘  要:AIM:To investigate the treatment pattern and safety of tafluprost for glaucoma and ocular hypertension(OH)in clinical practice in China.METHODS:This post-marketing observational study included patients who received tafluprost to lower intraocular pressure(IOP)within 30d between September 2017 and March 2020 in 20 hospitals in China.Adverse drug reactions(ADRs)during tafluprost treatment and within 30d after the treatment were collected.RESULTS:A total of 2544 patients were included in this study,of them 58.5%(1488/2544)had primary open angle glaucoma(POAG),21.9%(556/2544)had OH and 19.7%(500/2544)used tafluprost for other reasons.Of 359 ADRs occurred in 10.1%(258/2544)patients,and no serious adverse event occurred.The most common ADR was conjunctival hyperemia(128 ADRs in 124 patients,4.9%).Totally 1670 participants(65.6%)combined tafluprost with carbonic anhydrase inhibitors(CAIs;37.1%,620/1670),sympathomimetics(33.5%,559/1670),β-blockers(33.2%,555/1670),other prostaglandin analogs(PGAs;15.6%,260/1670)and other eye drops(15.1%,253/1670).The highest incidence of conjunctival hyperemia was noted in patients who received tafluprost in combination with other PGAs(23 ADRs in 23 patients,8.8%,23/260)and the lowest was in combination with CAIs(16 ADRs in 16 patients,2.6%,16/620).Tafluprost was applied in primary angle-closure glaucoma(41.6%,208/500),after glaucoma surgery(17.8%,89/500)and after non-glaucoma surgery(15.8%,79/500).CONCLUSION:Tafluprost is safe for POAG and OH,and tolerable when combined with other eye drops and under various clinical circumstances.

关 键 词:TAFLUPROST GLAUCOMA ocular hypertension intraocular pressure adverse drug reactions 

分 类 号:R77[医药卫生—眼科]

 

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