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Effectiveness and safety of tafluprost in primary open-angle glaucoma and ocular hypertension: a post-marketing phase IV study in China

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机构: [1]Fudan Univ, Eye & ENT Hosp, Shanghai Med Coll, Dept Ophthalmol & Visual Sci, Shanghai 200031, Peoples R China [2]Nanjing Med Univ, Dept Ophthalmol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R China [3]Capital Med Univ, Beijing Tongren Hosp, Beijing Tongren Eye Ctr, Beijing Ophthalmol & Visual Sci Key Lab, Beijing 100730, Peoples R China [4]Zhejiang Univ, Affiliated Hosp 2, Eye Ctr, Sch Med, Hangzhou 310009, Zhejiang, Peoples R China [5]Kunming Med Univ, Dept Ophthalmol, Affiliated Hosp 1, Kunming 650031, Yunnan, Peoples R China [6]Nankai Univ, Tianjin Eye Hosp, Tianjin Eye Inst, Tianjin Key Lab Ophthalmol & Visual Sci,Affiliate, Tianjin 300020, Peoples R China [7]Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Dept Ophthalmol, Wuhan 430030, Hubei, Peoples R China [8]Harbin Med Univ, Affiliated Hosp 2, Dept Ophthalmol, Harbin 150001, Heilongjiang, Peoples R China [9]Shanghai Jiao Tong Univ, Dept Ophthalmol, Xinhua Hosp, Sch Med, Shanghai 200092, Peoples R China [10]Shandong Univ, Qilu Hosp, Cheeloo Coll Med, Dept Ophthalmol, Jinan 250012, Shandong, Peoples R China [11]Wuhan Eyegood Ophthalm Hosp, Dept Cataract & Glaucoma, Wuhan 430064, Hubei, Peoples R China
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关键词: Tafluprost Primary open-angle glaucoma Ocular hypertension Clinical trial Phase IV China

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Background Prostaglandin analogs (PGAs) are the first-line treatment for primary open-angle glaucoma (POAG) and ocular hypertension (OH). This study aimed to confirm the effectiveness and safety of Tapros (R) (0.0015% tafluprost eye drops) in Chinese patients with POAG and OH. Methods This phase IV, multicenter, non-comparative, prospective study enrolled patients with POAG and OH in China between 12/27/2017 and 04/15/2020. Patients who were treatment-naive or untreated within one month (group A) or with unreached intraocular pressure (IOP) target after previous monotherapy of other PGAs (group B) or non-PGA IOP-lowering drugs (group C) were treated with 0.0015% tafluprost for three months. The IOP reduction, response rate, and safety were observed. Results There were 165, 89, and 31 patients in groups A, B, and C, with baseline IOPs of 22.4 +/- 4.7, 21.0 +/- 3.5, and 22.5 +/- 3.2 mmHg, respectively. The least-square means and percentages of IOP reduction at 3 months for groups A, B, and C were 4.7 (19.8%), 1.6 (6.1%), and 4.6 mmHg (20.3%), respectively. A significant reduction in IOP was observed at each visit compared with baseline (all P < 0.05). At the final visit, 57.0% of the participants in group A achieved an IOP reduction of >= 20%, while 40.4% and 77.4% in groups B and C achieved an IOP reduction of >= 10%. Fifty-eight treatment-related adverse events occurred in 46 participants (15.7%), of which the most common one was conjunctival hyperemia (34/293, 11.6%). Conclusions Tafluprost showed a sustained and significant effect with tolerable adverse events in Chinese patients with POAG and OH who were treatment-naive or untreated within one month or received prior treatments with unsatisfying outcomes.

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出版当年[2023]版:
大类 | 4 区 医学
小类 | 3 区 眼科学
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大类 | 4 区 医学
小类 | 3 区 眼科学
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Q3 OPHTHALMOLOGY
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Q3 OPHTHALMOLOGY

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第一作者机构: [1]Fudan Univ, Eye & ENT Hosp, Shanghai Med Coll, Dept Ophthalmol & Visual Sci, Shanghai 200031, Peoples R China
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