Chen Xue-Li, Fu Yan-Jing, Qu Bo, Wang Ye-Wei, Tang Xin, Wang Yu-Hong, Zhou Guo-Yi, Lin Ming-Kai, Shen Jing-Yuan, Yao Jin, Li Su-Yan, Wu Miao-Qin, Peng Hua-Zong, Lai Ming-Ying, Wu Ren-Yi, Zhang Yi-Nong, Li Yan, Wu Xiao-Jun, Zhang Ming-Chang, Guo Su-Ping, Sun Xing-Huai
Department of Ophthalmology, Eye & ENT Hospital of Fudan University, Shanghai 200000, China.
Department of Ophthalmology, Daqing Ophthalmologic Hospital, Daqing 163000, Heilongjiang Province, China.
Int J Ophthalmol. 2023 Jan 18;16(1):108-114. doi: 10.18240/ijo.2023.01.16. eCollection 2023.
To investigate the treatment pattern and safety of tafluprost for glaucoma and ocular hypertension (OH) in clinical practice in China.
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.
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).
Tafluprost is safe for POAG and OH, and tolerable when combined with other eye drops and under various clinical circumstances.
探讨在中国临床实践中他氟前列素治疗青光眼和高眼压症（OH）的治疗模式及安全性。
这项上市后观察性研究纳入了2017年9月至2020年3月期间在中国20家医院30天内接受他氟前列素降低眼压（IOP）的患者。收集他氟前列素治疗期间及治疗后30天内的药物不良反应（ADR）。
本研究共纳入2544例患者，其中58.5%（1488/2544）患有原发性开角型青光眼（POAG），21.9%（556/2544）患有高眼压症，19.7%（500/2544）因其他原因使用他氟前列素。359例ADR发生在10.1%（258/2544）的患者中，未发生严重不良事件。最常见的ADR是结膜充血（124例患者出现128例ADR，4.9%）。共有1670名参与者（65.6%）将他氟前列素与碳酸酐酶抑制剂（CAIs；37.1%，620/1670）、拟交感神经药（33.5%，559/1670）、β受体阻滞剂（33.2%，555/1670）、其他前列腺素类似物（PGAs；15.6%，260/1670）和其他滴眼液（15.1%，253/1670）联合使用。接受他氟前列素与其他PGAs联合治疗的患者结膜充血发生率最高（23例患者出现23例ADR，8.8%，23/260），与CAIs联合使用时最低（16例患者出现16例ADR，2.6%，16/620）。他氟前列素应用于原发性闭角型青光眼（41.6%，208/500）、青光眼手术后（17.8%，89/500）和非青光眼手术后（15.8%，79/500）。
他氟前列素对POAG和OH是安全的，与其他滴眼液联合使用以及在各种临床情况下均可耐受。
