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Rho 激酶抑制剂利匹司特在现有治疗方案基础上的附加或替代治疗一年的疗效和安全性评估:一项回顾性研究。

One-Year Efficacy and Safety Assessment of Ripasudil, a Rho Kinase Inhibitor, in an Addition to or Replacing Existing Treatment Regimens: A Retrospective Study.

机构信息

Department of Ophthalmology, Toho University Ohashi Medical Center, Tokyo, Japan.

出版信息

J Ocul Pharmacol Ther. 2020 Sep;36(7):512-521. doi: 10.1089/jop.2019.0089. Epub 2020 May 15.

Abstract

To evaluate efficacy and safety of ripasudil for 1 year in addition to or replacing existing treatment regimens. We retrospectively reviewed the medical records for 128 eyes of 128 glaucoma patients who were prescribed ripasudil as an addition to or a switch from their preexisting antiglaucoma instillations. We investigated the rate and factors for discontinuation and intraocular pressure (IOP) reduction. Almost half of the patients (60 eyes) discontinued ripasudil treatment before the 1 year mark, while remaining patients completed the treatment. The lack of efficacy and development of adverse effects were significantly correlated with discontinuation ( < 0.001) in the Cox proportional hazards model. In the Kaplan-Meier curve, adverse effects occurred in earlier phase and almost 60% dropped out within 3 months after ripasudil administration. However, adverse effects also occurred randomly throughout the study period. In patients who continued ripasudil, the mean IOPs (mmHg) at baseline, 6 and 12 months after treatment were 17.7 ± 5.1, 14.6 ± 5.0, and 14.8 ± 3.8 in the Addition group, and 17.8 ± 4.1, 15.4 ± 3.2, and 15.4 ± 5.0 in the Switch group, respectively (all values <0.05). Almost half of the patients discontinued ripasudil owing to the lack of efficacy and the generation of adverse effects within the 1 year. In the remaining half, the addition and switching of ripasudil to the existing glaucoma treatment effectively reduced IOP for 1 year.

摘要

评估 ripasudil 在现有治疗方案基础上的附加或替代治疗方案,使用 1 年的疗效和安全性。我们回顾性分析了 128 例青光眼患者的 128 只眼的病历资料,这些患者被处方 ripasudil 作为附加治疗或替代其原有的抗青光眼滴眼剂。我们调查了停药率和眼压(IOP)降低率,以及停药的原因。几乎一半的患者(60 只眼)在 1 年之前停止了 ripasudil 治疗,而其余患者完成了治疗。Cox 比例风险模型显示,缺乏疗效和不良反应的发展与停药显著相关( < 0.001)。在 Kaplan-Meier 曲线中,不良反应发生在早期阶段,约 60%的患者在 ripasudil 给药后 3 个月内停药。然而,不良反应也在整个研究期间随机发生。在继续使用 ripasudil 的患者中,附加治疗组治疗前、治疗后 6 个月和 12 个月的平均 IOP(mmHg)分别为 17.7±5.1、14.6±5.0 和 14.8±3.8,转换治疗组分别为 17.8±4.1、15.4±3.2 和 15.4±5.0(所有 P 值均 <0.05)。几乎一半的患者在 1 年内由于缺乏疗效和不良反应而停止使用 ripasudil。在剩下的一半患者中,ripasudil 的附加和转换治疗有效地将 IOP 降低了 1 年。

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