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中国原发性开角型青光眼和高眼压症患者应用 0.03%比马前列素降低眼压的疗效和安全性。

Intraocular pressure-lowering efficacy and safety of bimatoprost 0.03% therapy for primary open-angle glaucoma and ocular hypertension patients in China.

机构信息

Eye & ENT Hospital, Shanghai Medical College, Fudan University, Fenyang Road 83, Shanghai, Xuhui District 200031, China.

出版信息

BMC Ophthalmol. 2014 Feb 25;14:21. doi: 10.1186/1471-2415-14-21.

Abstract

BACKGROUND

To report the clinical outcomes in Chinese patients with primary open-angle glaucoma and ocular hypertension treated with bimatoprost 0.03% therapy.

METHODS

Two hundred sixty-three Chinese patients with primary open-angle glaucoma and ocular hypertension who needed initial or additional intraocular pressure (IOP) lowering were recruited in this prospective, open-label, multicenter clinical study and were treated with bimatoprost 0.03%. Patients received bimatoprost 0.03% as initial, replacement or adjunctive IOP-lowering therapy, and follow-up visits were performed at week 1, and month 1 and 3 of the bimatoprost treatment. The efficacy outcome measure was the post-treatment IOP level. The safety outcome measures included the rate of medication-related symptoms, physical signs, reported adverse events, and the level of conjunctival hyperemia.

RESULTS

Among 240 patients who could be categorized by pre-existing therapies and the bimatoprost therapy regimen in the study, IOP values observed in all medication conditions showed significant IOP reduction at all study visits compared with baseline. At 3 months, 8.0 ± 3.7 mmHg (32.0%) reduction in IOP was observed in treatment-naive patients after bimatoprost monotherapy; in the patients previously on various therapy regimens, 1.9 ± 2.8 mmHg (9.5%) to 6.4 ± 6.1 mmHg (24.8%) additional IOP lowering was achieved after switching to bimatoprost monotherapy or bimatoprost combination therapy. The most common adverse event was conjunctival hyperemia, mainly of trace and mild intensity.

CONCLUSIONS

Our results show that bimatoprost 0.03% was effective in lowering IOP with favorable safety in Chinese primary open-angle glaucoma and ocular hypertension patients.

摘要

背景

报告用贝美前列素 0.03%治疗中国人原发性开角型青光眼和高眼压症的临床疗效。

方法

本前瞻性、开放标签、多中心临床研究共招募了 263 例需要初始或附加降眼压的中国人原发性开角型青光眼和高眼压症患者,用贝美前列素 0.03%治疗。患者接受贝美前列素 0.03%作为初始、替代或附加降眼压治疗,治疗后第 1 周、第 1、3 个月随访。疗效指标为治疗后眼压水平。安全性指标包括药物相关症状、体征、报告的不良事件发生率和结膜充血程度。

结果

在可根据既往治疗和研究中贝美前列素治疗方案分类的 240 例患者中,所有药物条件下观察到的眼压值在所有研究访视中与基线相比均显著降低。在 3 个月时,贝美前列素单药治疗的初治患者眼压下降 8.0±3.7mmHg(32.0%);在既往接受各种治疗方案的患者中,转换为贝美前列素单药或贝美前列素联合治疗后眼压进一步下降 1.9±2.8mmHg(9.5%)至 6.4±6.1mmHg(24.8%)。最常见的不良事件是结膜充血,主要为轻度至中度。

结论

我们的结果表明,贝美前列素 0.03%可有效降低中国人原发性开角型青光眼和高眼压症患者的眼压,安全性良好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07d9/3943806/4d560a312374/1471-2415-14-21-1.jpg

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