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原发性开角型青光眼患者中0.1 mg/mL无防腐剂比马前列素与含苯扎氯铵的0.1 mg/mL比马前列素或0.3 mg/mL无防腐剂比马前列素的眼耐受性比较

Ocular Tolerability of Bimatoprost 0.1 mg/mL Preservative-Free versus Bimatoprost 0.1 mg/mL with Benzalkonium Chloride or Bimatoprost 0.3 mg/mL Preservative-Free in Patients with Primary Open-Angle Glaucoma.

作者信息

Filippelli Mariaelena, Campagna Giuseppe, Ciampa Nicola, Fioretto Gaetano, Giannini Roberta, Marino Pier Franco, dell'Omo Roberto, Costagliola Ciro

机构信息

Department of Medicine and Health Sciences, "V. Tiberio", University of Molise, 86100 Campobasso, Italy.

Department of Medical-Surgical Sciences and Translational Medicine, University of Rome "Sapienza", 00185 Rome, Italy.

出版信息

J Clin Med. 2022 Jun 19;11(12):3518. doi: 10.3390/jcm11123518.

Abstract

This study aimed to evaluate whether the therapeutic switch from a formulation of Bimatoprost 0.1 mg/mL with benzalkonium chloride (BAK) or Bimatoprost 0.3 mg/mL preservative-free to a formulation of Bimatoprost 0.1 mg/mL preservative-free could improve eye surface conditions in patients with glaucoma; intraocular pressure (IOP) was also evaluated. All patients meeting the inclusion criteria were eligible for the therapeutic switch to Bimatoprost 0.1 mg/mL preservative-free. At each check visit, enrolled patients underwent a break-up time (BUT) test, an ocular surface disease index (OSDI) test, and a three-point tonometric curve. A total of 40 patients were enrolled (23 were in therapy with Bimatoprost 0.1 mg/mL with BAK and 17 with Bimatoprost 0.3 mg/mL preservative-free). Significant differences of OSDI and BUT between Bimatoprost 0.1 mg/mL with BAK at baseline vs. Bimatoprost 0.1 mg/mL preservative-free at 14 and 28 days (p < 0.0001 and p = 0.0003, respectively) were recorded. Similarly, significant differences of OSDI and BUT between Bimatoprost 0.3 mg/mL preservative-free at baseline vs. Bimatoprost 0.1 mg/mL preservative-free at 14 and 28 days (p < 0.0001 for both) were found. Bimatoprost 0.1 mg/mL preservative-free has a better tolerability profile associated with non-therapeutical inferiority in the control of IOP compared to the other Bimatoprost formulations.

摘要

本研究旨在评估从含苯扎氯铵(BAK)的0.1 mg/mL比马前列素制剂或不含防腐剂的0.3 mg/mL比马前列素制剂转换为不含防腐剂的0.1 mg/mL比马前列素制剂是否能改善青光眼患者的眼表状况;同时还评估了眼压(IOP)。所有符合纳入标准的患者均有资格转换为使用不含防腐剂的0.1 mg/mL比马前列素进行治疗。在每次复诊时,入组患者均接受泪膜破裂时间(BUT)测试、眼表疾病指数(OSDI)测试以及三点眼压曲线测量。总共入组了40例患者(23例使用含BAK的0.1 mg/mL比马前列素进行治疗,17例使用不含防腐剂的0.3 mg/mL比马前列素进行治疗)。记录到在基线时含BAK的0.1 mg/mL比马前列素与14天和28天时不含防腐剂的0.1 mg/mL比马前列素之间,OSDI和BUT存在显著差异(分别为p < 0.0001和p = 0.0003)。同样,在基线时不含防腐剂的0.3 mg/mL比马前列素与14天和28天时不含防腐剂的0.1 mg/mL比马前列素之间,OSDI和BUT也存在显著差异(两者均为p < 0.0001)。与其他比马前列素制剂相比,不含防腐剂的0.1 mg/mL比马前列素具有更好的耐受性,且在眼压控制方面无治疗劣势。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbfc/9224644/67cd40403694/jcm-11-03518-g001.jpg

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