意大利儿童青光眼研究（GIPSy）：1年结果

The Glaucoma Italian Pediatric Study (GIPSy): 1-Year Results.

作者信息

Quaranta Luciano, Biagioli Elena, Riva Ivano, Galli Francesca, Poli Davide, Rulli Eliana, Katsanos Andreas, Longo Antonio, Uva Maurizio G, Torri Valter, Weinreb Robert N

机构信息

*Department of Medical and Surgical Specialties Section of Ophthalmology, University of Brescia, Brescia †Laboratory of Methodology for Clinical Research, IRCCS-Institute for Pharmacological research Mario Negri, Milan §Department of Ophthalmology, University of Catania, Catania, Italy ‡Department of Ophthalmology, University of Ioannina, Ioannina, Greece ∥Department of Ophthalmology, Hamilton Glaucoma Center, Shiley Eye Institute, the, University of California, San Diego, CA.

出版信息

J Glaucoma. 2017 Nov;26(11):987-994. doi: 10.1097/IJG.0000000000000773.

DOI:10.1097/IJG.0000000000000773

PMID:28957960

Abstract

PURPOSE

To investigate the efficacy and safety of a treatment strategy with latanoprost and dorzolamide in primary pediatric glaucoma patients partially responsive to surgery.

PATIENTS AND METHODS

Children with primary pediatric glaucoma having postsurgical untreated intraocular pressure (IOP) between 22 and 26 mm Hg were eligible. At baseline, patients were administered latanoprost once daily. Depending on IOP reduction, patients were allocated to continuation of latanoprost monotherapy or addition of dorzolamide twice daily, or switch to dorzolamide monotherapy 3 times daily. Patients in the dorzolamide monotherapy group with IOP reduction <20% from baseline were considered nonresponders. The primary endpoint was the percentage of responders. Study treatment continued for 3 years or until treatment failure. The present article reports the 1-year analysis results.

RESULTS

A total of 35 patients (57 eyes) were analyzed. The mean age was 4.0 years (SD, 3.8). In total, 51 eyes were included in the efficacy analysis. In total, 43 eyes (84.3%; 95% confidence interval, 74.3-94.3) were considered responders: 29 on latanoprost monotherapy, 11 on the latanoprost/dorzolamide combination, and only 3 on the dorzolamide monotherapy. The efficacy of pharmacological treatment was inversely related to the age at the time of surgery. IOP reduction was 8.7 mm Hg (SD, 2.2) for latanoprost, 7.5 mm Hg (SD, 1.4) for the latanoprost/dorzolamide combination, and 8.7 mm Hg (SD, 2.1) for the dorzolamide monotherapy. Only mild or moderate local adverse events were noted. None of the patients was withdrawn due to adverse events.

CONCLUSION

Latanoprost alone or in combination with dorzolamide is safe and highly effective in lowering IOP in children postsurgery. Nonresponders were mainly patients with early presentation of the disease.

摘要

目的

探讨拉坦前列素和多佐胺联合治疗策略对部分手术治疗效果欠佳的原发性儿童青光眼患者的疗效和安全性。

患者与方法

纳入术后未治疗眼压（IOP）在22至26 mmHg之间的原发性儿童青光眼患儿。基线时，患者每日使用一次拉坦前列素。根据眼压降低情况，患者被分配至继续单药使用拉坦前列素或加用每日两次多佐胺，或改为每日三次多佐胺单药治疗。多佐胺单药治疗组中眼压较基线降低<20%的患者被视为无反应者。主要终点为有反应者的百分比。研究治疗持续3年或直至治疗失败。本文报告1年分析结果。

结果

共分析35例患者（57只眼）。平均年龄为4.0岁（标准差，3.8）。总计51只眼纳入疗效分析。总计43只眼（84.3%；95%置信区间，74.3 - 94.3）被视为有反应者：29只眼接受拉坦前列素单药治疗，11只眼接受拉坦前列素/多佐胺联合治疗，仅3只眼接受多佐胺单药治疗。药物治疗的疗效与手术时年龄呈负相关。拉坦前列素组眼压降低8.7 mmHg（标准差，2.2），拉坦前列素/多佐胺联合治疗组眼压降低7.5 mmHg（标准差，1.4），多佐胺单药治疗组眼压降低8.7 mmHg（标准差，2.1）。仅观察到轻度或中度局部不良事件。无患者因不良事件退出研究。