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银杏叶提取物对正常眼压青光眼患者视野和对比敏感度的影响:一项随机、交叉临床试验。

Effect of Ginkgo biloba on visual field and contrast sensitivity in Chinese patients with normal tension glaucoma: a randomized, crossover clinical trial.

机构信息

State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.

出版信息

Invest Ophthalmol Vis Sci. 2014 Jan 7;55(1):110-6. doi: 10.1167/iovs.13-13168.

DOI:10.1167/iovs.13-13168
PMID:24282229
Abstract

PURPOSE

We evaluated the effect of ginkgo biloba extract on visual field defect and contrast sensitivity in a Chinese cohort with normal tension glaucoma.

METHODS

In this prospective, randomized, placebo-controlled crossover study, patients newly diagnosed with normal tension glaucoma, either in a tertiary glaucoma clinic (n = 5) or in a cohort undergoing routine general physical examinations in a primary care clinic (n = 30), underwent two 4-week phases of treatment, separated by a washout period of 8 weeks. Randomization determined whether ginkgo biloba extract (40 mg, 3 times per day) or placebo (identical-appearing tablets) was received first. Primary outcomes were change in contrast sensitivity and mean deviation on 24-2 SITA standard visual field testing, while secondary outcomes included IOP and self-reported adverse events.

RESULTS

A total of 35 patients with mean age 63.7 (6.5) years were randomized to the ginkgo biloba extract-placebo (n = 18) or the placebo-ginkgo biloba extract (n = 17) sequence. A total of 28 patients (80.0%, 14 in each group) who completed testing did not differ at baseline in age, sex, visual field mean deviation, contrast sensitivity, IOP, or blood pressure. Changes in visual field and contrast sensitivity did not differ by treatment received or sequence (P > 0.2 for all). Power to have detected a difference in mean defect as large as previously reported was 80%.

CONCLUSIONS

In contrast to some previous reports, ginkgo biloba extract treatment had no effect on mean defect or contrast sensitivity in this group of normal tension glaucoma patients. (http://www.chictr.org number, ChiCTR-TRC-08000724).

摘要

目的

我们评估了银杏叶提取物对正常眼压性青光眼中国人群视野缺损和对比敏感度的影响。

方法

在这项前瞻性、随机、安慰剂对照交叉研究中,新诊断为正常眼压性青光眼的患者(来自三级青光眼诊所[ n = 5]或初级保健诊所常规进行一般体检的队列[ n = 30])接受了为期 4 周的两阶段治疗,间隔 8 周的洗脱期。随机化决定患者是先接受银杏叶提取物(40 mg,每日 3 次)还是安慰剂(外观相同的片剂)治疗。主要结局是 24-2 SITA 标准视野测试中对比敏感度和平均偏差的变化,次要结局包括眼压和自述不良反应。

结果

共有 35 名平均年龄为 63.7(6.5)岁的患者被随机分配至银杏叶提取物-安慰剂( n = 18)或安慰剂-银杏叶提取物( n = 17)组。共有 28 名患者(80.0%,每组各 14 名)完成了测试,他们在基线时的年龄、性别、视野平均偏差、对比敏感度、眼压或血压方面没有差异。治疗方式或顺序的变化对视野和对比敏感度均无影响(所有 P 值均 > 0.2)。检测到与先前报道的平均缺损差异大小的效能为 80%。

结论

与一些先前的报告相反,银杏叶提取物治疗对这组正常眼压性青光眼患者的平均缺损或对比敏感度没有影响。(http://www.chictr.org number, ChiCTR-TRC-08000724)。

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