G Dagnelie, I S Zorge, T M McDonald作了题目为：研究叶黄素提高视网膜色素变性患者的视功能的研究，论文发表于:《Journal of the American Optometric Association 》(71(3):147-1642000)。研究目的:验证补充叶黄素对视敏度、中心视野以及对视网膜色素变性(ＲＰ)患者的视力影响。方法是:通过电子邮件向全球招募参与者。16名参与者(13名ＲＰ患者，3名其他视网膜炎患者)经过26周补充叶黄素(前9周40mg/天，以后20mg/天)，参与者通过电脑屏幕自测视敏度和墙上的挂图自测中心视野的扩展。结果:参与者的视敏度平均提高0.75dB，中心视野只有原来补充过叶黄素的患者能大大提高(0.55dB)。

结论:补充叶黄素短期内可以提高RP患者的视力。

以下是论文摘要：

补充叶黄素对保存视网膜色素变性视功能的作用

The Effect of Lutein Supplementation in Preservation of Visual Function in Retinitis Pigmentosa; A Randomized Double–Blind Placebo–Controlled Clinical Trial

补充叶黄素对保存视网膜色素变性（RP）患者视力的效果：随机、双盲、对照临床实验

H. Bahrami, M. Melia, L. Yang, J. Stone, D. Bourdeau, F. Eshraghi, D. Malde novich and G. Dagnelie

Wilmer Eye Institute, Department of Ophthalmology, Johsn Hopkins University, Baltimore, MD

Commercial Relationships: H. Bahrami, None; M. Melia, None; L. Yang, None; J. Stone, None; D. Bourdeau, None; F. Eshraghi, None; D. Maldenovich, None; G. Dagnelie, None.

Grant Identification: NEI Grant R03 EY 14416 and NCCAM Grant R21 AT00292
（机构及作者简介，主要为美国约翰-霍普斯金大学眼科研究所的成员）
Abstract

摘要

Purpose: To evaluate the effectiveness of lutein supplementation in preventing progressive vision loss in patients with retinitis pigmentosa (RP)

目的：评估补充叶黄素对防止视网膜色素变性（RP）患者视力退行性丧失的效果

Methods: Started in May 2001, as a combined phase I/II trial, 45 adult patients with retinitis pigmentosa were enrolled in this cross–over trial and randomized to two groups.

方法：实验从2001年5月开始，分I/II期，45名成年RP患者参加，随机分成两组。

One group received lutein supplementation and for 24 weeks (0 mg/d/PO for 12wks followed by 30 mg/d/PO) and then placebo for 24 weeks, Washout Group.

一组服用叶黄素产品24周（0mg/d/PO 12周，接着30mg/d/PO），然后服用安慰剂24周，washout组。

In the other group, Buildup Group, placebo (24 weeks) was administered prior to lutein.

另外一组，Buildup组，先服用安慰剂（24周），然后服用叶黄素。

Subjects received multivitamin supplementation in addition to their lutein or placebo throughout the trial.

整个实验，受试者都补充复合维生素，不管是叶黄素还是安慰剂。

Subjects visual function was measured by multiple tests, including visual acuity, contrast sensitivity, and visual field at up to three levels of illumination at baseline and every 6 weeks in the lab.

受试者的视功能综合测试，包括视觉灵敏度、对比灵敏度、视野，在三级照明环境和每6周在实验室测试。

Also, these tests were performed every week using a previously validated PC–based test in the home.

同样，每周在家里采用之前确认的，基于PC机的方法进行测试。

Results: Data from 35 subjects are reported here, and has been analyzed using the Generalized Estimating Equations (GEE) based on intention–to–treat analysis; 16 in the Washout Group, the other 19 in the Buildup Group.

结果：35名受试者的结果如下，通过GEE分析治疗目的，16名Washout组，19名Buildup组。

Analysis showed a significant beneficial effect of lutein on visual acuity (p<0.001), while contrast sensitivity was worsened significantly (p<0.001) during lutein usage; over the full trial period, though, contrast sensitivity among all subjects improved significantly.

分析显示叶黄素对视觉灵敏度有显著效果（p<0.001），然而在叶黄素服用期间，对比灵敏度变得更差（p<0.001），整个实验过后，所有受试者的对比灵敏度都显著提高。

Lutein did not have a significant effect in preserving the visual field, but subjects in the Washout Group had significantly slower loss of visual field than those in the Buildup Group (p value: 0.02).

叶黄素对视野损失效果不是十分明显，但washout组的受试者明显比Buildup组的受试者的视野丧失慢。

No adverse effects were observed for lutein, while one patient could not tolerate multivitamin.

没有发现叶黄素有不良作用，其中有一名患者不能忍受复合维生素。

Conclusions: Lutein appears to be an effective supplement for preservation of visual function in patients with retinitis pigmentosa, which is important in view of the lack of effective intervention for these patients.

结论：补充叶黄素对保存RP 视功能是有效的，对这些患者来说，进行叶黄素干预是非常重要的。

Lutein appears to have differential effects on different components of vision loss in the same patients.

叶黄素对相同患者的不同视力指标的效果不同。

The anomalous improvement of contrast sensitivity during washout may be attributed to a delayed incorporation and effect of lutein in the retina.

对比灵敏度在washout期差异提高，可能是叶黄素在视网膜效果延迟的结果。

Since all subjects were receiving multivitamin throughout the trial, preservation of visual function may in part be attributed to multivitamin, or its combination with lutein.

由于在整个实验过程当中，所有受试者都服用了复合维生素，保存视功能可能也跟复合维生素有关，或者复合了叶黄素。

Long–term lutein and multivitamin effects on vision in RP patients need to be further investigated.

长期的叶黄素和复合维生素对RP患者的视力作用需要进一步研究。

Key Words: retinitis ? clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials ? low vision