Lutein supplementation in retinitis pigmentosa: PC-based vision assessment in a randomized double-masked placebo-controlled clinical trial [NCT00029289].
Lutein supplementation in retinitis pigmentosa: PC-based vision assessment in a randomized double-masked placebo-controlled clinical trial [NCT00029289].
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DOI：
10.1186/1471-2415-6-23
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发表时间：
2006-06-07
影响因子：
2
通讯作者：
Dagnelie, Gislin
中科院分区：
文献类型：
--
作者：
Bahrami, Hossein;Melia, Michele;Dagnelie, Gislin
背景：没有普遍接受的药物或手术治疗来阻止色素性视网膜炎的进展。先前的研究表明叶黄素是一种潜在的治疗方法，对黄斑色素密度有积极的影响。本研究的目的是探讨补充叶黄素对色素性视网膜炎 (RP) 患者视觉功能保存的影响。 方法：在一项采用交叉设计的双盲随机安慰剂对照 I/II 期临床试验中，34 名 RP 成年患者被随机分为两组。一组由 16 名参与者组成，在前 24 周接受叶黄素补充剂（10 毫克/天，持续 12 周，随后 30 毫克/天），然后在接下来的 24 周服用安慰剂，而另一组包括 18 名参与者，他们在叶黄素之前服用安慰剂（24 周）。使用基于 PC 的家庭测试在基线和每周的不同照明水平下测量视力、对比敏感度和中心视野。 结果：对于正常照明水平下的视力 (VA)，叶黄素治疗降低了 logMAR，即改善了 VA，但这种效果并不具有统计学意义。正常 (100%)、低 (4%) 和极低 (0.1%) 照度 log CS 的变化不具有统计显着性（p 值分别为 0.34、0.23 和 0.32）。叶黄素对视野具有统计上显着的影响（p 值：0.038），并且假设叶黄素的作用延迟 6 周，该影响在模型中会增加。将视力指标的发展与预计在 48 周内发生的自然损失进行比较，大多数指标显示下降幅度有所减少，并且这些下降对于正常照明 VA 和 CS 而言非常显着。 结论：这些结果表明，叶黄素补充剂改善了视野，也可能略微改善视力，但应谨慎解释这些结果。作为一期和二期联合临床试验，这项研究证明了叶黄素补充剂的有效性和安全性。
BACKGROUND: There is no generally accepted medical or surgical treatment to stop the progressive course of retinitis pigmentosa. Previous studies have suggested lutein as a potential treatment with positive effects on macular pigment density. The objective of this study was to examine the effect of lutein supplementation on preservation of visual function in patients with retinitis pigmentosa (RP) METHODS: In a double-masked randomized placebo-controlled phase I/II clinical trial with a cross-over design, 34 adult patients with RP were randomized to two groups. One group, consisted of 16 participants, received lutein supplementation (10 mg/d for 12 wks followed by 30 mg/d) for the first 24 weeks and then placebo for the following 24 weeks, while the other group included 18 participants for whom placebo (24 weeks) was administered prior to lutein. Visual acuity, contrast sensitivity, and central visual field were measured at different illumination levels at baseline and every week using a PC-based test at home.RESULTS: For visual acuity (VA) at normal illumination level, treatment with lutein reduced logMAR, i.e. improved VA, but this effect was not statistically significant. The changes in normal (100%), low (4%), and very low (0.1%) illumination log CS were not statistically significant (p-values: 0.34, 0.23, and 0.32, respectively). Lutein had a statistically significant effect on visual field (p-value: 0.038) and this effect increased in the model assuming a 6-week delay in effect of lutein. Comparing the development of vision measures against the natural loss expected to occur over the course of 48 weeks, most measures showed reduced decline, and these reductions were significant for normal illumination VA and CS.CONCLUSION: These results suggest that lutein supplementation improves visual field and also might improve visual acuity slightly, although these results should be interpreted cautiously. As a combined phase I and II clinical trial, this study demonstrated the efficacy and safety of lutein supplementation.