Clinical trial of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment
Clinical trial of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment
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DOI：
10.1001/archopht.122.9.1297
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发表时间：
2004-09-01
影响因子：
--
通讯作者：
Schaefer, E
中科院分区：
文献类型：
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作者：
Berson, EL;Rosner, B;Schaefer, E
目的：确定治疗剂量的二十二碳六烯酸(DHA)--一种omega-3脂肪酸--是否能减缓正在接受维生素A治疗的成年视网膜色素变性患者的视网膜变性进程。设计：对221名年龄在18岁至55岁之间的患者进行为期4年的随机对照双盲试验。患者被给予1200 mg/d的二十二碳六烯酸或对照胶囊。所有患者均给予15000IU/d的维生素A(以维生素A棕榈酸酯的形式给药)。随机化考虑了遗传类型和饮食w-3脂肪酸的基线摄入量。主要结果指标：主要结果指标是Humphrey视野分析仪30-2方案的总分；次要结果指标是30-2和30/60-1方案的总分、30-2和30/60-1方案的总分、30-HZ视网膜电波幅值和早期治疗糖尿病视网膜病变研究的视力。结果：在所有221名随机患者中，或在完成所有4次随访的208名患者中，二十二碳六烯酸+维生素A(DHA+A)组和对照+维生素A组之间的眼功能下降没有显著差异。Humphrey field Analyzer 30-2程序的平均年敏感度损失率在DHA+A组为37分贝，对照+A组为38分贝(P=0.88)。对于Humphrey field Analyzer 30-2和30/60-1程序，DHA+A组和对照+A组的平均每年视野敏感度损失率分别为57分贝和60分贝(P=0.73)。未观察到毒副作用。根据治疗组的分配，在基因类型或基线w-3脂肪酸摄入量类别内没有显著差异。结论：在被分配接受15000IU/d维生素A的患者中，这项随机试验表明，平均而言，在4年的间隔时间内补充1200 mg/d的二十二碳六烯酸并不能减缓视网膜色素变性患者的病程。
Objective: To determine whether a therapeutic dose of docosahexaenoic acid (DHA), an omega-3 fatty acid, will slow the course of retinal degeneration in adult patients with retinitis pigmentosa who are also receiving vitamin A.Design: Randomized, controlled, double-masked trial of 221 patients, aged 18 to 55 years, evaluated over a 4-year interval. Patients were given either 1200 mg/d of docosahexaenoic acid or control capsules. All were given 15 000 IU/d of vitamin A (given as retinyl palmitate). Randomization considered genetic type and baseline dietary w-3 fatty acid intake.Main Outcome Measures: The primary outcome measure was the total point score for the 30-2 program of the Humphrey field analyzer; secondary outcome measures were the total point score for the 30-2 and 30/60-1 programs combined, 30-Hz electroretinogram amplitude, and Early Treatment Diabetic Rentinopathy Study visual acuity.Results: No significant differences in decline in ocular function were found between the docosahexaenoicacid plus vitamin A (DHA+A) group and control plus vitamin A (control+A) group over a 4-year interval among all 221 randomized patients or among the 208 patients who completed all 4 follow-up visits. The mean annual rate of loss of sensitivity for the Humphrey Field Analyzer 30-2 program was 37 dB for the DHA+A group and 38 dB for the control+A group (P = .88). For the Humphrey Field Analyzer 30-2 and 30/60-1 programs combined, the mean annual rates of loss of field sensitivity were 57 dB for the DHA+A group and 60 dB (P = .73) for control+A group. No toxic adverse effects were observed. No significant differences by treatment group assignment were observed within genetic types or within the category of baseline w-3 fatty acid intake.Conclusion: In patients assigned to receive 15 000 IU/d of vitamin A, this randomized trial showed that 1200 mg/d of docosahexacnoic acid supplementation over a 4-year interval did not, on average, slow the course of disease in patients with retinitis pigmentosa.