Berson Eliot L, Rosner Bernard, Sandberg Michael A, Weigel-DiFranco Carol, Moser Ann, Brockhurst Robert J, Hayes K C, Johnson Chris A, Anderson Ellen J, Gaudio Alexander R, Willett Walter C, Schaefer Ernst J
Berman-Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School, 243 Charles Street, Boston, MA 02114, USA.
Arch Ophthalmol. 2004 Sep;122(9):1297-305. doi: 10.1001/archopht.122.9.1297.
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.
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 omega-3 fatty acid intake.
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.
No significant differences in decline in ocular function were found between the docosahexaenoic acid 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 omega-3 fatty acid intake.
In patients assigned to receive 15 000 IU/d of vitamin A, this randomized trial showed that 1200 mg/d of docosahexaenoic acid supplementation over a 4-year interval did not, on average, slow the course of disease in patients with retinitis pigmentosa.
确定治疗剂量的二十二碳六烯酸（DHA），一种ω-3脂肪酸，是否会减缓成年视网膜色素变性患者在接受维生素A治疗时视网膜变性的进程。
对221例年龄在18至55岁之间的患者进行随机、对照、双盲试验，随访4年。患者分别服用1200毫克/天的二十二碳六烯酸或对照胶囊。所有患者均服用15000国际单位/天的维生素A（以棕榈酸视黄酯形式给药）。随机分组时考虑了基因类型和基线膳食ω-3脂肪酸摄入量。
主要观察指标是Humphrey视野分析仪30-2程序的总分；次要观察指标是30-2和30/60-1程序总分的合计、30赫兹视网膜电图振幅以及糖尿病视网膜病变早期治疗研究视力。
在全部221例随机分组的患者中，以及在完成全部4次随访的208例患者中，在4年的随访期内，二十二碳六烯酸加维生素A（DHA+A）组和对照组加维生素A（对照组+A）组在眼功能下降方面均未发现显著差异。DHA+A组Humphrey视野分析仪30-2程序的平均年敏感度损失率为37分贝，对照组+A组为38分贝（P=0.88）。对于Humphrey视野分析仪30-2和30/60-1程序的合计结果，DHA+A组的平均年视野敏感度损失率为57分贝，对照组+A组为60分贝（P=0.73）。未观察到有毒不良反应。在基因类型或基线ω-3脂肪酸摄入量类别内，未观察到治疗组分配之间的显著差异。
在接受15000国际单位/天维生素A治疗的患者中，这项随机试验表明，在4年期间每天补充1200毫克二十二碳六烯酸，平均而言并不能减缓视网膜色素变性患者的疾病进程。
