Gamma-linolenic acid treatment of rheumatoid arthritis - A randomized, placebo-controlled trial
Gamma-linolenic acid treatment of rheumatoid arthritis - A randomized, placebo-controlled trial
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DOI：
10.1002/art.1780391106
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发表时间：
1996-11-01
影响因子：
--
通讯作者：
Laposata, M
中科院分区：
文献类型：
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作者：
Zurier, RB;Rossetti, RG;Laposata, M
目标。目的：观察γ -亚麻酸（GLA）对类风湿关节炎（RA）的临床疗效和不良反应。GLA是一种植物籽油衍生的不饱和脂肪酸，可抑制动物模型的炎症和关节组织损伤。在为期6个月的GLA与安慰剂双盲试验中，56名活动性RA患者被随机分为治疗组。随后进行了为期6个月的单盲试验，期间所有患者均接受GLA治疗。患者接受2.8克/天的游离脂肪酸GLA或相同胶囊的葵花籽油（安慰剂）治疗。GLA治疗6个月导致RA患者疾病活动的体征和症状有统计学意义和临床相关的减少，GLA治疗组总体有意义的反应（4项措施至少改善25%）也更好（22例患者中有14例，安慰剂组19例中有4例；P = 0.015）。在第二个6个月，两组患者的疾病活动度均有所改善。因此，在整个研究期间服用GLA的患者在第二个6个月内表现出进行性改善，在该组中，21例患者中有16例在12个月时与研究开始时相比表现出有意义的改善。本研究中使用的剂量GLA是一种耐受性良好且有效的治疗活动性RA的方法。GLA是几种植物籽油的组成部分，通常服用的剂量远低于本试验中使用的剂量，它在美国未被批准用于任何疾病的治疗，也不应被视为任何疾病的治疗方法。对其在类风湿性关节炎中的应用进行进一步的对照研究是有必要的。
Objective. To assess the clinical efficacy and adverse effects of gamma-linolenic acid (GLA), a plant seed oil-derived unsaturated fatty acid that suppresses inflammation and joint tissue injury in animal models, in the treatment of active rheumatoid arthritis (RA).Methods. Fifty-six patients with active RA were randomized to treatment groups in a 6-month, double-blind trial of GLA versus placebo. This was followed by a 6-month, single-blind trial during which all patients received GLA. Patients were treated with 2.8 gm/day of GLA as the free fatty acid or with sunflower seed oil (placebo) administered in identical capsules.Results. Treatment with GLA for 6 months resulted in statistically significant and clinically relevant reductions in the signs and symptoms of disease activity in patients with RA, Overall meaningful responses (at least 25% improvement in 4 measures) were also better in the GLA treatment group (14 of 22 patients versus 4 of 19 in the placebo group; P = 0.015). During the second 6 months, both groups exhibited improvement in disease activity. Thus, patients taking GLA during the entire study showed progressive improvement during the second 6 months, In this group, 16 of 21 patients showed meaningful improvement at 12 months compared with study entry.Conclusion. GLA at doses used in this study is a well-tolerated and effective treatment for active RA. GLA is available as a component of several plant seed oils and is usually taken in far lower doses than were used in this trial, It is not approved in the United States for the treatment of any condition, and should not be viewed as therapy for any disease. Further controlled studies of its use in RA are warranted.