n-3 Fatty Acid Supplementation for the Treatment of Dry Eye Disease
n-3 Fatty Acid Supplementation for the Treatment of Dry Eye Disease
复制标题
DOI：
10.1056/nejmoa1709691
复制
发表时间：
2018-05-03
影响因子：
158.5
通讯作者：
中科院分区：
文献类型：
--
作者：
背景眼病是一种常见的慢性疾病，以眼睛不适和视力障碍为特征，降低生活质量。许多临床医生建议使用n-3脂肪酸(通常称为omega-3脂肪酸)的补充剂来缓解症状。方法在一项多中心双盲临床试验中，我们随机分配中重度干眼病患者每天服用3000毫克鱼源性n-3二十碳五烯酸和二十二碳六烯酸(活性补充组)或橄榄油安慰剂(安慰剂组)。主要结果是眼表疾病指数(OSDI；得分从0到100，得分越高，表明症状越严重)得分与基线相比的平均变化，这是基于6个月和12个月时得分的平均值。次要结果包括每只眼睛结膜染色分数(从0到6)和角膜染色分数(从0到15)的平均变化，分数越高表明眼表损伤越严重，以及泪液破裂时间(眨眼和泪膜缝隙之间的秒数)和席尔默测试结果(下眼皮上纸条的湿润长度)的平均变化，较低的数值表明症状更严重。结果总共有349名患者被分配到积极补充组和186名安慰剂组；初步分析分别包括329名和170名患者。主动补充组和安慰剂组之间OSDI评分的平均变化无显著差异(分别为-13.9分和-12.5分；填补缺失数据后的平均变化差异为-1.9分；95%可信区间[CI]，-5.0~1.1；P=0.21)。这一结果在预先指定的亚组中是一致的。主动补充组和安慰剂组在结膜染色评分(平均差异为0.0分；95%CI，-0.2~0.1)、角膜染色评分(0.1分；95%CI，-0.2~0.4)、泪液破裂时间(0.2秒；95%CI，-0.1~0.5)和Schirmer‘s试验结果(0.0 mm；95%CI，-0.8~0.9)等方面与安慰剂组差异无统计学意义。12个月时，根据红细胞中n-3脂肪酸的水平，活性补充组的依从率为85.2%。两个试验组的不良事件发生率相似。结论在干眼病患者中，那些被随机分配接受3000毫克n-3脂肪酸补充剂12个月的患者并没有明显好于那些被分配接受安慰剂的患者。
BACKGROUNDDry eye disease is a common chronic condition that is characterized by ocular discomfort and visual disturbances that decrease quality of life. Many clinicians recommend the use of supplements of n-3 fatty acids (often called omega-3 fatty acids) to relieve symptoms.METHODSIn a multicenter, double-blind clinical trial, we randomly assigned patients with moderateto-severe dry eye disease to receive a daily oral dose of 3000 mg of fish-derived n-3 eicosapentaenoic and docosahexaenoic acids (active supplement group) or an olive oil placebo (placebo group). The primary outcome was the mean change from baseline in the score on the Ocular Surface Disease Index (OSDI; scores range from 0 to 100, with higher scores indicating greater symptom severity), which was based on the mean of scores obtained at 6 and 12 months. Secondary outcomes included mean changes per eye in the conjunctival staining score (ranging from 0 to 6) and the corneal staining score (ranging from 0 to 15), with higher scores indicating more severe damage to the ocular surface, as well as mean changes in the tear break-up time (seconds between a blink and gaps in the tear film) and the result on Schirmer's test (length of wetting of paper strips placed on the lower eyelid), with lower values indicating more severe signs.RESULTSA total of 349 patients were assigned to the active supplement group and 186 to the placebo group; the primary analysis included 329 and 170 patients, respectively. The mean change in the OSDI score was not significantly different between the active supplement group and the placebo group (-13.9 points and - 12.5 points, respectively; mean difference in change after imputation of missing data, - 1.9 points; 95% confidence interval [CI], -5.0 to 1.1; P = 0.21). This result was consistent across prespecified subgroups. There were no significant differences between the active supplement group and the placebo group in mean changes from baseline in the conjunctival staining score (mean difference in change, 0.0 points; 95% CI, - 0.2 to 0.1), corneal staining score (0.1 point; 95% CI, - 0.2 to 0.4), tear break-up time (0.2 seconds; 95% CI, - 0.1 to 0.5), and result on Schirmer's test (0.0 mm; 95% CI, - 0.8 to 0.9). At 12 months, the rate of adherence to treatment in the active supplement group was 85.2%, according to the level of n-3 fatty acids in red cells. Rates of adverse events were similar in the two trial groups.CONCLUSIONSAmong patients with dry eye disease, those who were randomly assigned to receive supplements containing 3000 mg of n-3 fatty acids for 12 months did not have significantly better outcomes than those who were assigned to receive placebo.