Belluzzi A, Brignola C, Campieri M, Pera A, Boschi S, Miglioli M
Institute of Clinical Medicine and Gastroenterology, University of Bologna, Italy.
N Engl J Med. 1996 Jun 13;334(24):1557-60. doi: 10.1056/NEJM199606133342401.
Patients with Crohn's disease may have periods of remission, interrupted by relapses. Because fish oil has antiinflammatory actions, it could reduce the frequency of relapses, but it is often poorly tolerated because of its unpleasant taste and gastrointestinal side effects.
We performed a one-year, double-blind, placebo-controlled study to investigate the effects of a new fish-oil preparation in the maintenance of remission in 78 patients with Crohn's disease who had a high risk of relapse. The patients received either nine fish-oil capsules containing a total of 2.7 g of n-3 fatty acids or nine placebo capsules daily. A special coating protected the capsules against gastric acidity for at least 30 minutes.
Among the 39 patients in the fish-oil group, 11 (28 percent) had relapses, 4 dropped out because of diarrhea, and 1 withdrew for other reasons. In contrast, among the 39 patients in the placebo group, 27 (69 percent) had relapses, 1 dropped out because of diarrhea, and 1 withdrew for other reasons (difference in relapse rate, 41 percentage points; 95 percent confidence interval, 21 to 61; P < 0.001). After one year, 23 patients (59 percent) in the fish-oil group remained in remission, as compared with 10 (26 percent) in the placebo group (P = 0.003). Logistic-regression analysis indicated that only fish oil and not sex, age, previous surgery, duration of disease, or smoking status affected the likelihood of relapse (odds ratio for the placebo group as compared with the fish-oil group, 4.2; 95 percent confidence interval, 1.6 to 10.7).
In patients with Crohn's disease in remission, a novel enteric-coated fish-oil preparation is effective in reducing the rate of relapse.
克罗恩病患者可能会有缓解期,但会被复发打断。由于鱼油具有抗炎作用,它可能会降低复发频率,但因其味道不佳和胃肠道副作用,耐受性往往较差。
我们进行了一项为期一年的双盲、安慰剂对照研究,以调查一种新的鱼油制剂对78例复发风险高的克罗恩病患者维持缓解的效果。患者每天服用9粒鱼油胶囊,共含2.7克n-3脂肪酸,或9粒安慰剂胶囊。一种特殊涂层可保护胶囊至少30分钟免受胃酸影响。
鱼油组的39例患者中,11例(28%)复发,4例因腹泻退出,1例因其他原因退出。相比之下,安慰剂组的39例患者中,27例(69%)复发,1例因腹泻退出,1例因其他原因退出(复发率差异为41个百分点;95%置信区间为21至61;P<0.001)。一年后,鱼油组23例患者(59%)仍处于缓解期,而安慰剂组为10例(26%)(P = 0.003)。逻辑回归分析表明,只有鱼油而非性别、年龄、既往手术史、病程或吸烟状况会影响复发可能性(安慰剂组与鱼油组相比的优势比为4.2;95%置信区间为1.6至10.7)。
对于处于缓解期的克罗恩病患者,一种新型肠溶包衣鱼油制剂可有效降低复发率。