Biddle W L, Greenberger N J, Swan J T, McPhee M S, Miner P B
Division of Gastroenterology, University of Kansas Medical Center, Kansas City.
Gastroenterology. 1988 Apr;94(4):1075-9. doi: 10.1016/0016-5085(88)90569-0.
The efficacy of 5-aminosalicylic acid enemas in maintaining remission in left-sided ulcerative colitis was studied. Twenty-five patients in remission for at least 2 mo were randomized to receive either 1-g 5-aminosalicylic acid or placebo enemas daily and were followed up for 1 yr. Eleven of 13 patients randomized to placebo relapsed after a mean of 16 wk. Nine of 12 patients randomized to 5-aminosalicylic acid remained in remission for 1 yr, 2 others in remission withdrew by request, and 1 relapsed at 10 wk. The difference between relapse rate on 1-g 5-aminosalicylic acid versus placebo was significant (p less than 0.005). Seven patients entered the blinded trial a second time. Three of 4 patients randomized to 5-aminosalicylic acid remained in remission and 1 relapsed. Three randomized to placebo relapsed at a mean of 14 wk. One-gram 5-aminosalicylic acid enemas are safe and effective in maintaining remission in patients with left-sided ulcerative colitis.
研究了5-氨基水杨酸灌肠剂在维持左侧溃疡性结肠炎缓解中的疗效。25例缓解至少2个月的患者被随机分为两组，分别每日接受1克5-氨基水杨酸灌肠剂或安慰剂灌肠剂，并随访1年。随机接受安慰剂的13例患者中，平均16周后有11例复发。随机接受5-氨基水杨酸的12例患者中，9例维持缓解1年，另外2例应要求退出缓解期，1例在10周时复发。1克5-氨基水杨酸组与安慰剂组的复发率差异有统计学意义（p<0.005）。7例患者再次进入盲法试验。随机接受5-氨基水杨酸的4例患者中，3例维持缓解，1例复发。随机接受安慰剂的3例患者平均在14周时复发。1克5-氨基水杨酸灌肠剂在维持左侧溃疡性结肠炎患者缓解方面安全有效。
