Griffiths A, Koletzko S, Sylvester F, Marcon M, Sherman P
Hospital for Sick Children, Department of Pediatrics, University of Toronto, Ontario, Canada.
J Pediatr Gastroenterol Nutr. 1993 Aug;17(2):186-92. doi: 10.1097/00005176-199308000-00010.
Pharmacologic agents effective in the treatment of Crohn's disease confined to the small intestine are limited. The therapeutic efficacy of oral mesalazine in small bowel inflammation, although theoretically promising, remains unproven. In an open-labeled initial trial, timed-release 5-aminosalicylic acid (5-ASA), administered at a daily dosage of 30.6 +/- 9.0 mg/kg (mean +/- SEM) to children with active Crohn's disease involving the small intestine, was associated with improvement on the Harvey index in six of 12 patients treated for 8.1 +/- 3.9 weeks. In a subsequent prospective, double-blind study 14 children, ages 9.3 to 16.1 years, with active Crohn's disease limited radiologically in the small intestine were randomized to receive either timed-release 5-ASA [50 mg/kg/day (maximum 3 g/day)] or placebo for 8 weeks. Following a 4-week washout period, patients crossed over to receive the other study drug for a further 8 weeks. Six children completed the entire 20-week trial. The van Hees index improved among patients receiving 5-ASA for 8 weeks (delta = -18 +/- 6.4) but deteriorated among patients given placebo (delta = +14 +/- 4.1) (p < 0.05). Mean Crohn's Disease Activity Index (CDAI) decreased marginally after 8 weeks of 5-ASA treatment (delta = -48 +/- 38.2) but not with placebo (delta = -3.0 +/- 7.9) (p = 0.31). Of the eight noncompleters, more patients dropped out of the study because of lack of therapeutic response to placebo (n = 5) than to 5-ASA (n = 2).(ABSTRACT TRUNCATED AT 250 WORDS)
对局限于小肠的克罗恩病有效的药物制剂有限。口服美沙拉嗪对小肠炎症的治疗效果，尽管理论上有前景，但仍未得到证实。在一项开放标签的初始试验中，对患有累及小肠的活动性克罗恩病的儿童，按每日剂量30.6±9.0mg/kg（均值±标准误）给予缓释5-氨基水杨酸（5-ASA），在接受治疗8.1±3.9周的12例患者中，有6例哈维指数有所改善。在随后一项前瞻性、双盲研究中，14例年龄在9.3至16.1岁、小肠放射性检查显示为活动性克罗恩病局限型的儿童，被随机分为接受缓释5-ASA[50mg/kg/天（最大3g/天）]或安慰剂治疗8周。经过4周的洗脱期后，患者交叉接受另一种研究药物再治疗8周。6例儿童完成了整个20周的试验。接受5-ASA治疗8周的患者范赫斯指数有所改善（差值=-18±6.4），而接受安慰剂治疗的患者该指数恶化（差值=+14±4.1）（p<0.05）。5-ASA治疗8周后克罗恩病活动指数（CDAI）均值略有下降（差值=-48±38.2），而安慰剂组无下降（差值=-3.0±7.9）（p=0.31）。在8例未完成试验的患者中，因对安慰剂缺乏治疗反应而退出研究的患者（n=5）多于对5-ASA缺乏反应的患者（n=2）。（摘要截短于250字）
