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美沙拉嗪泡沫灌肠剂和美沙拉嗪液体灌肠剂在活动期左侧溃疡性结肠炎的疗效对比

Mesalamine Foam Enema Versus Mesalamine Liquid Enema in Active Left-Sided Ulcerative Colitis

Cortot A, Maetz D, Degoutte E 2009/9/21 19:30:53

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Am J Gastroenterol, 2009,

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Aim:
To determine in a noninferiority study whether mesalamine foam is as effective as mesalamine liquid enema for inducing clinical remission in patients with active left-sided ulcerative colitis (UC).

Methods:
In a multicenter investigator-blind trial, 375 patients with mild-to-moderate UC were randomized to receive mesalamine foam 1g/80mL/day or mesalamine liquid enema 1g/100mL/day for 4wk (W). Inclusion criteria were: disease extension at least 5cm from anorectal junction and not above splenic flexure and Clinical Activity Index (CAI) 1–4≥4. Primary end point was clinical remission at W4 defined as a CAI 1–4≤2. Noninferiority of the foam to liquid enema was declared if the lower limit of the 97.5% unilateral confidence interval (97.5% CI) of the difference in remission rates between foam and liquid enema groups was greater than −15%.

Results:
Remission rates at W4 in foam versus liquid were 68.3% versus 73.6% in per protocol (PP) population (lower limit of 97.5% CI −15.1%) and 66.7% versus 70.5% in intention-to-treat (ITT) population (97.5% CI −13.4%). Remission rates at W2 were 48.1 % versus 50.6% in ITT (97.5% CI −12.8%) and 49.1% versus 52.1% in PP (97.5% CI −13.8%) in foam versus liquid, respectively. Both treatments were well tolerated.

Conclusions:
A 4-wk treatment of 1g mesalamine foam induced a clinical remission in 68% patients versus 73% with 1g mesalamine liquid enema. Although the noninferiority of mesalamine foam could not be strictly demonstrated at W4 in the PP analysis, it was achieved in the ITT population and at W2 in both populations. Mesalamine foam represents a therapeutic alternative to mesalamine liquid enema in patients with mild-to-moderate active proctitis and proctosigmoiditis.

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疾病资源中心

高血压	慢性阻塞性肺病
脂肪性肝病	糖尿病
卒中	肺癌
冠心病	子宫内膜异位症
结直肠癌	乳腺癌
心力衰竭	心律失常

病例分析 [栏目介绍]

甲状腺功能亢进合并黄疸

王燕燕王曙

上海交通大学附属瑞金医院内分泌科

患者，女，69岁。2009年1月无明显诱因下出现乏力，当时程度较轻，未予以重视。2009年3月患者乏力症状加重，尿色逐渐加深，大便习惯改变，颜色变淡。4月18日入我院感染科治疗，诉轻度头晕、心慌，体重减轻10kg。无肝区疼痛，无发热，无腹痛、腹泻、腹胀、里急后重，无恶性、呕吐等。入院半月前于外院就诊，查肝功能：ALT 601IU/L，AST 785IU/L，TBIL 97.7umol/L，白蛋白 41g/L，甲状腺功能：游离T3 30.6pmol/L，游离T4 51.9pmol/L，心电图示快速房颤。

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