Campieri M, De Franchis R, Bianchi Porro G, Ranzi T, Brunetti G, Barbara L
Institute of Clinical Medicine and Gastroenterology, University of Bologna, Italy.
Scand J Gastroenterol. 1990 Jul;25(7):663-8. doi: 10.3109/00365529008997590.
A multicentre double-blind study was conducted to evaluate the efficacy and tolerability of 1 g or 1.5 g mesalazine daily compared with placebo in 94 patients with mild to moderate distal proctosigmoiditis (less than 20 cm). The study end point was the determination of clinical, endoscopic, and histologic remission rates at 4 weeks. Eleven patients, nine receiving placebo and two receiving 1.5 g mesalazine, withdrew during trial, mostly because of worsening of symptoms. At 4 weeks clinical remission was achieved in 7 of 31 (39%) patients with placebo, in 22 of 32 (69%) patients in the 1 g mesalazine group, and 23 of 31 (74%) patients in the 1.5 g mesalazine group. No serious clinical or biochemical side effect of treatment was reported. Mesalazine suppositories are safe, well tolerated, and very effective in patients with active distal proctosigmoiditis: 500 mg twice daily appears a suitable dose regimen.
一项多中心双盲研究对94例轻度至中度远端直肠乙状结肠炎（累及范围小于20 cm）患者进行了评估，比较每日服用1 g或1.5 g美沙拉嗪与安慰剂的疗效和耐受性。研究终点是在4周时测定临床、内镜和组织学缓解率。11例患者在试验期间退出，其中9例接受安慰剂，2例接受1.5 g美沙拉嗪，主要原因是症状恶化。4周时，安慰剂组31例患者中有7例（39%）实现临床缓解；1 g美沙拉嗪组32例患者中有22例（69%）实现临床缓解；1.5 g美沙拉嗪组31例患者中有23例（74%）实现临床缓解。未报告治疗有严重的临床或生化副作用。美沙拉嗪栓剂对活动性远端直肠乙状结肠炎患者安全、耐受性良好且非常有效：每日两次500 mg似乎是合适的剂量方案。
