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首页> 外文OA文献 >Coated mesalazine (5-aminosalicylic acid) versus sulphasalazine in the treatment of active ulcerative colitis: a randomised trial.
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Coated mesalazine (5-aminosalicylic acid) versus sulphasalazine in the treatment of active ulcerative colitis: a randomised trial.

机译：美沙拉嗪（5-氨基水杨酸）与柳氮磺胺吡啶治疗活性溃疡性结肠炎的治疗：一项随机试验。

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OBJECTIVE--To assess the safety and efficacy of a preparation of mesalazine (5-aminosalicylic acid) coated with a pH dependent resin (Eudragit L) as compared with sulphasalazine in patients with active mild to moderate ulcerative colitis. DESIGN--Eight week randomised double blind parallel group study. SETTING--Forty six gastroenterology outpatient clinics in seven countries. PATIENTS--Two hundred and twenty patients aged 18-70 who met the following criteria: clinical activity index greater than or equal to 6 and endoscopic index greater than or equal to 4; no concomitant treatment for ulcerative colitis; no hypersensitivity to salicylates or sulphonamides. Of the 164 patients eligible for efficacy analysis, 87 received the coated preparation of mesalazine and 77 sulphasalazine. Most of the remaining patients (28 in each group) were ineligible for the efficacy analysis because of treatment with steroid enemas. All pretrial characteristics were comparable in the two treatment groups. INTERVENTIONS--Coated mesalazine (Mesasal) 1.5 g daily or sulphasalazine 3.0 g daily for eight weeks. Compliance monitored by pill counts. END POINT--Clinical and endoscopic remission. MEASUREMENTS AND MAIN RESULTS--Clinical activity measured by daily diary cards, assessment by investigators, and laboratory findings. Endoscopic evaluation at week 8. After four weeks 50 of 70 patients (71%) taking coated mesalazine and 38 of 58 (66%) taking sulphasalazine had achieved remission of their disease by eight weeks remission rates were 74% (37/50 patients) and 81% (35/43) in the two treatment groups respectively. Endoscopic remission at eight weeks was recorded in 20 of 41 patients (49%) taking coated mesalazine and 18 of 38 (47%) taking sulphasalazine. There was a higher incidence of adverse events among patients taking sulphasalazine (25/105; 24%) than among those taking coated mesalazine (16/115; 14%). CONCLUSION--Mesalazine coated with Eudragit L is a safe, logical alternative to sulphasalazine.
机译：目的-评估涂有pH依赖性树脂（Eudragit L）的美沙拉嗪（5-氨基水杨酸）制剂与柳氮磺胺吡啶治疗活动性轻度至中度溃疡性结肠炎的安全性和有效性。设计-八周随机双盲平行小组研究。地点-在七个国家/地区的46个胃肠病门诊诊所。患者-满足以下标准的220例年龄在18-70岁的患者：临床活动指数大于或等于6，内窥镜指数大于或等于4；没有溃疡性结肠炎的伴随治疗；对水杨酸酯或磺酰胺无超敏反应。在164位有资格进行疗效分析的患者中，有87位接受了美沙拉嗪和77份柳氮磺吡啶的包衣制剂。其余大多数患者（每组28名）由于接受类固醇灌肠治疗而没有资格进行疗效分析。在两个治疗组中，所有的审前特征均相当。干预措施-每天1.5 g的美沙拉嗪（Mesasal）涂层或每天3.0 g的柳氮磺胺吡啶为期8周。通过药丸计数监控依从性。终点-临床和内镜缓解。测量和主要结果-通过日常日记卡测量的临床活动，研究者的评估和实验室检查结果。在第8周进行内窥镜评估。四周后，服用涂膜美沙拉嗪的70例患者中有50例（71％），服用柳氮磺胺吡啶的58例中38例（66％）已实现疾病缓解，八周后缓解率为74％（37/50例）和两个治疗组中分别为81％（35/43）。记录有41例服用美沙拉嗪的患者中有20例（49％）在8周内镜下缓解，而服用柳氮磺吡啶的38例中有18例（47％）有内镜缓解。服用柳氮磺胺吡啶的患者（25/105； 24％）的不良事件发生率高于服用包膜美沙拉嗪的患者（16/115； 14％）。结论-涂有Eudragit L的美沙拉嗪是一种安全，合乎逻辑的替代柳氮磺胺吡啶的替代品。

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    Rachmilewitz, D.;

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  • 年度 1989
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