Sutherland L R, May G R, Shaffer E A
University of Calgary, Alberta, Canada.
Ann Intern Med. 1993 Apr 1;118(7):540-9. doi: 10.7326/0003-4819-118-7-199304010-00009.
To assess the effectiveness of the newer 5-aminosalicylic acid (5-ASA) delivery systems compared with placebo or sulfasalazine for the treatment of active ulcerative colitis and for the maintenance of remission.
Pertinent studies were selected using the MEDLINE and BIOS (1981 to 1992) data bases, reference lists from published articles, reviews, symposia proceedings, and abstracts from major gastrointestinal meetings.
Randomized controlled trials of 5-ASA compared with placebo or sulfasalazine of a minimum of 4 weeks duration for active disease and a minimum of 6 months for maintenance of disease remission. Sixteen trials of 5-ASA for active disease, published either in abstract or full manuscript, were available. Eleven trials of 5-ASA for maintenance of remission were also reviewed.
Crude rates for either induction of remission (active disease studies) or maintenance of remission (relapse-prevention trials) based on the intention-to-treat principle were extracted from the studies by two independent observers. Each study was given a quality score, based on predetermined criteria.
Studies were placed in three groups: 5-ASA compared with placebo, 5-ASA compared with sulfasalazine for active disease, and 5-ASA compared with sulfasalazine for maintenance of remission. 5-Aminosalicylic acid was superior to placebo in the treatment of active ulcerative colitis (pooled odds ratio, 2.02; 95% CI, 1.50 to 2.72). A dose-response effect for 5-ASA existed (P < 0.001). For active disease, the pooled odds ratio for 5-ASA compared with sulfasalazine was 1.15 (CI, 0.83 to 1.61). When 5-ASA was compared with sulfasalazine for maintenance of disease remission, the pooled odds ratio was 0.85 (CI, 0.64 to 1.15). Withdrawal rates and reported side effects were similar for 5-ASA compared with placebo- or sulfasalazine-treated patients.
Although the newer 5-ASA preparations in a dose of at least 2 g/d are more effective than placebo in the treatment of ulcerative colitis, insufficient evidence exists to suggest that they are superior to sulfasalazine. Although they offer a benefit to the sulfasalazine-sensitive patient, use of 5-ASA preparations instead of sulfasalazine in the treatment of ulcerative colitis cannot yet be substantiated.
评估新型5-氨基水杨酸（5-ASA）给药系统与安慰剂或柳氮磺胺吡啶相比，在治疗活动期溃疡性结肠炎及维持缓解方面的有效性。
利用MEDLINE和BIOS（1981年至1992年）数据库、已发表文章的参考文献列表、综述、研讨会论文集以及主要胃肠病学会议的摘要，筛选相关研究。
5-ASA与安慰剂或柳氮磺胺吡啶进行比较的随机对照试验，治疗活动期疾病的疗程至少4周，维持疾病缓解的疗程至少6个月。有16项关于5-ASA治疗活动期疾病的试验，以摘要或全文形式发表。还对11项关于5-ASA维持缓解的试验进行了综述。
两名独立观察者根据意向性治疗原则，从研究中提取缓解诱导率（活动期疾病研究）或缓解维持率（预防复发试验）的粗率。根据预定标准，对每项研究进行质量评分。
研究分为三组：5-ASA与安慰剂比较、5-ASA与柳氮磺胺吡啶比较用于治疗活动期疾病、5-ASA与柳氮磺胺吡啶比较用于维持缓解。5-氨基水杨酸在治疗活动期溃疡性结肠炎方面优于安慰剂（合并比值比，2.02；95%可信区间，1.50至2.72）。5-ASA存在剂量反应效应（P<0.001）。对于活动期疾病，5-ASA与柳氮磺胺吡啶比较的合并比值比为1.15（可信区间，0.83至1.61）。当5-ASA与柳氮磺胺吡啶比较维持疾病缓解时，合并比值比为0.85（可信区间，0.64至1.15）。与安慰剂或柳氮磺胺吡啶治疗的患者相比，5-ASA的撤药率和报告的副作用相似。
尽管剂量至少为2 g/d的新型5-ASA制剂在治疗溃疡性结肠炎方面比安慰剂更有效，但尚无足够证据表明它们优于柳氮磺胺吡啶。虽然它们对柳氮磺胺吡啶敏感的患者有益，但在溃疡性结肠炎治疗中用5-ASA制剂替代柳氮磺胺吡啶的用法尚未得到证实。
