Loftus E V, Kane S V, Bjorkman D
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN 55905, USA.
Aliment Pharmacol Ther. 2004 Jan 15;19(2):179-89. doi: 10.1111/j.0269-2813.2004.01827.x.
To determine whether there is a difference in short-term adverse events in patients with ulcerative colitis treated with mesalazine, olsalazine or balsalazide.
MEDLINE was searched for articles published until 2002. Randomized trials of oral mesalazine, olsalazine or balsalazide for the treatment of active disease or the maintenance of remission were included. Outcomes of interest were the frequencies of patients experiencing adverse events and those withdrawn due to adverse events.
Forty-six trials were included. One study of mesalazine vs. sulfasalazine for active colitis showed significantly fewer patients with adverse events with mesalazine. Both balsalazide vs. sulfasalazine studies for active disease showed significantly fewer withdrawals with balsalazide. One trial of balsalazide vs. sulfasalazine for maintenance showed significantly fewer patients with adverse events with balsalazide. Otherwise, no significant differences in safety outcomes were noted.
All three 5-aminosalicylic acid agents are safe in the short term. In mesalazine-treated patients, the frequencies of adverse events or withdrawals due to adverse events were comparable with those in placebo-treated patients and lower than those in sulfasalazine-treated patients. Overall, adverse events or withdrawals were not significantly more frequent with olsalazine than with placebo or sulfasalazine. Adverse events and study withdrawals on balsalazide were less frequent than those on sulfasalazine.
确定接受美沙拉嗪、奥沙拉嗪或巴柳氮治疗的溃疡性结肠炎患者短期不良事件是否存在差异。
检索MEDLINE中截至2002年发表的文章。纳入口服美沙拉嗪、奥沙拉嗪或巴柳氮治疗活动性疾病或维持缓解的随机试验。感兴趣的结局是发生不良事件的患者频率以及因不良事件而退出研究的患者频率。
共纳入46项试验。一项美沙拉嗪与柳氮磺吡啶治疗活动性结肠炎的研究表明，美沙拉嗪组发生不良事件的患者明显较少。两项巴柳氮与柳氮磺吡啶治疗活动性疾病的研究均表明，巴柳氮组的退出研究人数明显较少。一项巴柳氮与柳氮磺吡啶维持治疗的试验表明，巴柳氮组发生不良事件的患者明显较少。除此之外，未发现安全性结局有显著差异。
所有三种5-氨基水杨酸制剂在短期内都是安全的。在接受美沙拉嗪治疗的患者中，不良事件或因不良事件而退出研究的频率与接受安慰剂治疗的患者相当，且低于接受柳氮磺吡啶治疗的患者。总体而言，奥沙拉嗪导致的不良事件或退出研究情况并不比安慰剂或柳氮磺吡啶更频繁。巴柳氮导致的不良事件和研究退出情况比柳氮磺吡啶更少。
