Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Aliment Pharmacol Ther. 2018 Jun;47(12):1597-1609. doi: 10.1111/apt.14688. Epub 2018 May 3.
Mesalazine is the most commonly prescribed medication for mild to moderate ulcerative colitis. It is generally well tolerated with some reported side effects.
To summarise adverse drug events to mesalazine and recommend techniques for management. Furthermore, to determine if there is a dose-dependent relationship between high (>2.4 g/day) vs low dosing (≤2.4 g/day) and occurrence of adverse drug events.
A literature search for relevant studies from inception to 1 December 2017 of the MEDLINE database was conducted. Two reviewers screened all titles identified. Data obtained from randomised controlled trials was used to estimate incidence rates of each adverse event. Two reviewers independently assessed methodological risk of bias and performed data extraction.
3581 articles were initially considered. Of these, 3573 were screened, 622 reviewed and 91 included. Adverse events attributed to mesalazine included inflammatory reactions, pancreatitis, cardiotoxicity, hepatotoxicity, musculoskeletal complaints, respiratory symptoms, nephropathies and sexual dysfunction. There does not appear to be a dose-dependent relationship of mesalazine and occurrence of adverse events.
Patients on mesalazine should be monitored for worsening of ulcerative colitis and development of new onset organ dysfunction. High-dose mesalazine appears to have similar safety profile as low dose, and is not associated with greater risk of adverse events. Prior to placing a patient on mesalazine, baseline liver and renal function should be evaluated. Renal function should be periodically assessed, whereas other testing should be performed depending on development of symptoms.
美沙拉嗪是治疗轻中度溃疡性结肠炎最常用的药物。它通常具有良好的耐受性，有一些报道的副作用。
总结美沙拉嗪的药物不良反应，并推荐管理技术。此外，确定高剂量（>2.4 g/天）与低剂量（≤2.4 g/天）与药物不良反应发生之间是否存在剂量依赖性关系。
对 MEDLINE 数据库从建库至 2017 年 12 月 1 日的相关研究进行了文献检索。两位评审员筛选了所有确定的标题。从随机对照试验中获得的数据用于估计每种不良反应的发生率。两位评审员独立评估方法学偏倚风险并进行数据提取。
最初考虑了 3581 篇文章。其中，3573 篇进行了筛选，622 篇进行了综述，91 篇被纳入。归因于美沙拉嗪的不良反应包括炎症反应、胰腺炎、心脏毒性、肝毒性、肌肉骨骼投诉、呼吸道症状、肾脏病和性功能障碍。似乎没有美沙拉嗪剂量与不良反应发生之间的剂量依赖性关系。
应监测接受美沙拉嗪治疗的患者溃疡性结肠炎的恶化和新发生的器官功能障碍。高剂量美沙拉嗪似乎具有与低剂量相似的安全性，并且与不良反应的风险增加无关。在给患者开美沙拉嗪之前，应评估基线肝肾功能。应定期评估肾功能，而应根据症状的发展进行其他测试。
