Akobeng Anthony K, Stokkers Pieter C
Department of Paediatric Gastroenterology, Central Manchester and Manchester Children's University Hospitals, Booth Hall Children's Hospital, Charlestown Road, Blackley, Manchester, UK, M9 7AA.
Cochrane Database Syst Rev. 2009 Apr 15;2009(2):CD007351. doi: 10.1002/14651858.CD007351.pub2.
Maintenance of remission is a major issue in the management of Crohn's disease. Thalidomide, a tumour necrosis factor-alpha (TNF-alpha) inhibitor and its analogue, lenalidomide, may have a role in the management of Crohn's disease, but it is not clear whether it is an effective maintenance therapy.
To conduct a systematic review to evaluate the efficacy and safety of thalidomide and lenalidomide for the maintenance of remission in Crohn's disease.
MEDLINE (1966 to September 2008), EMBASE (1984 to September 2008), the Cochrane Central Register of Controlled Trials from the Cochrane Library (Issue 3, 2008) and the IBD/FBD Review Group Specialized Trials Register were searched to identify relevant studies.
Randomised controlled trials which compared thalidomide with either placebo or an active comparator were considered for inclusion.
No trials met the inclusion criteria.
No studies that satisfied the inclusion criteria were found. In the absence of any suitable randomised controlled trial in this area, no analysis was performed.
AUTHORS' CONCLUSIONS: There is no evidence to support or refute the use of thalidomide or its analogue, lenalidomide, as maintenance therapy for patients with Crohn's disease. Given the teratogenic nature of thalidomide its use for maintenance therapy is difficult to justify. Well designed clinical trials are needed to evaluate the efficacy and safety of lenalidomide in Crohn's disease and its use is not recommended until these data are available.
维持缓解是克罗恩病管理中的一个主要问题。沙利度胺，一种肿瘤坏死因子-α（TNF-α）抑制剂及其类似物来那度胺，可能在克罗恩病的管理中发挥作用，但它是否为有效的维持治疗尚不清楚。
进行一项系统评价，以评估沙利度胺和来那度胺用于维持克罗恩病缓解的疗效和安全性。
检索了MEDLINE（1966年至2008年9月）、EMBASE（1984年至2008年9月）、Cochrane图书馆的Cochrane对照试验中央注册库（2008年第3期）以及IBD/FBD综述组专业试验注册库，以识别相关研究。
纳入比较沙利度胺与安慰剂或活性对照的随机对照试验。
无试验符合纳入标准。
未找到满足纳入标准的研究。由于该领域缺乏任何合适的随机对照试验，未进行分析。
没有证据支持或反驳将沙利度胺或其类似物来那度胺用作克罗恩病患者的维持治疗。鉴于沙利度胺的致畸性质，其用于维持治疗难以自圆其说。需要开展设计良好的临床试验来评估来那度胺在克罗恩病中的疗效和安全性，在获得这些数据之前不建议使用。
