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首页> 外文期刊>Expert opinion on biological therapy >Infliximab and ulcerative colitis.
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Infliximab and ulcerative colitis.

机译：英夫利昔单抗和溃疡性结肠炎。

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Tumour necrosis factor (TNF)-alpha is an inflammatory cytokine that plays a main role in the inflammatory process underlying inflammatory bowel disease (IBD). Despite the fact that the cytokine profiles associated with ulcerative colitis (UC) and Crohn's disease (CD) are classically considered different (a Th2 pattern in UC and a Th1 pattern in CD), there are several evidences in vitro and in vivo that TNF-alpha has an important role in UC. For this reason, infliximab, the chimeric monoclonal antibody to TNF-alpha, has been evaluated in the therapy of UC. The drug has been evaluated in different clinical settings both in adults and in children: in moderate-severe steroid-dependent UC, in severe refractory UC as rescue therapy, in active non-steroid-refractory UC, in resistant pouchitis and in maintenance of moderate-severe UC responsive to infliximab. On the basis of the randomised controlled trials (RCTs), it is possible to draw the following conclusions for adults: infliximab seems active in severe steroid-refractory UC, allowing colectomy to be spared even if further controlled trials are needed with a larger sample of patients adopting strict and well-defined inclusion criteria. The drug seems active in inducing remission after 8 weeks in steroid-refractory patients, in patients taking steroids (even if it is not clear at which dosage of steroid dependence the drug is more active) and also in patients failing aminosalicylates therapy. The long-term response of infliximab in comparison to placebo in these subgroups of patients is not clinically impressive even if it is statistically significant. Further trials are warranted in order to establish the role of infliximab in steroid-dependent UC (defined with clear criteria), in maintaining remission after severe UC, in non-steroid-dependent moderate-severe UC and in refractory pouchitis. For children it is not possible to draw the same conclusions, due to a lack of RCTs, despite the encouraging data coming from open studies, mainly in steroid-refractory UC.
机译：肿瘤坏死因子（TNF）-α是一种炎症细胞因子，在引起炎症性肠病（IBD）的炎症过程中起主要作用。尽管通常认为与溃疡性结肠炎（UC）和克罗恩氏病（CD）相关的细胞因子谱是不同的（UC中的Th2模式和CD中的Th1模式），但在体外和体内都有一些证据表明TNF-α alpha在UC中具有重要作用。因此，已经在UC的治疗中评估了英夫利昔单抗（一种针对TNF-α的嵌合单克隆抗体）。该药物已在成人和儿童的不同临床环境中进行了评估：中度至重度类固醇依赖性UC，重度难治性UC作为抢救治疗，活动性非类固醇难治性UC，耐药性囊炎和中度维持-对英夫利昔单抗有反应的严重UC。根据随机对照试验（RCT），可以为成年人得出以下结论：英夫利昔单抗在重度类固醇难治性UC患者中似乎很活跃，即使需要更多的更大样本的对照试验也可以避免结肠切除术采用严格和明确定义的纳入标准的患者。在类固醇难治性患者，服用类固醇的患者（即使尚不清楚该类固醇依赖的剂量更有效）方面以及在未使用氨基水杨酸酯治疗的患者中，该药物似乎在诱导8周后缓解中起作用。在这些亚组患者中，英夫利昔单抗相对于安慰剂的长期反应在临床上并不令人印象深刻，即使在统计学上也是如此。为了确定英夫利昔单抗在类固醇依赖性UC（明确标准中定义），维持严重UC后的缓解，在非类固醇依赖性中度重度UC和难治性囊炎中的作用，有必要进行进一步的试验。对于儿童，由于缺乏随机对照试验，不可能得出相同的结论，尽管开放研究的数据令人鼓舞，主要是在类固醇难治性UC患者中。

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