Feagan B G, Enns R, Fedorak R N, Panaccione R, Paré P, Steinhart A H, Wild G
London Clinical Trials Research Group, London, Canada.
Can J Clin Pharmacol. 2001 Winter;8(4):188-98.
Crohn's disease is a chronic inflammatory disorder of the gastrointestinal tract. From the perspective of the patient, symptoms of the disease significantly impair quality of life and interfere with activities of daily living. Conventional medical treatment of Crohn's disease includes the use of nonspecific anti-inflammatory drugs, immunosuppressives and antibiotics. These therapies are characterized by a delayed onset of action, incomplete response rates and a substantial risk of adverse effects. Although surgery is frequently used to treat complications, postoperative recurrence is an important problem. Infliximab, a chimeric monoclonal antibody directed toward tumour necrosis factor alpha, is highly effective for the treatment of active Crohn's disease. In randomized, placebo-controlled clinical trials, 82% of patients who received 5 mg/kg of infliximab had a clinically significant response, compared with 17% of those given placebo (P<0.001). Moreover, infliximab is the only medical therapy that has been shown to be effective for the treatment of fistulizing Crohn's disease. Infusion reactions are the most common adverse effect. Whether treatment with infliximab is associated with an increased risk of neoplasia, infection or autoimmune disease is unknown. Therefore, further long term safety studies are required. Despite the relatively high cost of drug acquisition, preliminary pharmacoeconomic analysis indicates that infliximab is cost effective compared with existing treatments. Infliximab is recommended for the treatment of active Crohn's disease refractory to conventional drugs, and is the treatment of choice for fistulizing Crohn's disease.
克罗恩病是一种胃肠道的慢性炎症性疾病。从患者的角度来看，该疾病的症状会显著损害生活质量并干扰日常生活活动。克罗恩病的传统医学治疗包括使用非特异性抗炎药、免疫抑制剂和抗生素。这些疗法的特点是起效延迟、缓解率不完全且存在相当大的不良反应风险。尽管手术经常用于治疗并发症，但术后复发是一个重要问题。英夫利昔单抗是一种针对肿瘤坏死因子α的嵌合单克隆抗体，对活动性克罗恩病的治疗非常有效。在随机、安慰剂对照的临床试验中，接受5mg/kg英夫利昔单抗治疗的患者中有82%出现了具有临床意义的缓解，而接受安慰剂治疗的患者中这一比例为17%（P<0.001）。此外，英夫利昔单抗是唯一已被证明对瘘管性克罗恩病有效的药物治疗方法。输注反应是最常见的不良反应。英夫利昔单抗治疗是否会增加肿瘤形成、感染或自身免疫性疾病的风险尚不清楚。因此，需要进一步进行长期安全性研究。尽管药物获取成本相对较高，但初步的药物经济学分析表明，与现有治疗方法相比，英夫利昔单抗具有成本效益。英夫利昔单抗被推荐用于治疗对传统药物难治的活动性克罗恩病，并且是瘘管性克罗恩病的首选治疗方法。
