Behm Brian W, Bickston Stephen J
Stephen J. Bickston, MD University of Virginia Digestive Health Center of Excellence, 800708 UVAHS, Charlottesville, VA 22908, USA.
Curr Treat Options Gastroenterol. 2007 Jun;10(3):171-7. doi: 10.1007/s11938-007-0010-6.
Infliximab is arguably the first major advance in therapy for inflammatory bowel disease in more than a quarter of a century. Although it is important to distinguish efficacy from effectiveness, the data from clinical practice mirror those from randomized controlled trials. Infliximab has proven efficacious for luminal manifestations of Crohn's disease (CD) regardless of location. It also has proven efficacy in the subset of penetrating disease to the skin and perianal area, and it increases rates of steroid-free remission. These benefits are reflected in improved quality of life, with limited data showing that infliximab can decrease rates of hospitalization and CD-related surgery. Infliximab also has proven to be efficacious in patients with ulcerative colitis (UC) and has increased rates of steroid-free remission. Whether infliximab will have an impact on the risk of colorectal cancer in UC and Crohn's colitis has yet to be determined. The combination of strong evidence from large randomized controlled trials with substantial examination of use in the practice setting has moved biologic therapy with infliximab from novel to mainstream. In this review, the data for the efficacy of infliximab in controlled trials will be discussed in the context of real world effectiveness.
英夫利昔单抗可谓是25多年来炎症性肠病治疗领域的首个重大进展。虽然区分疗效和有效性很重要，但临床实践数据与随机对照试验数据相符。英夫利昔单抗已被证明对克罗恩病（CD）的肠腔表现有效，无论病变位于何处。它在穿透性皮肤和肛周疾病亚组中也已证明有效，并且能提高无激素缓解率。这些益处反映在生活质量的改善上，有限的数据表明英夫利昔单抗可降低住院率和与CD相关的手术率。英夫利昔单抗在溃疡性结肠炎（UC）患者中也已证明有效，并且提高了无激素缓解率。英夫利昔单抗是否会对UC和克罗恩病性结肠炎患者患结直肠癌的风险产生影响尚待确定。大型随机对照试验的有力证据与在实际应用中的大量研究相结合，使得英夫利昔单抗的生物治疗已从新型疗法转变为主流疗法。在本综述中，将在实际疗效的背景下讨论英夫利昔单抗在对照试验中的疗效数据。
