Siegel Corey A, Hur Chin, Korzenik Joshua R, Gazelle G Scott, Sands Bruce E
Section of Gastroenterology and Hepatology, Inflammatory Bowel Disease Center, Dartmouth-Hitchcock Medical Center, Dartmouth Medical School, Lebanon, New Hampshire, USA.
Clin Gastroenterol Hepatol. 2006 Aug;4(8):1017-24; quiz 976. doi: 10.1016/j.cgh.2006.05.020. Epub 2006 Jul 14.
BACKGROUND & AIMS: Infliximab is effective for the treatment of active Crohn's disease. However, rare but serious complications related to infliximab therapy including lymphoma, sepsis, and death have been reported. The purpose of this study was to analyze the risks and benefits of infliximab for the treatment of Crohn's disease with the goal of providing data to aid both physicians and patients in the process of making a decision about treatment.
A decision analytic model was constructed to determine the risks and benefits of infliximab when compared with standard therapy. The analysis simulated 2 cohorts of 100,000 patients each, with one arm receiving infliximab while the other remained on standard therapy.
Model results showed that in 100,000 patients at 1 year, infliximab will lead to 12,216 more patients in remission, 4255 fewer surgeries, and 33 fewer deaths from flares of disease. This is at the cost of 201 more lymphomas and 249 more deaths related to complications from infliximab. Overall, the infliximab strategy resulted in more quality-adjusted life years (QALYs/patient) than the standard therapy strategy (.77 QALYs/patient vs .75 QALYs/patient).
Despite an increased risk of lymphoma and death associated with use of infliximab, the substantial clinical improvement and fewer surgeries as a result of infliximab result in an increase in QALYs. In properly selected patients, the benefits of infliximab could outweigh its risks. These data should help guide decision making and the informed consent process when considering the use of infliximab for the treatment of Crohn's disease.
英夫利昔单抗对活动性克罗恩病的治疗有效。然而，已有报道称与英夫利昔单抗治疗相关的罕见但严重的并发症，包括淋巴瘤、败血症和死亡。本研究的目的是分析英夫利昔单抗治疗克罗恩病的风险和益处，以便为医生和患者在治疗决策过程中提供数据支持。
构建一个决策分析模型，以确定英夫利昔单抗与标准疗法相比的风险和益处。该分析模拟了两组各100,000名患者，一组接受英夫利昔单抗治疗，另一组继续接受标准疗法。
模型结果显示，在100,000名患者中，1年后英夫利昔单抗将使缓解的患者增加12,216例，手术减少4255例，疾病发作导致的死亡减少33例。代价是淋巴瘤增加201例，与英夫利昔单抗并发症相关的死亡增加249例。总体而言，英夫利昔单抗治疗策略比标准疗法策略产生了更多的质量调整生命年（每患者QALYs）（每患者0.77 QALYs对每患者0.75 QALYs）。
尽管使用英夫利昔单抗会增加淋巴瘤和死亡风险，但英夫利昔单抗带来的显著临床改善和较少的手术导致了质量调整生命年的增加。在适当选择的患者中，英夫利昔单抗的益处可能超过其风险。这些数据应有助于在考虑使用英夫利昔单抗治疗克罗恩病时指导决策和知情同意过程。
