Kin Cindy, Kate Bundorf M
Department of Surgery, Stanford University School of Medicine, 300 Pasteur Drive, H3680, Stanford, CA, 94305, USA.
Department of Health Research & Policy, Stanford University School of Medicine, Stanford, CA, USA.
J Gastrointest Surg. 2017 Jul;21(7):1159-1165. doi: 10.1007/s11605-017-3431-0. Epub 2017 May 8.
Infliximab was approved for ulcerative colitis in 2005 after randomized trials showed it reduced the risk of colectomy. Its effect on population-level surgery rates is unknown. Our aim is to assess the impact of infliximab approval for ulcerative colitis on surgical intervention.
Retrospective review of a private insurance claims database (2002 to 2013) was performed of patients aged 18-64 diagnosed with ulcerative colitis and with 2 years of follow-up. Outcome measures were infliximab treatment and surgical resection. Multivariable logistic regression used independent variables of time period of diagnosis, age, gender, comorbidities, and insurance type.
The cohort included 58,681 patients. Age, gender, and comorbidities were comparable across time periods. Patients diagnosed in the post-infliximab period had greater odds of undergoing infliximab treatment within the first year of diagnosis than those in the pre-infliximab era (OR = 2.88, p < 0.001). However, the odds of undergoing total colectomy or total proctocolectomy were also higher in patients diagnosed in the post-infliximab period (OR 1.5, p < 0.001).
The use of infliximab for ulcerative colitis has, as expected, increased since its approval, but so has the risk of surgery. Thus, the introduction of biologic therapy has not decreased the risk for surgery for this patient population.
2005年，英夫利昔单抗被批准用于治疗溃疡性结肠炎，此前的随机试验表明其降低了结肠切除术的风险。其对总体手术率的影响尚不清楚。我们的目的是评估英夫利昔单抗获批用于溃疡性结肠炎对手术干预的影响。
对一个私人保险理赔数据库（2002年至2013年）进行回顾性研究，纳入年龄在18 - 64岁、被诊断为溃疡性结肠炎且有2年随访期的患者。观察指标为英夫利昔单抗治疗和手术切除。多变量逻辑回归使用诊断时间段、年龄、性别、合并症和保险类型作为自变量。
该队列包括58,681名患者。不同时间段的年龄、性别和合并症具有可比性。在英夫利昔单抗获批后诊断的患者在诊断后第一年内接受英夫利昔单抗治疗的几率高于英夫利昔单抗获批前的患者（比值比 = 2.88，p < 0.001）。然而，在英夫利昔单抗获批后诊断的患者接受全结肠切除术或全直肠结肠切除术的几率也更高（比值比1.5，p < 0.001）。
正如预期的那样，自获批以来，英夫利昔单抗在溃疡性结肠炎中的使用有所增加，但手术风险也增加了。因此，生物疗法的引入并未降低该患者群体的手术风险。
