*Department of Medicine, New York Presbyterian Weill Cornell Medical College, New York, New York; †Department of Gastroenterology and Hepatology, New York Presbyterian Weill Cornell Medical College, New York, New York; ‡Weill Cornell Medical College, New York, New York; and §Department of Medicine, New York University, New York, New York.
Inflamm Bowel Dis. 2017 Oct;23(10):1882-1889. doi: 10.1097/MIB.0000000000001189.
Infliximab (IFX) is commonly used in patients with inflammatory bowel disease. One common side effect of IFX is an acute infusion reaction. Despite the lack of evidence supporting their use, clinicians use various premedications to prevent acute reactions. We evaluated the effectiveness of premedications in the prevention of acute IFX infusion reactions.
A retrospective cohort study was performed identifying patients with a diagnosis of inflammatory bowel disease who received IFX at our institution. Information about each IFX infusion was recorded, including the dose, infusion rate, use of premedications, and any reactions. Infusions were stratified into low and high risk. In the high- and low-risk groups, the relative risk was calculated for each premedication combination used in our institution.
Seven hundred seventy-three patients were identified; 578 patients (7090 infusions) met inclusion criteria and were included for analysis. Nine hundred eighty-six high-risk infusions were isolated; 620 (62.8%) of these infusions were administered with premedications (diphenhydramine and/or hydrocortisone) and 53 (5.4%) reactions occurred. Six thousand one hundred four low-risk infusions were identified; 2253 (36.9%) of these infusions had premedications and 61 (1.0%) reactions occurred. In both groups, none of the premedications used resulted in a significantly lower reaction rate compared with no premedication use.
In both the high- and low-risk cohorts in this study, premedication use was not effective in reducing the rate of acute IFX reactions. Given this, routine premedication use is not recommended without future randomized control trials to demonstrate efficacy.
英夫利昔单抗(IFX)常用于治疗炎症性肠病患者。IFX 的常见副作用之一是急性输注反应。尽管缺乏支持其使用的证据,但临床医生使用各种预处理药物来预防急性反应。我们评估了预处理药物预防 IFX 急性输注反应的效果。
进行了一项回顾性队列研究,确定了在我们机构接受 IFX 治疗的炎症性肠病患者。记录了每位 IFX 输注的信息,包括剂量、输注速度、预处理药物的使用情况以及任何反应。将输注分为低风险和高风险。在高风险和低风险组中,计算了我们机构使用的每种预处理药物组合的相对风险。
共确定了 773 名患者;578 名患者(7090 次输注)符合纳入标准并纳入分析。分离出 986 次高风险输注;其中 620 次(62.8%)输注时使用了预处理药物(苯海拉明和/或氢化可的松),发生了 53 次(5.4%)反应。确定了 6104 次低风险输注;其中 2253 次(36.9%)输注时使用了预处理药物,发生了 61 次(1.0%)反应。在这两个组中,与未使用预处理药物相比,使用任何预处理药物都没有显著降低反应率。
在本研究的高风险和低风险队列中,预处理药物的使用并不能有效降低 IFX 急性反应的发生率。因此,在没有未来的随机对照试验证明其疗效的情况下,不建议常规使用预处理药物。