Lau Cheryl, Dubinsky Marla, Melmed Gil, Vasiliauskas Eric, Berel Dror, McGovern Dermot, Ippoliti Andrew, Shih David, Targan Stephan, Fleshner Phillip
*Division of Colorectal Surgery, Department of General Surgery †Department of Pediatrics ‡F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles, CA.
Ann Surg. 2015 Mar;261(3):487-96. doi: 10.1097/SLA.0000000000000757.
Assess the impact of preoperative serum antitumor necrosis factor-α (anti-TNFα) drug levels on 30-day postoperative morbidity in inflammatory bowel disease (IBD) patients.
Studies on the association of anti-TNFα drugs and postoperative outcomes in IBD are conflicting due to variable pharmacokinetics of anti-TNFα drugs. It remains to be seen whether preoperative serum anti-TNFα drug levels correlate with postoperative morbidity.
Thirty-day postoperative outcomes of consecutive IBD surgical patients with serum drawn within 7 days preoperatively were studied. The total serum level of 3 anti-TNFα drugs (infliximab, adalimumab, and certolizumab) was measured, with ≥ 0.98 μg/mL considered as detected. Data were also reviewed according to a clinical cutoff value of 3 μg/mL.
A total of 217 patients [123 with Crohn disease (CD) and 94 with ulcerative colitis (UC)] were analyzed; 75 of 150 (50%) treated with anti-TNFα therapy did not have detected levels at the time of surgery. In the UC cohort, adverse postoperative outcome rates between the undetectable and detectable groups were similar when stratified according to type of UC surgery. In the CD cohort, there was a higher but statistically insignificant rate of adverse outcomes in the detectable versus undetectable groups. Using a cut off level of 3 μg/mL, postoperative morbidity (odds ratio [OR] = 2.5, P = 0.03) and infectious complications (OR = 3.0, P = 0.03) were significantly higher in the ≥ 3 μg/mL group. There were higher rates of postoperative morbidity (P = 0.047) and hospital readmissions (P = 0.04) in the ≥ 8 μg/mL compared with <3 μg/mL group.
Increasing preoperative serum anti-TNFα drug levels are associated with adverse postoperative outcomes in CD but not UC patients.
评估术前血清抗肿瘤坏死因子-α(抗TNFα)药物水平对炎症性肠病(IBD)患者术后30天发病率的影响。
由于抗TNFα药物的药代动力学存在差异,关于抗TNFα药物与IBD术后结局之间关联的研究结果相互矛盾。术前血清抗TNFα药物水平是否与术后发病率相关仍有待观察。
对术前7天内采血的连续IBD手术患者的术后30天结局进行研究。检测3种抗TNFα药物(英夫利昔单抗、阿达木单抗和赛妥珠单抗)的总血清水平,≥0.98μg/mL视为检测到。还根据3μg/mL的临床临界值对数据进行了回顾。
共分析了217例患者[123例克罗恩病(CD)和94例溃疡性结肠炎(UC)];150例接受抗TNFα治疗的患者中有75例(50%)在手术时未检测到药物水平。在UC队列中,根据UC手术类型分层时,未检测到和检测到药物水平的两组之间术后不良结局发生率相似。在CD队列中,检测到药物水平的组与未检测到药物水平的组相比,不良结局发生率较高,但无统计学意义。采用3μg/mL的临界值时,≥3μg/mL组的术后发病率(优势比[OR]=2.5,P=0.03)和感染并发症(OR=3.0,P=0.03)显著更高。与<3μg/mL组相比,≥8μg/mL组的术后发病率(P=0.047)和住院再入院率(P=0.04)更高。
术前血清抗TNFα药物水平升高与CD患者而非UC患者的术后不良结局相关。