Kulaylat Audrey S, Kulaylat Afif N, Schaefer Eric W, Tinsley Andrew, Williams Emmanuelle, Koltun Walter, Hollenbeak Christopher S, Messaris Evangelos
Department of Surgery, College of Medicine, The Pennsylvania State University, Hershey.
Department of Public Health Sciences, College of Medicine, The Pennsylvania State University, Hershey.
JAMA Surg. 2017 Aug 16;152(8):e171538. doi: 10.1001/jamasurg.2017.1538.
Despite the increasing use of anti-tumor necrosis factor (TNF) therapy in ulcerative colitis, its effects on postoperative outcomes remain unclear, with many patients requiring surgical intervention despite optimal medical management.
To assess the association of preoperative use of anti-TNF agents with adverse postoperative outcomes.
DESIGN, SETTING, AND PARTICIPANTS: This analysis used insurance claims data from a large national database to identify patients 18 years or older with ulcerative colitis. These insured patients had inpatient and/or outpatient claims between January 1, 2005, and December 31, 2013, with Current Procedural Terminology codes for a subtotal colectomy or total abdominal colectomy, a total proctocolectomy with end ileostomy, or a combined total proctocolectomy and ileal pouch-anal anastomosis. Only data regarding the first or index surgical admission within the time frame were abstracted. Use of anti-TNF agents, corticosteroids, and immunomodulators within 90 days of surgery was identified using Healthcare Common Procedure Coding System codes. Inclusion in the study required the patient to have an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis code for ulcerative colitis. Exclusion occurred if the patient had a secondary ICD-9-CM diagnosis code for Crohn disease or if the patient was not continuously enrolled in an insurance plan for at least 180 days before and after the index surgery. Data were collected and analyzed from February 1, 2015, to June 2, 2016.
Outcomes included 90-day complications, emergency department visits, and readmissions. Multivariable logistic regression was used to model covariates, including anti-TNF agent use, on the occurrence of outcomes.
Of the 2476 patients identified, 1379 (55.7%) were men, and the mean (SD) age was 42.1 (12.9) years. Among these, 950 (38.4%) underwent subtotal colectomy or total abdominal colectomy, 354 (14.3%) underwent total proctocolectomy with end ileostomy, and 1172 (47.3%) received ileal pouch-anal anastomoses. In univariate analyses, increased postoperative complications were observed among patients in the ileal pouch cohort who received anti-TNF agents preoperatively vs those who did not (137 [45.2%] vs 327 [37.6%]; P = .02) but not among those in the colectomy or proctocolectomy cohorts. An increase in complications was also observed on multivariable analyses among patients in the ileal pouch cohort (odds ratio, 1.38; 95% CI, 1.05-1.82).
Unlike preoperative anti-TNF agent use among patients who underwent colectomy or total proctocolectomy and experienced no significant increase in postoperative complications, anti-TNF agent use within 90 days of surgery among patients who underwent ileal pouch-anal anastomosis was associated with higher 90-day postoperative complication rates.
尽管抗肿瘤坏死因子(TNF)疗法在溃疡性结肠炎中的应用日益增加,但其对术后结局的影响仍不明确,许多患者尽管接受了最佳的药物治疗仍需要手术干预。
评估术前使用抗TNF药物与不良术后结局之间的关联。
设计、设置和参与者:本分析使用了来自一个大型国家数据库的保险理赔数据,以识别18岁及以上的溃疡性结肠炎患者。这些参保患者在2005年1月1日至2013年12月31日期间有住院和/或门诊理赔记录,其当前操作术语代码用于次全结肠切除术、全腹结肠切除术、带末端回肠造口术的全直肠结肠切除术或全直肠结肠切除术与回肠袋肛管吻合术联合手术。仅提取了该时间范围内首次或索引手术入院的数据。使用医疗保健通用程序编码系统代码确定手术90天内抗TNF药物、皮质类固醇和免疫调节剂的使用情况。纳入本研究要求患者有国际疾病分类第九版临床修订本(ICD-9-CM)的溃疡性结肠炎诊断代码。如果患者有克罗恩病的二级ICD-9-CM诊断代码,或者患者在索引手术前后至少180天未持续参加保险计划,则排除该患者。数据于2015年2月1日至2016年6月2日收集和分析。
结局包括90天并发症、急诊就诊和再入院。使用多变量逻辑回归对包括抗TNF药物使用在内的协变量进行建模,以分析结局的发生情况。
在识别出的2476例患者中,1379例(55.7%)为男性,平均(标准差)年龄为42.1(12.9)岁。其中,950例(38.4%)接受了次全结肠切除术或全腹结肠切除术,354例(14.3%)接受了带末端回肠造口术的全直肠结肠切除术,1172例(47.3%)接受了回肠袋肛管吻合术。在单变量分析中,术前接受抗TNF药物治疗的回肠袋组患者术后并发症发生率高于未接受抗TNF药物治疗的患者(137例[45.2%]对327例[37.6%];P = 0.02),但在结肠切除术或直肠结肠切除术组中未观察到这种差异。在多变量分析中,回肠袋组患者的并发症也有所增加(比值比,1.38;95%置信区间,1.05 - 1.82)。
与接受结肠切除术或全直肠结肠切除术且术前使用抗TNF药物但术后并发症无显著增加的患者不同,接受回肠袋肛管吻合术的患者在手术90天内使用抗TNF药物与术后90天并发症发生率较高相关。