Horton Nicholas, Kochhar Gursimran, Patel Kajal, Lopez Rocio, Shen Bo
*Department of Internal Medicine, The Cleveland Clinic Foundation, Cleveland, Ohio; †Center for Inflammatory Bowel Diseases, Department of Gastroenterology and Hepatology, The Cleveland Clinic Foundation, Cleveland, Ohio; ‡Department of Pharmacy, The Cleveland Clinic Foundation, Cleveland, Ohio; and §Department of Quantitative Health Sciences, The Cleveland Clinic Foundation, Cleveland, Ohio.
Inflamm Bowel Dis. 2017 Jul;23(7):1080-1087. doi: 10.1097/MIB.0000000000001116.
The administration of intravenous immunoglobulin (IVIG) has demonstrated promise in the treatment of medically refractory inflammatory bowel diseases (IBD). We aimed to identify factors associated with IVIG failures in the treatment of refractory IBD.
Our historical cohort included patients with refractory IBD admitted to our inpatient service with an exacerbation and treated with at least 1 dose of IVIG (0.4 g/kg). Detailed clinical variables were recorded for subjects. Examined outcomes included changes in disease-specific severity indices, the duration of surgery-free survival after IVIG, infusion reactions, subsequent IBD-related emergency department visits, hospital readmissions, and mortality.
Fifty-four subjects with refractory IBD (61% female, age 42 ± 16 yrs, 23 with Crohn's disease, 15 with ulcerative colitis, 16 with pouchitis) met the inclusion criteria. All disease severity scores were significantly improved after IVIG administration (Harvey-Bradshaw index P = 0.007, partial Mayo score P = 0.002, modified Pouchitis Disease Activity Index P = 0.008). Twenty-seven patients (50%) underwent surgery, with a mean surgery-free survival of 28.7 ± 3.7 months. In univariable analysis, patients with Clostridium difficile infection (CDI) had a 3-fold increased risk of bowel resection surgery after IVIG compared with those without (hazard ratio = 2.9, 95% confidence interval, 1.2-7.4; P = 0.023), and in subsequent multivariable analysis, CDI remained significant (hazard ratio = 3.0, 95% confidence interval, 1.2-7.6; P = 0.024). CDI was also associated with increased risk of hospital readmission (hazard ratio = 2.5, 95% confidence interval, 1.05-5.9; P = 0.038).
Our study demonstrates that IVIG is beneficial in patients with medically refractory IBD, and that concomitant CDI is a risk factor for the treatment failure of IVIG for refractory disease.
静脉注射免疫球蛋白(IVIG)已显示出在治疗药物难治性炎症性肠病(IBD)方面的前景。我们旨在确定与难治性IBD治疗中IVIG治疗失败相关的因素。
我们的历史队列包括因病情加重入住我院并接受至少1剂IVIG(0.4 g/kg)治疗的难治性IBD患者。记录受试者的详细临床变量。检查的结果包括疾病特异性严重程度指数的变化、IVIG后无手术生存时间、输液反应、随后与IBD相关的急诊科就诊、住院再入院和死亡率。
54例难治性IBD患者(61%为女性,年龄42±16岁,23例克罗恩病,15例溃疡性结肠炎,16例储袋炎)符合纳入标准。IVIG给药后所有疾病严重程度评分均显著改善(哈维-布拉德肖指数P = 0.007,部分梅奥评分P = 0.002,改良储袋炎疾病活动指数P = 0.008)。27例患者(50%)接受了手术,平均无手术生存时间为28.7±3.7个月。在单变量分析中,艰难梭菌感染(CDI)患者IVIG后肠道切除手术的风险比未感染患者增加3倍(风险比=2.9,95%置信区间,1.2 - 7.4;P = 0.023),在随后的多变量分析中,CDI仍然显著(风险比=3.0,95%置信区间,1.2 - 7.6;P = 0.024)。CDI还与住院再入院风险增加相关(风险比=2.5,95%置信区间,1.05 - 5.9;P = 0.038)。
我们的研究表明,IVIG对药物难治性IBD患者有益,而合并CDI是IVIG治疗难治性疾病失败的危险因素。