Department of Internal Medicine, College of Medicine, Ewha Womans University, Seoul, South Korea.
Division of Gastroenterology, Department of Internal Medicine, Inje University School of Medicine, Haeundae Paik Hospital, Busan, South Korea.
J Gastroenterol Hepatol. 2021 Sep;36(9):2463-2470. doi: 10.1111/jgh.15508. Epub 2021 Apr 18.
Data comparing the outcomes of cyclosporin A (CsA) and infliximab (IFX) as rescue therapy for steroid-refractory acute severe ulcerative colitis (SR-ASUC) among Asians are scarce.
In this single-center study, we retrospectively reviewed 121 patients with SR-ASUC according to the Truelove and Witts' criteria who received CsA or IFX as rescue therapy between 1995 and 2015. The cumulative rates of treatment failure and colectomy at 3 months were compared. Treatment failure was defined as colectomy, switch to other medications, acute flare-up events requiring steroid treatment, or adverse events leading to drug interruption.
Among 121 patients with SR-ASUC (male, 55.6%; median disease duration, 47.1 months; extensive colitis, 61.2%), 23 received CsA as rescue therapy. Baseline characteristics (e.g. age at diagnosis, sex, disease duration, disease extent at rescue therapy, and Mayo score at treatment initiation) were comparable between the two groups. During follow-up (median, 45 months; interquartile range 29.3-61.8), 84 patients (69.4%) experienced treatment failure, and 25 patients (20.7%) underwent colectomy. The CsA group and the IFX group did not show significant differences in the cumulative rates of treatment failure (39.1% vs 34.7%, P = 0.714) and colectomy (26.1% vs 13.3%, P = 0.198) at 3 months. Previous use of azathioprine (odds ratio [OR] = 2.309, 95% confidence interval [CI] = 1.076-4.951, P = 0.032) was associated with treatment failure at 3 months. Mayo score > 10 at the time of rescue therapy was significantly associated with colectomy at 3 months (OR = 8.444, 95% CI = 2.592-27.506, P < 0.001).
Among Korean patients with SR-ASUC, the rates of treatment failure and colectomy at 3 months were not significantly different between the CSA and the IFX treatment groups.
亚洲人群中,关于环孢素 A(CsA)和英夫利昔单抗(IFX)作为类固醇难治性急性重度溃疡性结肠炎(SR-ASUC)挽救治疗的疗效比较数据较为匮乏。
本单中心回顾性研究纳入了 1995 年至 2015 年间接受 CsA 或 IFX 挽救治疗的 121 例 SR-ASUC 患者(根据 Truelove 和 Witts 标准进行诊断)。比较两组患者 3 个月时的治疗失败率和结肠切除术率。治疗失败定义为结肠切除术、改用其他药物、需要类固醇治疗的急性发作事件或药物中断导致的不良事件。
在 121 例 SR-ASUC 患者中(男性占 55.6%;中位疾病病程 47.1 个月;广泛结肠炎占 61.2%),23 例患者接受 CsA 作为挽救治疗。两组患者的基线特征(如诊断时年龄、性别、疾病病程、挽救治疗时疾病范围和治疗开始时 Mayo 评分)相似。中位随访时间为 45 个月(四分位距 29.3-61.8),84 例患者(69.4%)发生治疗失败,25 例患者(20.7%)行结肠切除术。CsA 组和 IFX 组 3 个月时的治疗失败率(39.1% vs 34.7%,P=0.714)和结肠切除术率(26.1% vs 13.3%,P=0.198)无显著差异。3 个月时,既往使用硫唑嘌呤(OR=2.309,95%CI=1.076-4.951,P=0.032)与治疗失败相关。挽救治疗时 Mayo 评分>10 与 3 个月时的结肠切除术显著相关(OR=8.444,95%CI=2.592-27.506,P<0.001)。
在韩国的 SR-ASUC 患者中,CsA 组和 IFX 组 3 个月时的治疗失败率和结肠切除术率无显著差异。