Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong SAR, China.
State Key Laboratory of Digestive Disease, LKS Institute of Health Science, Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong SAR, China.
J Gastroenterol Hepatol. 2022 Jul;37(7):1284-1289. doi: 10.1111/jgh.15838. Epub 2022 Apr 6.
Whether 5-aminosalicylic acid (ASA) can be stopped in patients with stable ulcerative colitis (UC) remains unclear. We aimed to examine whether 5-ASA can be safely withdrawn in UC patients who have been in corticosteroid-free clinical remission for ≥ 1 year.
This is a retrospective cohort study using territory-wide healthcare database in Hong Kong. Primary outcome was development of UC flare, defined as new corticosteroid use or UC-related hospitalizations within 5 years. UC patients on oral 5-ASA ≥ 2 g daily for ≥ 1 year with C-reactive protein (CRP) < 10 mg/dL and no 5-ASA dosage escalation, UC-related hospitalization or corticosteroid use in the past year were included. Patients on biological agents were excluded. Patients were classified as "stopping" if 5-ASA was withdrawn for ≥ 90 days within follow-up period. We performed multivariable Cox regression models adjusting for demographics, blood parameters and immunosuppressants used. Adjusted hazard ratio (aHR) with 95% confidence interval (CI) was reported comparing stopping and continuous-use groups.
A total of 1408 patients were included with a median follow-up duration of 41.8 months (interquartile range [IQR]: 17.2-60.0 months). Stopping 5-ASA was not associated with an increased risk of UC flare (aHR 0.91; 95% CI 0.64-1.31; P = 0.620). A higher CRP levels at the time of stopping 5-ASA (aHR 1.15; 95% CI: 1.01-1.30; P = 0.037) were associated with increased risk of flare.
Stopping 5-ASA in UC patients in corticosteroid-free remission for ≥ 1 year was not associated with increased risk of flare. Future prospective trials should evaluate the role of stopping 5-ASA in stable UC patients.
对于处于稳定期溃疡性结肠炎（UC）的患者，5-氨基水杨酸（5-ASA）是否可以停药仍不明确。本研究旨在探讨对于已达到无皮质激素临床缓解（缓解时间≥1 年）的 UC 患者，5-ASA 是否可以安全停药。
这是一项使用香港全港医疗数据库进行的回顾性队列研究。主要终点为 UC 复发，定义为在 5 年内新应用皮质激素或因 UC 住院。纳入标准为：口服 5-ASA 剂量≥2g/d 且持续≥1 年，C 反应蛋白（CRP）＜10mg/dL，且过去 1 年中无 5-ASA 剂量增加、因 UC 住院或使用皮质激素。排除使用生物制剂的患者。如果在随访期间停止使用 5-ASA≥90 天，则定义为“停药”。我们采用多变量 Cox 回归模型，调整了人口统计学、血液参数和免疫抑制剂的使用情况。比较停药组和持续用药组，报告调整后的风险比（aHR）及其 95%置信区间（CI）。
共纳入 1408 例患者，中位随访时间为 41.8 个月（IQR：17.2-60.0 个月）。与持续用药组相比，停药组 UC 复发的风险无显著增加（aHR 0.91；95%CI 0.64-1.31；P=0.620）。停药时 CRP 水平较高（aHR 1.15；95%CI：1.01-1.30；P=0.037）与复发风险增加相关。
对于缓解时间≥1 年且无皮质激素治疗的 UC 患者，停止 5-ASA 治疗与复发风险增加无关。未来的前瞻性试验应评估在稳定的 UC 患者中停止使用 5-ASA 的作用。
