Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan; Department of Gastroenterology and Hepatology, Tokyo Dental College, Ichikawa General Hospital, Chiba, Japan.
J Crohns Colitis. 2013 Dec;7(12):e609-14. doi: 10.1016/j.crohns.2013.04.018. Epub 2013 May 14.
Oral administration of tacrolimus is an effective remission induction therapy for steroid-refractory/dependent ulcerative colitis (UC).
This study aimed to evaluate the short- as well as medium- and long-term effectiveness of tacrolimus therapy.
The medical records of 51 patients treated with tacrolimus for UC at our hospital between July 2009 and December 2011 were reviewed retrospectively. Clinical remission and improvement were defined as a Lichtiger score of 4 or less and as a Lichtiger score of ≤10 and a reduction in the score of ≥3 compared with the baseline score, respectively. Endoscopic findings were evaluated based on the endoscopic activity index and Mayo endoscopic score.
The clinical effectiveness combining clinical remission and improvement was observed in 62.7% of the patients at 3 months. Thirty-six patients underwent colonoscopy at 3 months, and 12 (33.3%) and 10 patients (27.8%) showed Mayo endoscopic scores of 0 and 1, respectively. On Kaplan-Meier analysis, the overall percentage of event-free survivors, who did not require colectomy nor switching to other induction therapy such as infliximab, was 73.0% at 6 months, 49.9% at 1 year, and 37.8% at 2 years. Patients with a Mayo endoscopic score of 0-1 at 3 months showed significantly better medium- and long-term prognosis than those with a score of 2-3 (p<0.01). All adverse events, including infections in 2 patients, were reversible.
Tacrolimus therapy was effective for inducing clinical and endoscopic remission of steroid-refractory/dependent UC. Endoscopic improvement was associated with favorable medium- and long-term prognosis.
口服他克莫司是治疗激素抵抗/依赖溃疡性结肠炎（UC）的有效缓解诱导治疗方法。
本研究旨在评估他克莫司治疗的短期、中期和长期疗效。
回顾性分析 2009 年 7 月至 2011 年 12 月我院 51 例 UC 患者接受他克莫司治疗的病历。临床缓解和改善定义为 Lichtiger 评分≤4 分和 Lichtiger 评分≤10 分，与基线评分相比降低≥3 分。内镜表现根据内镜活动指数和 Mayo 内镜评分进行评估。
3 个月时，62.7%的患者联合临床缓解和改善的临床疗效。36 例患者在 3 个月时行结肠镜检查，12 例（33.3%）和 10 例（27.8%）患者的 Mayo 内镜评分分别为 0 和 1。Kaplan-Meier 分析显示，无需结肠切除术或转换为其他诱导治疗（如英夫利昔单抗）的无事件幸存者总比例在 6 个月时为 73.0%，1 年时为 49.9%，2 年时为 37.8%。3 个月时 Mayo 内镜评分 0-1 的患者的中期和长期预后明显优于评分 2-3 的患者（p<0.01）。所有不良事件，包括 2 例感染，均为可逆性。
他克莫司治疗激素抵抗/依赖 UC 可诱导临床和内镜缓解。内镜改善与良好的中期和长期预后相关。
