Olmedo Martín Raúl Vicente, Amo Trillo Víctor, González Grande Rocío, Jiménez Pérez Miguel
Unidad Gestión Clínica Aparato Digestivo, Hospital Regional Universitario Málaga, España.
UGC Aparato Digestivo, Hospital Regional Universitario de Málaga.
Rev Esp Enferm Dig. 2017 Aug;109(8):559-565. doi: 10.17235/reed.2017.4899/2017.
Oral tacrolimus is an effective drug that induces clinical remission in patients with moderate to severe ulcerative colitis refractory to steroids. However, there is little data with regard to its medium to long-term efficacy and safety. The aim of this study was to assess the medium to long-term efficacy and safety of oral tacrolimus in this challenging clinical situation.
This was a retrospective observational review of the clinical charts of 34 patients with moderate to severe ulcerative colitis refractory to steroids treated with oral tacrolimus at our hospital (July 2001-July 2016). Remission was defined as a Lichtiger index score < 3 and response was defined as a score < 10 with a reduction of at least three points compared to the baseline score.
Seven patients (20.58%) required colectomy during the follow-up period (mean 65 months). Nine patients required rescue with infliximab (four patients during the first six months of follow-up and the other five after the first six months). The short to medium clinical efficacy combining both remission and clinical response was 82% at six months. Kaplan-Meier analysis showed that the percentage of patients free from colectomy and additional sequential rescue therapy was 75% at 54 months (median follow-up). The early introduction of thiopurines (< 2 months from start of tacrolimus) showed no significant improvement in prognosis (p = 0.72). Fifty-three per cent of patients experienced adverse effects, none of whom required treatment withdrawal. No severe infections were noted during the follow-up.
口服他克莫司是一种有效的药物，可使对类固醇难治的中度至重度溃疡性结肠炎患者实现临床缓解。然而，关于其中长期疗效和安全性的数据较少。本研究的目的是评估口服他克莫司在这种具有挑战性的临床情况下的中长期疗效和安全性。
这是一项对我院（2001年7月至2016年7月）34例接受口服他克莫司治疗的对类固醇难治的中度至重度溃疡性结肠炎患者临床病历的回顾性观察性研究。缓解定义为Lichtiger指数评分<3，反应定义为评分<10且与基线评分相比至少降低3分。
7例患者（20.58%）在随访期间（平均65个月）需要进行结肠切除术。9例患者需要使用英夫利昔单抗进行挽救治疗（4例在随访的前6个月，另外5例在6个月后）。在6个月时，缓解和临床反应相结合的短期至中期临床疗效为82%。Kaplan-Meier分析显示，在54个月（中位随访时间）时，未进行结肠切除术和额外序贯挽救治疗的患者百分比为75%。早期引入硫唑嘌呤（从他克莫司开始使用起<2个月）在预后方面未显示出显著改善（p = 0.72）。53%的患者出现不良反应，其中无一例需要停药。随访期间未发现严重感染。
