Casellas Francesc, Rodrigo Luis, Niño Pilar, Pantiga Carmen, Riestra Sabino, Malagelada Juan-Ramon
Unitat d'Atenció Crohn-Colitis from Hospital Universitari Vall d' Hebron, Spain.
Inflamm Bowel Dis. 2007 Nov;13(11):1395-400. doi: 10.1002/ibd.20205.
Infliximab induces remission and improves the health-related quality of life (HRQOL) of patients with refractory or fistulous Crohn's disease (CD). However, little information is available as to whether its effect on HRQOL is sustained over time. The objective was to measure the HRQOL of CD patients in long-term clinical remission.
Prospective, observational study was undertaken in patients with CD in infliximab-induced clinical remission (Harvey index <3) for at least 6 months, and receiving long-term infliximab and azathioprine maintenance therapy. Patients were followed for 4 years or until clinical relapse (Harvey index >3). HRQOL was assessed annually using the validated Spanish version of the disease-specific 36-item Inflammatory Bowel Disease Questionnaire (IBDQ-36) and the EuroQol-5D.
Forty-nine patients with CD in stable clinical remission were included at baseline. At 12 months, n = 42 patients remained in remission, at 24 months n = 32 patients, at 36 months n = 13, and in the last visit at 48 months 6 patients remained in clinical remission. The overall score on the IBDQ-36 remained unchanged in patients with stable, inactive CD (median overall score of 6.1 at baseline and 6.5 at 4 years). Scores on all 5 dimensions of the IBDQ-36 remained unchanged over the study period in stable patients. Patients in remission scored highly on the preference value ratings of the EuroQol-5D (scores of 1.0) and remained unchanged in patients who remained in remission.
Sustained clinical remission of CD achieved with maintenance treatment maintains HRQOL over long-term follow-up.
英夫利昔单抗可诱导难治性或瘘管性克罗恩病(CD)患者缓解并改善其健康相关生活质量(HRQOL)。然而,关于其对HRQOL的影响是否能长期持续,目前所知甚少。目的是测量长期临床缓解的CD患者的HRQOL。
对英夫利昔单抗诱导临床缓解(哈维指数<3)至少6个月且接受长期英夫利昔单抗和硫唑嘌呤维持治疗的CD患者进行前瞻性观察研究。对患者随访4年或直至临床复发(哈维指数>3)。每年使用经过验证的西班牙文版特定疾病36项炎症性肠病问卷(IBDQ-36)和欧洲五维健康量表(EuroQol-5D)评估HRQOL。
基线时纳入49例临床缓解稳定的CD患者。12个月时,42例患者仍处于缓解状态,24个月时32例,36个月时13例,在48个月的最后一次随访中有6例患者仍处于临床缓解状态。IBDQ-36的总体评分在病情稳定、无活动的CD患者中保持不变(基线时中位数总体评分为6.1,4年时为6.5)。在研究期间,IBDQ-36所有5个维度的评分在病情稳定的患者中均保持不变。缓解期患者在欧洲五维健康量表偏好值评分中得分较高(评分为1.0),且在仍处于缓解状态的患者中保持不变。
维持治疗实现的CD持续临床缓解在长期随访中维持了HRQOL。