Saibeni S, Virgilio T, D'Incà R, Spina L, Bortoli A, Paccagnella M, Peli M, Sablich R, Meucci G, Colombo E, Benedetti G, Girelli C M, Casella G, Grasso G, de Franchis R, Vecchi M
IRCCS Policlinico Hospital, Mangiagalli and Regina Elena Foundation Milan, Italy.
Dig Liver Dis. 2008 Oct;40(10):814-20. doi: 10.1016/j.dld.2008.03.016. Epub 2008 May 13.
Thiopurines are the most commonly used immunomodulatory drugs in inflammatory bowel diseases.
To evaluate the use, the therapeutic and safety profiles of thiopurines in a large sample of IBD patients.
We reviewed 3641 case histories of IBD patients. Thiopurines were prescribed in 582 patients (16.0%); the analysis was performed on the 553 (267 ulcerative colitis, 286 Crohn's disease) with exhaustive clinical data.
The main indications for treatment were steroid-dependence (328/553, 59.3%) and steroid-resistance (113/553, 20.7%). Thiopurines were started when CD were younger than UC patients (p<0.001) but earlier from diagnosis in UC than in CD patients (p=0.003). Efficacy was defined as optimal (258/553, 46.6%), partial (108/553, 19.5%), absent (85/553, 15.4%) and not assessable (102/553, 18.4%). Efficacy was independent of disease type, location/extension or duration and age at starting. Side effects were observed in 151/553 (27.3%) patients, leading to drug discontinuation in 101 (18.3%). 15 out of the 130 (11.5%) patients who took thiopurines for more than 4 years relapsed, more frequently in CD than in UC (OR=3.67 95% C.I. 0.98-13.69; p=0.053).
Thiopurines confirm their clinical usefulness and acceptable safety profile in managing complicated IBD patients. The majority of patients treated for longer than 4 years maintain response. No clinical and demographic predictive factors for efficacy and side effects were identified.
硫唑嘌呤是炎症性肠病中最常用的免疫调节药物。
评估硫唑嘌呤在大量炎症性肠病患者样本中的使用情况、治疗效果和安全性。
我们回顾了3641例炎症性肠病患者的病历。582例患者(16.0%)使用了硫唑嘌呤;对553例(267例溃疡性结肠炎,286例克罗恩病)有详尽临床数据的患者进行了分析。
治疗的主要指征是激素依赖(328/553,59.3%)和激素抵抗(113/553,20.7%)。开始使用硫唑嘌呤时,克罗恩病患者比溃疡性结肠炎患者年轻(p<0.001),但溃疡性结肠炎患者从诊断到开始用药的时间比克罗恩病患者早(p=0.003)。疗效定义为最佳(258/553,46.6%)、部分有效(108/553,19.5%)、无效(85/553,15.4%)和无法评估(102/553,18.4%)。疗效与疾病类型、部位/范围、病程以及开始用药时的年龄无关。151/553例(27.3%)患者出现了副作用,其中101例(18.3%)因此停药。130例服用硫唑嘌呤超过4年的患者中有15例(11.5%)复发,克罗恩病患者比溃疡性结肠炎患者更频繁(比值比=3.67,95%置信区间0.98-13.69;p=0.053)。
硫唑嘌呤在治疗复杂的炎症性肠病患者中证实了其临床效用和可接受的安全性。大多数治疗超过4年的患者维持了疗效。未发现疗效和副作用的临床及人口统计学预测因素。