A' Gastroenterology Clinic, Evangelismos General Hospital, 45-47 Ipsilantou street, 10675 Kolonaki, Athens, Greece.
J Crohns Colitis. 2007 Sep;1(1):28-34. doi: 10.1016/j.crohns.2007.06.002.
The long-term effectiveness of azathioprine, in Crohn's disease (CD) patients remains a matter of debate. This study aims at assessing the effectiveness and safety of azathioprine in patients treated continuously for less or more than 4 years.
Patients with steroid-dependent Crohn's disease in remission on azathioprine (2-2.5 mg/kg) for between 2 and 8 years were assigned into two groups. Patients in Group A were being treated continuously for 2 to 4 years whereas patients in Group B for 4 to 8 years. Patients were followed every month for 1 year with physical examination and laboratory tests. Compliance with treatment was also assessed every month. Every 3 months the Crohn's Disease Activity Index (CDAI) was calculated and the quality of life (QOL) Inflammatory Bowel Disease Questionnaire (IBDQ) was completed. Colonoscopy with calculation of the Crohn's Disease Endoscopic Index of Severity (CDEIS) was performed at baseline and at the end of the study. The primary end point was relapse after 1 year. Secondary end points were safety of treatment, QOL, and endoscopic healing.
Fifty-eight patients were included in Group A and 42 in Group B. The relapse rates per protocol were 19.6% and 11.9%, respectively (p: not significant). There were no significant differences overall and at each time point of the study between the two treatment groups regarding compliance with and safety of treatment, CDAI, IBDQ, and CDEIS scores. Multifactorial analysis did not identify any factor influencing the remission of disease in any patient group.
Long-term treatment with azathioprine of steroid-dependent Crohn's disease is efficacious and safe.
硫唑嘌呤在克罗恩病（CD）患者中的长期疗效仍存在争议。本研究旨在评估硫唑嘌呤治疗 2-8 年、持续治疗时间少于或多于 4 年的患者的有效性和安全性。
将处于缓解期、接受硫唑嘌呤（2-2.5mg/kg）治疗 2-8 年、且依赖激素的 CD 患者分为两组。A 组患者持续治疗 2-4 年，B 组患者持续治疗 4-8 年。所有患者每月接受一次随访，包括体格检查和实验室检查。同时，每月评估一次患者的治疗依从性。每 3 个月计算一次克罗恩病活动指数（CDAI），完成炎症性肠病问卷（IBDQ）以评估生活质量。基线和研究结束时进行结肠镜检查，并计算克罗恩病内镜严重程度指数（CDEIS）。主要终点为治疗 1 年后的复发。次要终点为治疗安全性、生活质量和内镜下愈合情况。
A 组 58 例患者，B 组 42 例患者。根据方案，两组的复发率分别为 19.6%和 11.9%（p：无统计学意义）。在整个研究期间以及研究的每个时间点，两组之间在治疗的依从性和安全性、CDAI、IBDQ 和 CDEIS 评分方面均无显著差异。多因素分析未发现任何影响疾病缓解的因素。
硫唑嘌呤长期治疗依赖激素的 CD 是有效且安全的。
