Avallone E V, Pica R, Cassieri C, Zippi M, Paoluzi P, Vernia P
Department of Internal Medicine and Medical Specialties, Gastroenterology Unit, Sapienza University of Rome, Rome, Italy.
Eur Rev Med Pharmacol Sci. 2014;18(2):165-70.
Azathioprine (AZA) and 6-mercaptopurine (6-MP), purine analogues, are the immunosuppressant drugs most frequently used for inducing and maintaining remission in inflammatory bowel disease (IBD). The occurrence of adverse effects is a major drawback in the use of these drugs, and short- and long-term toxicity represent a major limitation to their use.
The present study investigated the prevalence, type and time of onset of AZA-related adverse events, in a cohort of IBD patients in a single referral Centre.
The records of consecutive IBD outpatients, referred to our Institution between 1987-2009, were retrospectively evaluated.
We reviewed 2014 patients, in whom AZA was prescribed in 302 of them, 139 (46%) with ulcerative colitis (UC) and 163 (54%) with Crohn's disease (CD). Side-effects were complained by 98 (32.4%) out of 302 patients, 50 UC and 48 CD, (36% UC vs 29.4% CD, p = 0.26). In 20 (20.4%) patients, 11 UC and 9 CD, side-effects recovered after dosage reduction whilst in 78 (79.6%), 39 UC and 39 CD, the treatment was discontinued (dose-dependent side-effects in 42 patients and dose-independent in 36). Overall, side-effects were observed after a mean period of 14.5 ± 7.8 months (range 0.5-123) of AZA treatment. The majority (76%) of the dose-dependent adverse events were reported between 12-18 months after the beginning of treatment.
The prevalence of side effects leading to withdrawal of AZA treatment, in our series of Italian patients, was higher respect to data reported in the literature (25.8%).
硫唑嘌呤（AZA）和6-巯基嘌呤（6-MP）作为嘌呤类似物，是炎症性肠病（IBD）诱导缓解和维持缓解最常用的免疫抑制药物。不良反应的发生是使用这些药物的主要缺点，短期和长期毒性是其使用的主要限制。
本研究调查了在单一转诊中心的一组IBD患者中，与AZA相关不良事件的发生率、类型和发生时间。
回顾性评估了1987年至2009年间转诊至我们机构的连续性IBD门诊患者的记录。
我们审查了2014例患者，其中302例患者使用了AZA，139例（46%）为溃疡性结肠炎（UC），163例（54%）为克罗恩病（CD）。302例患者中有98例（32.4%）抱怨有副作用，50例UC患者和48例CD患者（UC患者为36%，CD患者为29.4%，p = 0.26）。20例（20.4%）患者，11例UC患者和9例CD患者，在减量后副作用恢复，而78例（79.6%），39例UC患者和39例CD患者，治疗中断（42例患者为剂量依赖性副作用，36例为非剂量依赖性）。总体而言，在AZA治疗平均14.5±7.8个月（范围0.5 - 123个月）后观察到副作用。大多数（76%）剂量依赖性不良事件在治疗开始后12 - 18个月报告。
在我们这组意大利患者中，导致停用AZA治疗的副作用发生率高于文献报道的数据（25.8%）。
