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目的了解硫唑嘌呤(AZA)治疗炎症性肠病不良反应的类型、发生率、发生时间及转归。方法 回顾性分析1995年3月～2009年9月北京协和医院接受硫唑嘌呤治疗的85例炎症性肠病患者的病历资料,其中溃疡性结肠炎37例,克罗恩病48例。结果 37例(43.5%)患者出现不良反应共43次,其中48%(20/43)的不良反应发生在用药1个月内。常见不良反应为:血液系统损害16例,感染10例,胃肠道反应9例,肝功能损害5例,其他不良反应有头晕或头痛、乏力、关节痛、皮疹。15%患者(11/85)因不良反应停药,其中白细胞减少3例,感染、胃肠道反应、头晕或头痛各2例,关节痛、皮疹各1例;55%(6/11)停药发生在用药1月内。Logistic回归分析显示:女性患者白细胞减少发生率是男性患者的5.98倍,增加AZA剂量≥75mg/d的患者白细胞降低的总发生率是未增加者的4.89倍。患者年龄、性别、用药剂量、联用SASP、联用激素及用药时间相对感染的发生率、AZA不耐受对总不良反应发生率没有影响。所有不良反应自行恢复或相应治疗后恢复。结论 AZA治疗炎症性肠病因不良反应停药的比例约15%,应特别注意对用药第1个月的不良反应的监测。未出现不可逆或致死性不良反应。女性患者和增加用药剂量者白细胞降低的风险增加。
Objective To investigate the types, incidence, timing and outcome of azathioprine (AZA) treatment of inflammatory bowel disease (AD). Methods The clinical data of 85 patients with inflammatory bowel disease treated with azathioprine from March 1995 to September 2009 in Peking Union Medical College Hospital were analyzed retrospectively, including 37 cases of ulcerative colitis and 48 cases of Crohn’s disease. Results A total of 43 adverse reactions occurred in 37 patients (43.5%). Among them, 48% (20/43) of adverse reactions occurred within one month after treatment. Common adverse reactions are: 16 cases of blood system damage, 10 cases of infection, 9 cases of gastrointestinal reactions, liver damage in 5 cases, other adverse reactions are dizziness or headache, fatigue, joint pain, rash. 15% of patients (11/85) discontinued due to adverse reactions, including 3 cases of leukopenia, 2 cases of infection, gastrointestinal reaction, dizziness or headache, 1 case of arthralgia and rash, 55% (6/11) Drugs occurred in January medication. Logistic regression analysis showed that the incidence of leukopenia in female patients was 5.98 times that of male patients, and the total incidence of leukopenia in patients with AZA dose≥75mg / d was 4.89 times higher than those without. Age, sex, dosage, combined SASP, combined hormones and the relative incidence of infection time, AZA intolerance had no effect on the overall incidence of adverse reactions. All adverse reactions recovered on their own or after treatment. Conclusion AZA treatment of inflammatory bowel disease due to adverse drug withdrawal rate of about 15%, with special attention to the first month of adverse drug reactions monitoring. No irreversible or fatal adverse reactions occurred. Increased risk of leukopenia in female patients and at increased dosage.