肿瘤坏死因子拮抗剂在治疗强直性脊柱炎中的安全性分析  

A cohort analysis of safety tumor necrosis factor-α antagonists in the treatment of Chinese patients with ankylosing spondylitis

作　　者：王莉莎[1] 黄烽[1] 张江林[1] 邓小虎[1] 张亚美[1] 张莉芸[1] 郭军华[1] 

机构地区：[1]中国人民解放军总医院风湿科,北京100853

出　　处：《中国新药杂志》2007年第7期556-561,共6页Chinese Journal of New Drugs

基　　金：国家自然科学基金(30571726)

摘　　要：目的:分析肿瘤坏死因子-α拮抗剂在治疗强直性脊柱炎(AS)患者过程中所发生的不良反应,评价其临床应用的安全性和耐受性。方法:对应用英利昔单抗(infliximab)和依那西普(etanercept)治疗期间及随访过程中AS患者所发生的全部不良事件、严重不良事件、实验室检查等进行总结分析,根据世界卫生组织不良反应术语命名(WHOART)系统进行分类,观察不良事件的发生情况。结果:英利昔单抗治疗63例AS患者中,21例(33.33%)患者发生了至少43例次与治疗药物相关的不良反应,主要为上呼吸道感染、皮肤及其附件损害等,2例患者发生严重的皮炎伴脱发,1例在第3次输注药物过程中出现输注反应。共有142例AS患者入选依那西普临床试验,随机分配,治疗组70例,安慰剂组72例,双盲治疗期安慰剂组和依那西普组的不良事件发生率分别为29.17%和40.00%,两组比较差异无统计学意义(P>0.05),与治疗相关的不良事件安慰剂组和依那西普组分别为20.83%和38.57%;开放治疗期内全部不良事件发生率在安慰剂组和依那西普组分别为41.67%和32.86%,两组比较差异也没有统计学意义(P>0.05),与药物相关的不良事件分别为40.28%和30.00%;依那西普最常见的不良反应是注射局部反应、皮肤及其附件的损害、白细胞分类中淋巴细胞比例升高和呼吸道感染等。结论:短期临床观察显示,肿瘤坏死因子拮抗剂英利昔单抗和依那西普治疗AS的耐受性和安全性较好。Objective： To evaluate the safety and tolerance of tumor necrosis factor-α（TNF-α） antagonists in the treatment of Chinese patients with ankylosing spondylitis （AS）. Methods： A retrospective analysis of incidence rate of adverse events （ AE）, serious adverse events （SAE） and laboratory test abnormal outcomes was conducted for patients with AS who were treated with infliximab and etanercept according to WHOART systematic classification by World Health Organization. Results： Of 63 AS patients treated with infliximab alone, 21 patients （33.33%） experienced 43 AEs associated to infliximab, including upper respiratory infection and skin and appendage disorders, 2 developed severe dermatitis accompanied with alopecia, and 1 had infusion reaction during his third infusion. In a randomized and double blind clinical study, 142 AS patients were randomly administered with either etanercept （n = 70） or placebo （n = 72）. In the double blind portion of the clinical study, events patients administered with placebo or etanercept experienced was 29 the incidence rate of adverse 17% and 40.00% , respectively （P 〉0.05）. The incidence of AEs associated to both regimens was 20.83% versus 38.57%. In the open label portion of the clinical study, the total incidence of AEs the placebo- and etanercept-treated patients experienced was 41.67% and 32.86% , respectively （P 〉 0.05）. The incidence of AEs associated to both regimens was 40.28% versus 30.00%. The most common AEs of etanercept included injection site reaction, skin and appendage disorders, proportion of lymphocyte increasing and respiratory infection. Conclusion ：These TNF-α antagonists infliximab and etanercept were safe and well tolerated for Chinese patients. A long-term assessment of the safety of these TNF-α is essential.

关 键 词：肿瘤坏死因子拮抗剂 英利昔单抗 依那西普 强直性脊柱炎 不良事件 

分 类 号：R593.23[医药卫生—内科学] R994.11[医药卫生—临床医学]