肿瘤坏死因子-α拮抗剂治疗中国汉族人群强直性脊柱炎369例不良反应初步研究  

Adverse events of anti-tumour necrosis factor therapy for ankylosing spondylitis： a retrospective study of 369 Chinese Han population

作　　者：童强[1] 徐霞[1] 孔瑞娜[1] 庞亚飞[1] 吉连梅[1] 张菊[1] 张兰玲[1] 戴生明[1] 管剑龙[1] 韩星海[1] 赵东宝[1] 蔡青[1] 

机构地区：[1]第二军医大学附属长海医院风湿免疫科,上海200433

出　　处：《中华风湿病学杂志》2011年第11期785-788,共4页Chinese Journal of Rheumatology

基　　金：基金项目：上海市重点基金（08JC1406300）

摘　　要：目的旨在评价接受了肿瘤坏死因子（TNF）-α拮抗剂治疗的中国汉族人群强直性脊柱炎（AS）患者的不良反应，为生物制剂的临床治疗提供参考依据。方法本研究纳入在我科接受了TNF-α拮抗剂治疗的369例中国汉族人群AS患者，未完全跟踪随访给药1011次。所有患者均评估了用药后2h出现的不良反应，对其中126例长期用药患者进行了第8、12、52、104周的随访。观察患者用药后2h的短期不良反应和长期不良反应。采用Fisher确切概率法进行统计分析。结果接受TNF-（x拮抗剂治疗的369例AS患者，随访用药后2h共计发生30次不良反应。英夫利西单抗和重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白（rhTNFR：Fc）引起的短期不良反应发生率差异无统计学意义（分别为3．8％，2．6％，P=0．31）。126例患者分别依次进行了第8、12、52、104周的随访，共计39例发生不良反应，长期应用英夫利西单抗和rhTNFR：Fc不良反应发生率差异无统计学意义（分别为49％，51％，P=0．69）。结论中国汉族人群AS患者在接受TNF-α拮抗剂治疗时应注意上述不良反应的发生，尤其应注意第3、4次接受英夫利西单抗治疗患者的不良反应。接受英夫利西单抗和rhTNFR：Fc治疗的患者用药后2h内和长期（≥2年）治疗的不良反应发生相当。Objective To evaluate the adverse events occurred during turnout necrosis factor （TNF）-α blocker treatment in Chinese Han population patients with ankylosing spondylitis （AS）. Methods This：study had enrolled 369 Chinese Han population patients with ankylosing spondylitis. They all received TNF-α blocker treatment in the hospital. All 1011 administration were recorded in total. All of them were evaluated for adverse events 2 hours after injection, 126 of them had received long-term TNF-α blocker injection, and they were followed-up at week 8, 12, 52,104. Mild immediate adverse events and long-term adverse events were all counted. SPSS 10.0 software package was used for Fisher＇s exact test. Results Three hundred and sixty-nine patients had 1011 administrations in total, 652 had received rhTNFR：Fe, 316 had infliximab, 21 had etanercept, 22 had adalimumab injections. Adverse events 2 hours after injection were： 17 （2.6%） for rhTNFR：Fc, 12 （3.8%） for infliximab, 0 for etanercept, 1 （4.5%） for adalimumab. Twenty adverse events were mild （12 for rhTNFR：Fc, 9 for infliximab）, 5 events were moderate （3 for rhTNFR：Fe, 1 for infliximab, 1 for adalimumab）, 4 events were Severe （2 for rhTNFR：Fc, 2 for infliximab）. The frequency of adverse events were comparable between rhTNFR：Fc and Infliximab injection in immediate adverse reactions （P=0.31）. One hundred and twenty-six （69 rhTNFR：Fc, 57 infliximab） patients had long-term usage, and were followed-up at week 8, 12, 52, 104, 39 patients had adverse reactions： 20 （51.3%） for rhTNFR：Fe, 19（48.7%） for infliximab. Thirty-seven patients had infectious events（94.9%）, 1 neurological event（2.6%）, and 1 patient had tuberculosis relapse （2.6%）. Outcomes were comparable with rhTNFR：Fc and infliximab in long-term usage （P=0.69）. Conclusion Attention should be paid to the above events in Chinese Han patients with ankylosing spondylitis who were treated with TNF-α blocker treatment. Special attentio

关 键 词：脊柱炎 强直性 治疗结果 肿瘤坏死因子-Α拮抗剂 安全性 

分 类 号：R593.23[医药卫生—内科学]