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

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-α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rhTN FR: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.

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

Objective To evaluate the adverse events occurred during tumour necrosis factor (TNF)-αblocker 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-αblocker 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:Fc,316 had infliximab,21had 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:Fc,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:Fc,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 attention should be paid to those patients who are in their third or fourth injection.The occurrence of immediate reaction or long-term adverse events between rhTNFR:Fc and infliximab are comparable.